Trial Outcomes & Findings for Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers (NCT NCT01859117)
NCT ID: NCT01859117
Last Updated: 2026-06-04
Results Overview
Number of participants with treatment-emergent adverse events following administration of PDA-002.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
From first dose through month 24
Results posted on
2026-06-04
Participant Flow
A total of 15 participants were enrolled across 4 sequential dose-escalation cohorts in this Phase 1 open-label study conducted at multiple sites in the United States.
Participants were assigned sequentially to 1 of 4 dose-escalation cohorts based on order of enrollment. Dose escalation proceeded after review of available safety data from previously enrolled participants.
Participant milestones
| Measure |
3 x10^6 Cells
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 3 × 10\^6 cells.
|
10 x 10^6 Cells
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 10 × 10\^6 cells.
|
30 x 10^6 Cells
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 30 × 10\^6 cells.
|
100 x 10^6 Cells
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 100 × 10\^6 cells.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
2
|
1
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
3 x10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 3 × 10\^6 cells.
|
10 x 10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 10 × 10\^6 cells.
|
30 x 10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 30 × 10\^6 cells.
|
100 x 10^6 Cells
n=6 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 100 × 10\^6 cells.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 6.43 • n=9 Participants
|
67.3 years
STANDARD_DEVIATION 6.66 • n=27 Participants
|
65 years
STANDARD_DEVIATION 9.85 • n=267 Participants
|
70.8 years
STANDARD_DEVIATION 9.66 • n=265 Participants
|
69.1 years
STANDARD_DEVIATION 8.15 • n=568 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
11 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
14 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Through Day 15 following initial dosingPopulation: All 15 subjects
Number of participants with dose-limiting toxicities following intramuscular administration of PDA-002. Dose-limiting toxicity was used to evaluate maximum tolerated dose.
Outcome measures
| Measure |
3 x10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 3 × 10\^6 cells.
|
10 x 10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 10 × 10\^6 cells.
|
30 x 10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 30 × 10\^6 cells.
|
100 x 10^6 Cells
n=6 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 100 × 10\^6 cells.
|
|---|---|---|---|---|
|
Dose Limiting Toxicity (DLTs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From first dose through month 24Population: All 15 subjects
Number of participants with treatment-emergent adverse events following administration of PDA-002.
Outcome measures
| Measure |
3 x10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 3 × 10\^6 cells.
|
10 x 10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 10 × 10\^6 cells.
|
30 x 10^6 Cells
n=3 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 30 × 10\^6 cells.
|
100 x 10^6 Cells
n=6 Participants
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 100 × 10\^6 cells.
|
|---|---|---|---|---|
|
Treatment-Emergent Adverse Events (TEAEs)
|
3 participants
|
3 participants
|
2 participants
|
6 participants
|
Adverse Events
3 x10^6 Cells
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
10 x 10^6 Cells
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
30 x 10^6 Cells
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
100 x 10^6 Cells
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3 x10^6 Cells
n=3 participants at risk
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 3 × 10\^6 cells.
|
10 x 10^6 Cells
n=3 participants at risk
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 10 × 10\^6 cells.
|
30 x 10^6 Cells
n=3 participants at risk
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 30 × 10\^6 cells.
|
100 x 10^6 Cells
n=6 participants at risk
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 100 × 10\^6 cells.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/6 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Osteomyelitis
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
16.7%
1/6 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/6 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/6 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Cardiac disorders
Acute Myocardial Infarcation
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/6 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
Other adverse events
| Measure |
3 x10^6 Cells
n=3 participants at risk
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 3 × 10\^6 cells.
|
10 x 10^6 Cells
n=3 participants at risk
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 10 × 10\^6 cells.
|
30 x 10^6 Cells
n=3 participants at risk
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 30 × 10\^6 cells.
|
100 x 10^6 Cells
n=6 participants at risk
Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 100 × 10\^6 cells.
|
|---|---|---|---|---|
|
Infections and infestations
Osteomyelitis
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
66.7%
2/3 • Number of events 2 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
16.7%
1/6 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/6 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/6 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
16.7%
1/6 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
16.7%
1/6 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
2/6 • Number of events 2 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
66.7%
2/3 • Number of events 2 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
16.7%
1/6 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/6 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/3 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/6 • From first dose through Month 24
Adverse events were collected from the time of first dose through the end of study participation. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place