Trial Outcomes & Findings for STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia (NCT NCT02503852)
NCT ID: NCT02503852
Last Updated: 2020-01-13
Results Overview
Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Enrollment to 52 weeks
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
Fat + High Dose ADRC
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat + Low Dose ADRC
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat Alone
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
No Fat Control
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
22
|
24
|
9
|
|
Overall Study
COMPLETED
|
12
|
19
|
21
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia
Baseline characteristics by cohort
| Measure |
Fat + High Dose ADRC
n=16 Participants
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat + Low Dose ADRC
n=22 Participants
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat Alone
n=24 Participants
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
No Fat Control
n=9 Participants
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age(Years)
|
40.0 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
43.1 years
STANDARD_DEVIATION 13.3 • n=107 Participants
|
40.5 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
36.1 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 11.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
67 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Enrollment to 52 weeksSafety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
Outcome measures
| Measure |
Fat + High Dose ADRC
n=16 Participants
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat + Low Dose ADRC
n=22 Participants
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat Alone
n=24 Participants
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
No Fat Control
n=9 Participants
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
|---|---|---|---|---|
|
Safety & Tolerability Assessment of SAE/AE
Unanticipated Adverse Eventss
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Safety & Tolerability Assessment of SAE/AE
Serious Adverse Events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Safety & Tolerability Assessment of SAE/AE
Total Number of Adverse Events
|
5 events
|
9 events
|
12 events
|
2 events
|
SECONDARY outcome
Timeframe: Enrollment to 52 weeksPopulation: mITT, Baseline Norwood-Hamilton III
Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
Outcome measures
| Measure |
Fat + High Dose ADRC
n=6 Participants
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat + Low Dose ADRC
n=11 Participants
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat Alone
n=5 Participants
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
No Fat Control
n=4 Participants
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
|---|---|---|---|---|
|
Terminal (Non-Vellus) Hair Count--Change From Baseline
|
-5.62 Hairs
Standard Error 6.09
|
16.2 Hairs
Standard Error 4.98
|
-0.57 Hairs
Standard Error 7.53
|
-7.92 Hairs
Standard Error 8.98
|
SECONDARY outcome
Timeframe: Enrollment to 24 weeksPopulation: The Baseline NW3 subgroup included all male subjects with baseline Norwood Scale III, III-A and III-V.
Percent of positive responses, defined by increase of 1 or more from baseline, on specific written assessment of treatment outcome by Investigators scored 1-5, value 1 is lowest, value of 5 is highest, higher values represent more positive responses
Outcome measures
| Measure |
Fat + High Dose ADRC
n=6 Participants
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat + Low Dose ADRC
n=7 Participants
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat Alone
n=12 Participants
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
No Fat Control
n=3 Participants
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
|---|---|---|---|---|
|
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4
|
12.5 % of participants with + responses
|
34.4 % of participants with + responses
|
20.8 % of participants with + responses
|
4.1 % of participants with + responses
|
Adverse Events
Fat + High Dose ADRC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fat + Low Dose ADRC
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Fat Alone
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
No Fat Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fat + High Dose ADRC
n=16 participants at risk
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat + Low Dose ADRC
n=22 participants at risk
Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
Fat Alone
n=24 participants at risk
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
No Fat Control
n=9 participants at risk
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Brusing or Edema
|
31.2%
5/16 • Number of events 5 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
36.4%
8/22 • Number of events 8 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
45.8%
11/24 • Number of events 11 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
22.2%
2/9 • Number of events 2 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
|
Immune system disorders
Shilgles
|
0.00%
0/16 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
0.00%
0/22 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
4.2%
1/24 • Number of events 1 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
0.00%
0/9 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
|
Respiratory, thoracic and mediastinal disorders
Hickups
|
0.00%
0/16 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
4.5%
1/22 • Number of events 1 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
0.00%
0/24 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
0.00%
0/9 • From Enrollment through 52 Weeks
Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place