Celularity Inc. (Nasdaq: CELU) announced today the publication of its Phase 2 study, “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 on 14 October 2025. The study evaluated the safety and efficacy of PDA‑002, a placenta‑derived mesenchymal‑stroma‑like cell therapy, in patients with chronic diabetic foot ulcers (DFUs) complicated by peripheral artery disease (PAD).
The randomized, double‑blind trial enrolled 159 adult patients across 35 U.S. clinical sites. Participants received two intramuscular doses of PDA‑002 at one of three dosage levels—3 × 10⁶, 10 × 10⁶, or 30 × 10⁶ cells—or placebo. The primary endpoint was the proportion of patients achieving complete wound closure within three months, with durability defined as intact healing for at least four additional weeks. In the PAD subgroup, the lowest dose (3 × 10⁶ cells) produced a 38.5 % closure rate versus 22.6 % in the placebo group, while higher doses showed comparable or slightly lower efficacy.
Safety data from the trial were favorable. PDA‑002 was well tolerated across all dosage levels, with no serious adverse events attributable to the therapy. Follow‑up through two years confirmed the durability of the safety profile, with no new safety signals emerging. The study’s robust safety and efficacy outcomes support the therapeutic potential of PDA‑002 for a population with limited treatment options and a high economic burden.
The publication of these Phase 2 results marks a critical milestone for Celularity’s PDA‑002 program. The data provide a strong foundation for a confirmatory Phase 3 trial aimed at obtaining FDA approval for a first‑in‑class therapy for DFUs complicated by PAD. Additionally, the therapy qualifies under Florida’s recently enacted law that permits physicians to use investigational stem cell treatments, opening a potential market for early access and commercial deployment in that state. The study’s outcomes therefore enhance Celularity’s pipeline prospects and could accelerate the company’s path to regulatory approval and market entry.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.