Trial Outcomes & Findings for Autologous Muscle Derived Cells for Female Urinary Sphincter Repair (NCT NCT01893138)
NCT ID: NCT01893138
Last Updated: 2023-01-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
311 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2023-01-05
Participant Flow
311 subjects were enrolled (underwent biopsy procedure) and 297 subjects underwent study treatment with iltamiocel (199 subjects) or placebo (98 subjects). Analysis population is based on 297 subjects that underwent study treatment. At randomization, participants stratified by presence or absence of prior incontinence surgery and by \< 10 or ≥10 stress incontinence episodes over 3 day diary at screening.
Participant milestones
| Measure |
Iltamiocel
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Double-Blind Period
STARTED
|
199
|
98
|
|
Double-Blind Period
Injection
|
199
|
98
|
|
Double-Blind Period
1 Month Follow-Up
|
199
|
97
|
|
Double-Blind Period
3 Month Follow-Up
|
199
|
97
|
|
Double-Blind Period
6 Month Follow-Up
|
198
|
97
|
|
Double-Blind Period
12 Month Follow-Up
|
198
|
97
|
|
Double-Blind Period
COMPLETED
|
198
|
97
|
|
Double-Blind Period
NOT COMPLETED
|
1
|
1
|
|
Open Label - Unblinded Period
STARTED
|
198
|
97
|
|
Open Label - Unblinded Period
Open Label Period
|
166
|
97
|
|
Open Label - Unblinded Period
Iltamiocel Injection
|
0
|
92
|
|
Open Label - Unblinded Period
2 Year Follow-Up
|
166
|
87
|
|
Open Label - Unblinded Period
COMPLETED
|
166
|
87
|
|
Open Label - Unblinded Period
NOT COMPLETED
|
32
|
10
|
Reasons for withdrawal
| Measure |
Iltamiocel
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Double-Blind Period
Withdrawal by Subject
|
1
|
1
|
|
Open Label - Unblinded Period
Lack of Efficacy
|
9
|
0
|
|
Open Label - Unblinded Period
Lost to Follow-up
|
4
|
3
|
|
Open Label - Unblinded Period
Withdrawal by Subject
|
18
|
7
|
|
Open Label - Unblinded Period
Adverse Event
|
1
|
0
|
Baseline Characteristics
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Baseline characteristics by cohort
| Measure |
Iltamiocel
n=199 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=98 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 10.9 • n=39 Participants
|
55.0 years
STANDARD_DEVIATION 10.7 • n=41 Participants
|
54.4 years
STANDARD_DEVIATION 10.8 • n=35 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=39 Participants
|
98 Participants
n=41 Participants
|
297 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
196 Participants
n=39 Participants
|
93 Participants
n=41 Participants
|
289 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
184 Participants
n=39 Participants
|
89 Participants
n=41 Participants
|
273 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=39 Participants
|
1 participants
n=41 Participants
|
3 participants
n=35 Participants
|
|
Region of Enrollment
United States
|
193 participants
n=39 Participants
|
94 participants
n=41 Participants
|
287 participants
n=35 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=39 Participants
|
3 participants
n=41 Participants
|
7 participants
n=35 Participants
|
|
Stress Incontinence Episodes Over 3 Day Diary
|
14.2 stress leaks
STANDARD_DEVIATION 9.8 • n=39 Participants
|
15 stress leaks
STANDARD_DEVIATION 14.2 • n=41 Participants
|
14.5 stress leaks
STANDARD_DEVIATION 11.4 • n=35 Participants
|
|
24 Hour Pad Test Weight
|
47.6 grams
STANDARD_DEVIATION 91.8 • n=39 Participants
|
40.9 grams
STANDARD_DEVIATION 52.8 • n=41 Participants
|
45.2 grams
STANDARD_DEVIATION 81.1 • n=35 Participants
|
|
Incontinence Quality of Life (IQOL) Assessment -Total Score
|
59.0 scores on scales
STANDARD_DEVIATION 21.0 • n=39 Participants
|
59.5 scores on scales
STANDARD_DEVIATION 20.2 • n=41 Participants
|
59.2 scores on scales
STANDARD_DEVIATION 20.0 • n=35 Participants
|
|
7-Item Incontinence Impact Questionnaire - Short Form (IIQ-7)
|
44.4 scores on scales
STANDARD_DEVIATION 20.9 • n=39 Participants
|
43.7 scores on scales
STANDARD_DEVIATION 21.8 • n=41 Participants
|
44.2 scores on scales
STANDARD_DEVIATION 21.2 • n=35 Participants
|
|
6-Item Urogenital Distress Inventory Score - Short Form (UDI-6)
|
38.5 scores on scales
STANDARD_DEVIATION 16 • n=39 Participants
|
40.5 scores on scales
STANDARD_DEVIATION 18.4 • n=41 Participants
|
39.2 scores on scales
STANDARD_DEVIATION 16.8 • n=35 Participants
|
|
Global Quality of Life Assessment (GQOL)
|
5.7 scores on scales
STANDARD_DEVIATION 1.0 • n=39 Participants
|
5.6 scores on scales
STANDARD_DEVIATION 1.1 • n=41 Participants
|
5.7 scores on scales
STANDARD_DEVIATION 1.0 • n=35 Participants
|
|
Incontinence Severity Index (ISI)
|
7.6 scores on scales
STANDARD_DEVIATION 2.4 • n=39 Participants
|
7.4 scores on scales
STANDARD_DEVIATION 2.8 • n=41 Participants
|
7.5 scores on scales
STANDARD_DEVIATION 2.5 • n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: All participants with baseline and 12 month 3 day diary data
Outcome measures
| Measure |
Iltamiocel
n=198 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=97 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
|
103 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: All participants with baseline and 12 month 3 day diary data
Outcome measures
| Measure |
Iltamiocel
n=198 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=97 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months
|
73 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: All participants with baseline and 12 month diary data
Outcome measures
| Measure |
Iltamiocel
n=198 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=97 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months
|
53 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: All participants with baseline and 12 month 3 day diary data
Outcome measures
| Measure |
Iltamiocel
n=198 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=97 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months
|
-5.8 stress leaks
Standard Deviation 11
|
-4.9 stress leaks
Standard Deviation 13.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 monthsPopulation: All participants with baseline and 12 month diary data
Spearman's correlation used for analysis
Outcome measures
| Measure |
Iltamiocel
n=198 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=96 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency
Association of IQOL improvement with stress incontinence episode reduction at 12 months
|
-0.556 correlation coefficient
|
-0.456 correlation coefficient
|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency
Association of IIQ-7 improvement with stress incontinence episode reduction at 12 months
|
0.522 correlation coefficient
|
0.442 correlation coefficient
|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency
Association of UDI-6 improvement with stress incontinence episode reduction at 12 months
|
0.408 correlation coefficient
|
0.433 correlation coefficient
|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency
Association of GQOL improvement with stress incontinence episode reduction at 12 months
|
0.537 correlation coefficient
|
0.422 correlation coefficient
|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency
Association of ISI improvement with stress incontinence episode reduction at 12 months
|
0.529 correlation coefficient
|
0.599 correlation coefficient
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 months, and 24 months after injection with iltamiocelPopulation: All participants who received iltamiocel treatment during the double-blind period and with 12-month and 24-month stress incontinence episode frequency (SIEF) diary data. Participants who received placebo treatment in the double-blind period are not included due to receiving iltamiocel treatment in the open-label period after unblinding or were exited from the study.
Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months
Outcome measures
| Measure |
Iltamiocel
n=199 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Treatment Durability at 24 Months
Participants that had ≥ 50% reduction in stress incontinence episodes at Month 12 and Month 24 data
|
80 Participants
|
—
|
|
Treatment Durability at 24 Months
Participants that had ≥ 75% reduction in stress incontinence episodes at Month 12 and Month 24 data
|
50 Participants
|
—
|
|
Treatment Durability at 24 Months
Participants that had ≤1 stress incontinence episodes at Month 12 and Month 24 data
|
36 Participants
|
—
|
POST_HOC outcome
Timeframe: Baseline and 12 monthsParticipants with a history of prior SUI surgery with baseline and 12 month diary data.
Outcome measures
| Measure |
Iltamiocel
n=50 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=25 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only)
|
20 Participants
|
4 Participants
|
POST_HOC outcome
Timeframe: Baseline and 12 monthsParticipants with a history of prior SUI surgery with baseline and 12 month diary data.
Outcome measures
| Measure |
Iltamiocel
n=50 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=25 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months (Prior Surgery Participants Only)
|
14 Participants
|
3 Participants
|
POST_HOC outcome
Timeframe: Baseline and 12 monthsParticipants with a history of prior SUI surgery with baseline and 12 month diary data.
Outcome measures
| Measure |
Iltamiocel
n=50 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=25 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only)
|
-6.7 stress leaks
Standard Deviation 14.5
|
-4.5 stress leaks
Standard Deviation 11.5
|
POST_HOC outcome
Timeframe: Baseline and 12 monthsPopulation: All participants with prior surgery and baseline and 12 month diary data
Spearman's correlation used for analysis
Outcome measures
| Measure |
Iltamiocel
n=50 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
n=25 Participants
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency (Prior Surgery Participants Only)
Association of IQOL improvement with stress incontinence episode reduction at 12 months
|
-0.489 correlation coefficient
|
-0.460 correlation coefficient
|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency (Prior Surgery Participants Only)
Association of IIQ-7 improvement with stress incontinence episode reduction at 12 months
|
0.427 correlation coefficient
|
0.542 correlation coefficient
|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency (Prior Surgery Participants Only)
Association of UDI-6 improvement with stress incontinence episode reduction at 12 months
|
0.424 correlation coefficient
|
0.604 correlation coefficient
|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency (Prior Surgery Participants Only)
Association of GQOL improvement with stress incontinence episode reduction at 12 months
|
0.561 correlation coefficient
|
0.190 correlation coefficient
|
|
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency (Prior Surgery Participants Only)
Association of ISI improvement with stress incontinence episode reduction at 12 months
|
0.426 correlation coefficient
|
0.476 correlation coefficient
|
POST_HOC outcome
Timeframe: Baseline, 12 months, and 24 months after injection with iltamiocelPopulation: Prior surgery participants who received iltamiocel treatment during the double-blind period with 12-month and 24-month stress incontinence episode frequency (SIEF) diary data. Prior surgery participants who received placebo treatment in the double-blind period are not included due to receiving iltamiocel treatment in the open-label period after unblinding or were exited from the study.
Treatment durability defined as participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained response at 24 months
Outcome measures
| Measure |
Iltamiocel
n=53 Participants
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
|---|---|---|
|
Treatment Durability at 24 Months (Prior Surgery Participants)
Participants that had ≥ 50% reduction in stress incontinence episodes at Month 12 and Month 24 data
|
19 Participants
|
—
|
|
Treatment Durability at 24 Months (Prior Surgery Participants)
Participants that had ≥ 75% reduction in stress incontinence episodes at Month 12 and Month 24 data
|
12 Participants
|
—
|
|
Treatment Durability at 24 Months (Prior Surgery Participants)
Participants that had ≤1 stress incontinence episodes at Month 12 and Month 24 data
|
11 Participants
|
—
|
Adverse Events
Iltamiocel - Double-Blind Period
Serious events: 11 serious events
Other events: 84 other events
Deaths: 0 deaths
Placebo - Double-Blind Period
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Iltamiocel - Unblinded Period
Serious events: 12 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo Receiving Open Label Iltamiocel in Unblinded Period
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iltamiocel - Double-Blind Period
n=199 participants at risk
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo - Double-Blind Period
n=98 participants at risk
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
Iltamiocel - Unblinded Period
n=198 participants at risk
Subjects who received iltamiocel in double-blind period. No additional treatment for iltamiocel arm in unblinded period.
|
Placebo Receiving Open Label Iltamiocel in Unblinded Period
n=92 participants at risk
Subjects who received placebo in double-blind period and elected to receive iltamiocel injection in unblinded period. Single intraurethral injection of 150 x 10\^6 cells.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Cardiac disorders
Coronary artery dissection
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
General disorders
Chest pain
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Immune system disorders
Hypersensitivity
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Sepsis
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Staphylococcal infection
|
1.0%
2/199 • Number of events 2 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Pneumonia
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Pyelonephritis
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Viral infection
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Psychiatric disorders
Major depression
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Psychiatric disorders
Suicide attempt
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.1%
1/92 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.50%
1/199 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.0%
2/199 • Number of events 2 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
General disorders
Fatigue
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.1%
1/92 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Influenza
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.1%
1/92 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.1%
1/92 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.1%
1/92 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.1%
1/92 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Vascular disorders
Hypertension
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.1%
1/92 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Vascular disorders
Subgaleal haematoma
|
0.00%
0/199 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/98 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/92 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
Other adverse events
| Measure |
Iltamiocel - Double-Blind Period
n=199 participants at risk
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
|
Placebo - Double-Blind Period
n=98 participants at risk
Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
|
Iltamiocel - Unblinded Period
n=198 participants at risk
Subjects who received iltamiocel in double-blind period. No additional treatment for iltamiocel arm in unblinded period.
|
Placebo Receiving Open Label Iltamiocel in Unblinded Period
n=92 participants at risk
Subjects who received placebo in double-blind period and elected to receive iltamiocel injection in unblinded period. Single intraurethral injection of 150 x 10\^6 cells.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Dysuria
|
10.1%
20/199 • Number of events 20 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
7.1%
7/98 • Number of events 8 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.51%
1/198 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
6.5%
6/92 • Number of events 6 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
General disorders
Injection site pain
|
5.0%
10/199 • Number of events 11 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
0.00%
0/198 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.1%
1/92 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Urinary tract infection
|
18.1%
36/199 • Number of events 53 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
14.3%
14/98 • Number of events 19 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
7.1%
14/198 • Number of events 16 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
10.9%
10/92 • Number of events 12 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
7/199 • Number of events 8 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
5.1%
5/98 • Number of events 6 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
2/198 • Number of events 2 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
3.3%
3/92 • Number of events 3 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
|
Infections and infestations
Sinusitis
|
5.5%
11/199 • Number of events 11 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
1.0%
1/98 • Number of events 1 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
2.0%
4/198 • Number of events 4 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
2.2%
2/92 • Number of events 2 • 12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60