A New Hope for Patients with Diabetic Foot Ulcers and Peripheral Artery Disease
Do you or someone you know struggle with the healing of diabetic foot ulcers?
The presence of peripheral artery disease (PAD) can make this condition even more challenging to treat. Celularity Inc. has announced encouraging results from a Phase 2 clinical trial of its investigational cell therapy, PDA-002, offering a potential new treatment for this difficult condition [1].
Key Findings from the Clinical Trial
The study, published in the International Wound Journal, involved 159 adult patients with chronic diabetic foot ulcers. The trial evaluated the safety and efficacy of PDA-002, a placenta-derived cell therapy. Patients received two intramuscular doses of PDA-002 at different dosage levels or a placebo.
Efficacy in Patients with PAD
The most significant results were seen in patients with PAD. The lowest dose of PDA-002 (3 × 10⁶ cells) led to complete wound closure in 38.5% of patients, compared to 22.6% in the placebo group.
This demonstrates a meaningful improvement in healing for this high-risk population.
| Treatment Group | Complete Wound Closure Rate |
|---|---|
| PDA-002 (3 × 10⁶ cells) | 38.5% |
| Placebo | 22.6% |
Safety and Other Benefits
PDA-002 was well-tolerated by patients, with no serious side effects linked to the treatment. The study also observed faster and more sustained healing in treated patients, along with fewer cases of new gangrene and foot infections compared to the placebo group.
How PDA-002 Works
PDA-002 is a mesenchymal stromal-like cell therapy derived from the postpartum placenta. These cells have potent angiogenic, immunomodulatory, and tissue-repair properties.
These properties may help to restore blood flow and promote healing in chronic wounds.
Expert Commentary
“Our data show that our investigational therapy, PDA-002, a placenta-derived, mesenchymal stromal-like cell therapy, can drive meaningful wound closure rates, reduce serious complications, and do so with a favorable safety profile,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO [1].
Market Impact and Future Outlook
Diabetic foot ulcers affect approximately two million people in the United States each year, with about half of them also having PAD. Currently, there are no FDA-approved therapies specifically for DFU with PAD. The annual economic burden of treating DFU in the U.S. exceeds $9 billion.
Celularity plans to move forward with a confirmatory Phase 3 trial. The goal is to deliver the first FDA-approved targeted therapy for DFU/PAD patients.
The company is also exploring the potential of PDA-002 for other conditions where microvascular disease is a factor.
About Celularity
Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company. It focuses on developing therapies from the postpartum placenta to address age-related and degenerative diseases.
References
[1] Celularity Inc. (2025, October 14). 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. GlobeNewswire. Retrieved from https://www.globenewswire.com/news-release/2025/10/14/3166225/0/en/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-Ulc.html
