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

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.

Timeline

Start

2014-10-23

Primary completion

2018-02-27

Completion

2018-02-27

Outcome

Met primary endpoint

Stopped (Business): “The study was terminated early due to a business decision.”

paper within the peripheral artery disease subgroup (38.5% vs. 22.6% for placebo), meeting a stringent 4-week durability endpoint PMID 41077558 ↗

Publications

• Results Pollak R, Anderson J, Altmanshofer B, Caporusso J, Fantini G, Koppisetti S, Brigido S, Hariri R. Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomised, Double-Blind, Placebo-Controlled Trial. Int Wound J. 2025 Oct;22(10):e70769. doi: 10.1111/iwj.70769.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CENPLACEL-L	Cell therapy	3e+06 cells	Other
Subject	CENPLACEL-L	Cell therapy	1e+07 cells	Other
Subject	CENPLACEL-L	Cell therapy	3e+07 cells	Other

Indications