Trial Outcomes & Findings for Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis (NCT NCT05092646)
NCT ID: NCT05092646
Last Updated: 2026-08-07
Results Overview
The Ankle Osteoarthritis Scale (AOS) pain subscale goes from 0 (No pain) -100 (The worst imaginable).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
4-weeks, 3-months, and 6-months
Results posted on
2026-08-07
Participant Flow
Participant milestones
| Measure |
Control Group
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Sex/Gender, Customized
Male or Female
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 4-weeks, 3-months, and 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
The Ankle Osteoarthritis Scale (AOS) pain subscale goes from 0 (No pain) -100 (The worst imaginable).
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Change From Baseline in Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Pain Subscale
4-weeks
|
-7.0 score on a scale
Standard Deviation 24.08
|
-2.2 score on a scale
Standard Deviation 23.32
|
|
Change From Baseline in Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Pain Subscale
3-months
|
-11.7 score on a scale
Standard Deviation 31.97
|
19.3 score on a scale
Standard Deviation 32.75
|
|
Change From Baseline in Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Pain Subscale
6-months
|
-4.5 score on a scale
Standard Deviation 12.47
|
6.3 score on a scale
Standard Deviation 16.26
|
PRIMARY outcome
Timeframe: 4-week, 3 Months, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
The Ankle Osteoarthritis Scale (AOS) functions subscale goes from 0 (No difficulty) -100 (So difficult, unable).
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Change From Baseline for Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Function Subscale
4-weeks
|
-13.3 score on a scale
Standard Deviation 23.55
|
-0.6 score on a scale
Standard Deviation 23.51
|
|
Change From Baseline for Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Function Subscale
3-months
|
-14.2 score on a scale
Standard Deviation 19.05
|
12.3 score on a scale
Standard Deviation 24.03
|
|
Change From Baseline for Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Function Subscale
6-months
|
-7.3 score on a scale
Standard Deviation 7.74
|
8.7 score on a scale
Standard Deviation 21.08
|
PRIMARY outcome
Timeframe: 4-weeks, 3-months, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
A score of 100 represents no pain. A score of 0 constant pain.
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Pain Subscale
4-weeks
|
10.0 score on a scale
Standard Deviation 15.97
|
5.8 score on a scale
Standard Deviation 22.33
|
|
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Pain Subscale
3-months
|
16.5 score on a scale
Standard Deviation 14.60
|
-13.0 score on a scale
Standard Deviation 20.42
|
|
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Pain Subscale
6-months
|
8.8 score on a scale
Standard Deviation 7.79
|
-6.3 score on a scale
Standard Deviation 12.66
|
PRIMARY outcome
Timeframe: 4-weeks, 3-months, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
100 represents perfect health and 0 represents extreme problems and complete functional limitation. .
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Function Subscale
6-months
|
4.7 score on a scale
Standard Deviation 2.50
|
-3.3 score on a scale
Standard Deviation 7.37
|
|
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Function Subscale
3-months
|
8.5 score on a scale
Standard Deviation 7.92
|
-6.7 score on a scale
Standard Deviation 10.97
|
|
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Function Subscale
4-weeks
|
5.0 score on a scale
Standard Deviation 8.69
|
2.8 score on a scale
Standard Deviation 11.82
|
PRIMARY outcome
Timeframe: 4-weeks, 3-months, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
CCS defined as a patient meeting all of the three following criteria: 1. Improvement in AOS (Pain and Function) or FAOS scores (Pain and ADL) of at least 20% from baseline 2. No surgical intervention or prescription pain medications for ankle OA 3. No treatment or procedure-related serious adverse events
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Proportion of Patients Achieving Composite Clinical Success (CCS).
4-weeks
|
3 Participants
|
1 Participants
|
|
Proportion of Patients Achieving Composite Clinical Success (CCS).
3-months
|
3 Participants
|
1 Participants
|
|
Proportion of Patients Achieving Composite Clinical Success (CCS).
6-months
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-procedure follow-up assessments: 4 weeks (+/-7days), 3 Months (+/- 14 days), 6 Months (+/- 30 days), 12 Months (+/- 60 days), and unscheduled visits (up to 19 months)Population: Modified intent to treat population; all enrolled randomized subjects who received an injection.
Proportion of subjects experiencing at least (1) adverse events.
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Incidence of Adverse Events
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4-week, 3-month, 6-monthPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
0 (most severe problems) to 100 (no problems/best possible qualify of life)
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
FAOS Subscales Quality of Life (QoL)
4-weeks
|
12.5 score on a scale
Standard Deviation 17.27
|
11.4 score on a scale
Standard Deviation 38.62
|
|
FAOS Subscales Quality of Life (QoL)
3-months
|
14.5 score on a scale
Standard Deviation 20.39
|
0.0 score on a scale
Standard Deviation 13.00
|
|
FAOS Subscales Quality of Life (QoL)
6-months
|
9.0 score on a scale
Standard Deviation 18.60
|
2.0 score on a scale
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: 4 weeks, 3-months, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
100 millimeter scale 0mm - No Pain and 100mm - Worst Imaginable Pain
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Visual Analog Scale (VAS) for Ankle Pain (Average During Last 48 Hours)
4-weeks
|
3.0 score on a scale
Standard Deviation 43.69
|
-0.6 score on a scale
Standard Deviation 33.47
|
|
Visual Analog Scale (VAS) for Ankle Pain (Average During Last 48 Hours)
3-months
|
-12.2 score on a scale
Standard Deviation 40.91
|
26.0 score on a scale
Standard Deviation 29.00
|
|
Visual Analog Scale (VAS) for Ankle Pain (Average During Last 48 Hours)
6-months
|
-15.3 score on a scale
Standard Deviation 14.29
|
8.7 score on a scale
Standard Deviation 15.82
|
SECONDARY outcome
Timeframe: 4-weeks, 3-months, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
100 millimeter scale 0mm - No Pain and 100mm - Worst Imaginable Pain
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
VAS Ankle Pain (Worst During Last 48 Hours)
4-weeks
|
-4.2 score on a scale
Standard Deviation 32.85
|
2.2 score on a scale
Standard Deviation 38.80
|
|
VAS Ankle Pain (Worst During Last 48 Hours)
3-months
|
-11.2 score on a scale
Standard Deviation 39.21
|
35.3 score on a scale
Standard Deviation 35.92
|
|
VAS Ankle Pain (Worst During Last 48 Hours)
6-months
|
-13.7 score on a scale
Standard Deviation 16.77
|
5.0 score on a scale
Standard Deviation 10.00
|
SECONDARY outcome
Timeframe: 4-weeks, 3-months, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
0 to 100 scale - 0 the worst health you can imagine to 100 the best health you can imagine.
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
EuroQOL-5 Dimension-5 Level (EQ-5D-5L) Quality of Life Scale
6-months
|
-5.7 score on a scale
Standard Deviation 29.14
|
-6.7 score on a scale
Standard Deviation 7.64
|
|
EuroQOL-5 Dimension-5 Level (EQ-5D-5L) Quality of Life Scale
3-months
|
-0.2 score on a scale
Standard Deviation 20.74
|
-20.0 score on a scale
Standard Deviation 21.79
|
|
EuroQOL-5 Dimension-5 Level (EQ-5D-5L) Quality of Life Scale
4-weeks
|
8.3 score on a scale
Standard Deviation 13.94
|
-0.4 score on a scale
Standard Deviation 21.87
|
SECONDARY outcome
Timeframe: Baseline, 4-weeks, 3-months, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
Not working, unrelated to ankle Not working, related to ankle Working with major limitations related to ankle Working without limitations related to ankle
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Working Status
Baseline · Not working, unrelated to ankle
|
2 Participants
|
1 Participants
|
|
Working Status
Baseline · Not working, related to ankle
|
1 Participants
|
0 Participants
|
|
Working Status
Baseline · Working with major limitations related to ankle
|
0 Participants
|
1 Participants
|
|
Working Status
Baseline · Working without limitations related to ankle
|
3 Participants
|
4 Participants
|
|
Working Status
4-weeks · Not working, unrelated to ankle
|
1 Participants
|
1 Participants
|
|
Working Status
4-weeks · Not working, related to ankle
|
0 Participants
|
0 Participants
|
|
Working Status
4-weeks · Working with major limitations related to ankle
|
2 Participants
|
0 Participants
|
|
Working Status
4-weeks · Working without limitations related to ankle
|
3 Participants
|
4 Participants
|
|
Working Status
3months · Not working, unrelated to ankle
|
1 Participants
|
0 Participants
|
|
Working Status
3months · Not working, related to ankle
|
0 Participants
|
0 Participants
|
|
Working Status
3months · Working with major limitations related to ankle
|
2 Participants
|
1 Participants
|
|
Working Status
3months · Working without limitations related to ankle
|
3 Participants
|
2 Participants
|
|
Working Status
6months · Not working, unrelated to ankle
|
2 Participants
|
0 Participants
|
|
Working Status
6months · Not working, related to ankle
|
0 Participants
|
0 Participants
|
|
Working Status
6months · Working with major limitations related to ankle
|
2 Participants
|
1 Participants
|
|
Working Status
6months · Working without limitations related to ankle
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6-monthsPopulation: Modified intent to treat population; all enrolled randomized subjects who received an injection.
Grade 2 Definite osteophytes with mild to moderate joint space narrowing; early radiographic OA Grade 3a Significant osteophytes and joint space narrowing, but greater than 50% of the joint space remains preserved Grade 3b Severe joint space narrowing with less than 50% remaining joint space, approaching end-stage disease but not completely bone-on-bone Grade 4 Near complete or complete loss of joint space with substantial deformity (end-stage OA)
Outcome measures
| Measure |
Control Group
n=6 Participants
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 Participants
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
baseline Day 0 · Grade 2 Definite osteophytes with mild to moderate joint space narrowing; early radiographic OA
|
4 Participants
|
2 Participants
|
|
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
baseline Day 0 · Grade 3a
|
1 Participants
|
3 Participants
|
|
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
baseline Day 0 · Grade 3b
|
1 Participants
|
0 Participants
|
|
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
baseline Day 0 · Grade 4
|
0 Participants
|
0 Participants
|
|
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
6 Month · Grade 2 Definite osteophytes with mild to moderate joint space narrowing; early radiographic OA
|
3 Participants
|
0 Participants
|
|
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
6 Month · Grade 3a
|
1 Participants
|
1 Participants
|
|
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
6 Month · Grade 3b
|
0 Participants
|
0 Participants
|
|
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
6 Month · Grade 4
|
0 Participants
|
0 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Investigational Group
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 |
Control Group
n=6 participants at risk
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
"Drug/Placebo: 0.9% Normal Saline": "Drug/Placebo: 0.9% Normal Saline"
|
Investigational Group
n=6 participants at risk
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Axolotl Ambient: Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Injury
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
16.7%
1/6 • Number of events 1 • 19 months
Adverse events were collected during follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Left Hip Osteoarthritis
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
16.7%
1/6 • Number of events 1 • 19 months
Adverse events were collected during follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
50.0%
3/6 • Number of events 5 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
33.3%
2/6 • Number of events 2 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Foot and Ankle Pain
|
50.0%
3/6 • Number of events 7 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
16.7%
1/6 • Number of events 1 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
16.7%
1/6 • Number of events 1 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Foot Numbness
|
16.7%
1/6 • Number of events 1 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Wrist Pain
|
16.7%
1/6 • Number of events 1 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
16.7%
1/6 • Number of events 1 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
|
Immune system disorders
Vaccination Reaction
|
16.7%
1/6 • Number of events 1 • 19 months
Adverse events were collected during follow-up visits.
|
0.00%
0/6 • 19 months
Adverse events were collected during follow-up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER