Celularity announces publication of Phase 2 study on PDA-002

Celularity (CELU) announced the publication of its Phase 2 study titled “Human Placenta-Derived Cells, PDA-002, in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial,” in the International Wound Journal. Results of this study demonstrated safety and efficacy in a complex type of serious wounds in the setting of diabetes and peripheral vascular disease. Celularity’s Chairman and CEO, Robert J. Hariri, M.D., Ph.D., also commented on PDA-002 as a stem cell therapy which qualifies under a recently enacted Florida law expanding access in the state to stem cell therapies not yet approved by the U.S. Food and Drug Administration. The published study included 159 adult patients with chronic diabetic foot ulcers and was conducted across 35 clinical sites in the United States. Participants received two intramuscular doses of either PDA-002, a placenta-derived cell therapy developed by Celularity, at one of three dosage levels, or a placebo. The primary efficacy endpoint was the number of patients who achieved complete wound closure within three months with healing that remained intact for at least four additional weeks.