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

NCT02264288 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2026-06-12

Study results available
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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.

Conditions

  • Peripheral Arterial Disease
  • Diabetic Foot

Interventions

BIOLOGICAL

PDA-002

Human placenta-derived cells administered intramuscularly on Study Days 1 and 8 at assigned dose levels.

OTHER

Placebo

Matching placebo administered intramuscularly on Study Days 1 and 8.

Sponsors & Collaborators

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • Sharmila Koppisetti, MD · Celularity Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-23
Primary Completion
2018-02-27
Completion
2018-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02264288 on ClinicalTrials.gov