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

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).

Timeline

Start

2013-05-23

Primary completion

2016-10-01

Completion

2017-03-14

Publications

• Results Wu SC, Pollak R, Frykberg RG, Zhou W, Karnoub M, Jankovic V, Fischkoff SA, Chitkara D. Safety and efficacy of intramuscular human placenta-derived mesenchymal stromal-like cells (cenplacel [PDA-002]) in patients who have a diabetic foot ulcer with peripheral arterial disease. Int Wound J. 2017 Oct;14(5):823-829. doi: 10.1111/iwj.12715. Epub 2017 Jan 30.
• Francki A, Labazzo K, He S, Baum EZ, Abbot SE, Herzberg U, Hofgartner W, Hariri R; Celgene Cellular Therapeutics Research Group. Angiogenic properties of human placenta-derived adherent cells and efficacy in hindlimb ischemia. J Vasc Surg. 2016 Sep;64(3):746-756.e1. doi: 10.1016/j.jvs.2015.04.387. Epub 2015 Jun 6.

Drugs

Indications