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Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers

NCT01859117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-06-04

Study results available
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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).

Conditions

  • Peripheral Arterial Disease
  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

PDA-002

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

Sponsors & Collaborators

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • sharmila koppisetti, MD · Celularity Incorporated

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-23
Primary Completion
2016-10-01
Completion
2017-03-14
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 NCT01859117 on ClinicalTrials.gov