Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease

Core Insights - Celularity Inc. announced the publication of its Phase 2 study on PDA-002, a placenta-derived cell therapy for diabetic foot ulcers (DFUs) complicated by peripheral artery disease (PAD), demonstrating safety and efficacy in treating serious wounds [1][6] - The study involved 159 adult patients and was conducted across 35 clinical sites in the U.S., showing that PDA-002 achieved higher rates of wound closure compared to placebo [3][4] Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, focusing on developing therapies derived from postpartum placenta to address age-related and degenerative diseases [10] - The company aims to provide effective, accessible, and affordable therapies targeting fundamental aging mechanisms [10] Study Details - The Phase 2 study included patients with chronic DFUs, with a primary efficacy endpoint of complete wound closure within three months, maintaining healing for at least four additional weeks [3] - PDA-002 was administered in three dosage levels (3×10⁶, 10×10⁶, or 30×10⁶ cells) or as a placebo, with the lowest dose showing the highest healing rates in patients with PAD [4] Economic Context - Approximately two million individuals in the U.S. are affected by DFUs annually, with an estimated economic burden of over $9 billion for treating DFUs alone [2] - There are currently no FDA-approved therapies specifically for DFUs complicated by PAD, highlighting the need for innovative treatments [2] Clinical Findings - In patients with PAD, 38.5% of ulcers healed completely with the lowest PDA-002 dose compared to 22.6% in the placebo group, indicating a significant improvement in healing rates [4] - PDA-002 demonstrated a favorable safety profile, with no serious side effects reported during the two-year follow-up [4][5] Future Implications - The positive results from the Phase 2 study position Celularity for a confirmatory Phase 3 trial, aiming to deliver the first FDA-approved targeted therapy for DFU/PAD patients [6] - The recent Florida law allows for expanded access to stem cell therapies like PDA-002, potentially providing new treatment options for patients in the state [7][8]