Unlocking the Secrets of Cell Death: Researchers Explore 'Death Fold' Proteins for Disease Treatment

Researchers are exploring "death fold" proteins to understand why some cells die too soon, such as in Alzheimer's, and why others don't die soon enough, such as in cancer. These proteins can trigger programmed cell death, a process essential for health. By studying immune cells that self-destruct, scientists hope to develop disease treatments that modify or modulate cell death.

Celularity Inc. (Nasdaq: CELU) recently announced the publication of its Phase 2 trial results for PDA-002, a placenta-derived cell therapy designed to treat diabetic foot ulcers (DFU) with and without peripheral artery disease (PAD). The trial, 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," was published in the International Wound Journal on October 14, 2025, according to a Celularity press release.

The trial enrolled 159 adult patients across 35 clinical sites in the United States. Participants received two intramuscular doses of either PDA-002 at one of three dosage levels (3 × 10⁶, 10 × 10⁶, or 30 × 10⁶ cells) 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.

In the PAD subgroup, the lowest dose (3 × 10⁶ cells) achieved 38.5% complete wound closure versus 22.6% for the placebo group. The data also showed faster and more sustained healing in treated patients, along with fewer cases of new gangrene and foot infections compared to those who received a placebo. Across all groups, PDA-002 was well tolerated, with no serious side effects linked to the treatment. This favorable safety profile remained consistent through two years of follow-up.

The study's findings highlight the regenerative and angiogenic potential of PDA-002 in promoting durable ulcer closure in patients with DFUs complicated by PAD. Celularity's Chairman and CEO, Robert J. Hariri, M.D., Ph.D., commented that these results support the company's plans to initiate a confirmatory Phase 3 trial aimed at delivering the first FDA-approved targeted therapy in regenerative wound care for DFU/PAD patients.

Additionally, Celularity is actively assessing opportunities to apply these findings in jurisdictions such as Florida, where PDA-002 qualifies as a stem cell therapy under a new law authorizing use by Florida physicians in wound care, orthopedics, and pain management. Florida has a significant population affected by diabetes, with an estimated 2.1 million Floridians diagnosed according to a January 2025 Florida Diabetes Advisory Council report.

References

- 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 — `https://www.stocktitan.net/news/CELU/celularity-announces-peer-reviewed-publication-of-phase-2-clinical-loe0s6swd62p.html`

- Florida Diabetes Advisory Council — `https://www.floridadiabetes.org/`