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COMPLETED
NCT01859117
PHASE1

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

Sponsor: Celularity Incorporated

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2013-05-23

Completion Date

2017-03-14

Last Updated

2026-06-04

Healthy Volunteers

No

Interventions

BIOLOGICAL

PDA-002

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

Locations (12)

Carl T. Hayden Veterans Affairs Medical Center

Phoenix, Arizona, United States

UCLA

Los Angeles, California, United States

VA Palo Alto health

Palo Alto, California, United States

Dr. Wiliam M. Scholl College of Podiatric Medicine

North Chicago, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Vascular Surgeon

Minneapolis, Minnesota, United States

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Complete Family Foot Care - McAllen Office

McAllen, Texas, United States

Endeavor Clinical Trials PA

San Antonio, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States