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Celularity Inc. (NASDAQ:CELU) ("Celularity"), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today announced the publication of its Phase 2 study 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," in the International Wound Journal. Results of this study demonstrated safety and efficacy in a complex type of serious wounds in the setting of diabetes and peripheral vascular disease. Celularity's Chairman and CEO, Robert J. Hariri, M.D., Ph.D., also commented on PDA-002 as a stem cell therapy which qualifies under a recently enacted Florida law expanding access in the state to stem cell therapies not yet approved by the U.S. Food and Drug Administration.
Approximately two million individuals in the United States are affected each year by diabetic foot ulcers (DFU), nearly half of whom have coexisting peripheral artery disease (PAD). DFU complicated by PAD represents one of the most difficult and costly challenges in wound care. Currently, there are no U.S. Food and Drug Administration (FDA)-approved therapies specifically indicated for DFU with PAD. The estimated annual economic burden of treating DFU alone exceeds $9 billion in the United States. The presence of PAD significantly compromises lower-extremity perfusion, leading to chronic tissue ischemia, impaired angiogenesis, and delayed wound repair. PAD-associated DFUs are further characterized by persistent inflammation, altered immune response, and diminished responsiveness to standard wound care interventions. Despite five FDA-approved DFU therapies, none are currently approved for DFU complicated by PAD, underscoring the need for novel regenerative approaches that restore tissue perfusion and accelerate wound closure.
The published study included 159 adult patients with chronic diabetic foot ulcers (both with and without PAD) and was conducted across 35 clinical sites in the United States. Participants received two intramuscular doses of either PDA-002, a placenta-derived cell therapy developed by Celularity, 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—a more rigorous measure of durability than the standard FDA definition, which requires only two weeks of durable healing.
In patients with PAD, the highest rates of wound closure were observed with the lowest PDA-002 dose (3 × 10⁶ cells), where 38.5% of ulcers completely healed versus 22.6% in 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, using only two doses and no retreatment.
Posted In: CELU
