CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled / 15 target
Drug / intervention
PDA-002biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01859117
NCT01859117Phase 1CompletedUpdate Overdue (0.1/mo)Completion was 116mo ago
CompareCT.gov

A Phase 1 Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers

Celularity Incorporated·interventional·Posted May 21, 2013·Updated Jun 4, 2026

In Brief

A Phase 1 clinical trial evaluating PDA-002 for Peripheral Arterial Disease and Diabetic Foot Ulcer. Completed, enrolled 15 participants across 12 sites.

Signals

Enrollment appears stalled

Detailed Summary

This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and diabetic foot ulcers (DFU).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Diabetic Foot Ulcer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 21, 2013
Enrollment StartMay 23, 2013
Primary CompletionOct 1, 2016
Study CompletionMar 14, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.1 years ago

Arms & Interventions

3 x10^6 cellsexperimental

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.

Biological: PDA-002
10 x 10^6 cellsexperimental

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.

Biological: PDA-002
30 x 10^6 cellsexperimental

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.

Biological: PDA-002
100 x 10^6 cellsexperimental

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.

Biological: PDA-002

Interventions

PDA-002biological

Human placenta-derived cells administered intramuscularly on Study Days 1 and 8.