Placenta-derived cell therapy shows promise in patients with peripheral artery disease “Celularity announced that its Phase 2 trial of PDA-002, a human placenta-derived cell therapy, has been published in the International Wound Journal. The company claims the published data demonstrate both safety and efficacy in treating diabetic foot ulcers (DFU), particularly in patients with coexisting peripheral artery disease (PAD).
The randomized, double-blind, placebo-controlled study enrolled 159 adult patients with chronic DFU, conducted across 35 U.S. sites. Participants received two intramuscular doses of PDA-002 at one of three cell dose levels (3 × 10⁶, 10 × 10⁶, or 30 × 10⁶ cells) or placebo. The primary endpoint was complete ulcer closure within three months, sustained for at least four additional weeks.
In the PAD subgroup, the lowest dose (3 × 10⁶ cells) achieved full wound closure in 38.5% of patients versus 22.6% in the placebo arm. The company reports that treated patients experienced faster, more durable healing, and fewer incidences of new gangrene or foot infections. Across all dose groups, PDA-002 was well tolerated and no serious treatment-related adverse events were observed over two years of follow-up.
Celularity noted that currently there are no FDA-approved therapies specifically for DFU complicated by PAD. The company said it plans to advance PDA-002 into a confirmatory Phase 3 trial. The press release also highlights that PDA-002 qualifies as a stem cell therapy under a new Florida statute, potentially expanding access in that state.”
