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NCT02264288 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.

A Phase 2 study, sponsored by Celularity Incorporated.

Terminated
Registry status
Phase 2
Development phase
159
Enrollment target

NCT02264288: Clinical Trial Phase 2 study, sponsored by Celularity Incorporated.

NCT02264288 is a Phase 2 study that was terminated before completion, run by Celularity Incorporated. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02264288, a Phase 2 study, was terminated before completion, sponsored by Celularity Incorporated.

TERMINATED
Registry status
Phase 2
Development phase
159 participants
Enrollment target

Study Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with diabetic foot ulcers (DFU), including subjects with and without peripheral arterial disease (PAD). Subjects were randomized to receive one of three dose levels of PDA-002 or placebo. Randomization was stratified by PAD status. The study evaluated wound healing and safety outcomes over the follow-up period.

Primary Outcome

Complete wound closure is defined as closure of the index ulcer within 3 months after dosing and retaining wound closure for the subsequent 4 weeks.

Interventions

  • OTHER Placebo
  • BIOLOGICAL PDA-002

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2014-10-23
Est. Completion 2018-02-27
Phase Phase 2
Celularity Incorporated

14 total trials

Why NCT02264288 stopped before completion

NCT02264288 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02264288 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02264288 about?

NCT02264288 is a clinical study titled "Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.". This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with diabetic foot ulcers (DFU), including subjects with and without peripheral ar...

What is the current status of trial NCT02264288?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2014-10-23. Estimated completion is 2018-02-27.

What interventions are being tested in trial NCT02264288?

The interventions under investigation include: Placebo (OTHER), PDA-002 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02264288?

This trial is sponsored by Celularity Incorporated, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02264288's enrollment target sits among peer trials

159 442nd of 2000 higher than 1,558 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02264288, the US trial registry maintained by the National Library of Medicine. NCT02264288 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.