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

Rhea-AI Summary

Celularity (Nasdaq: CELU) announced peer-reviewed publication of its Phase 2 trial of PDA-002, a placenta-derived cell therapy for diabetic foot ulcers (DFU) with and without peripheral artery disease (PAD), in the International Wound Journal on October 14, 2025.

The multi-center, randomized, double-blind trial enrolled 159 patients across 35 US sites. Patients received two intramuscular doses (3×10^6, 10×10^6, or 30×10^6 cells) or placebo. In the PAD subgroup, the 3×10^6 dose achieved 38.5% complete wound closure versus 22.6% for placebo. PDA-002 showed faster, more sustained healing, fewer new gangrene and foot infections, and no serious treatment-related safety signals through two years.

Positive

• 38.5% wound closure in PAD at 3×10^6 cell dose
• Study enrolled 159 patients across 35 US sites
• Faster and more sustained healing versus placebo reported
• No serious treatment-related adverse events through two years

Negative

• Placebo wound closure in PAD was 22.6%, narrowing absolute gap
• Highest efficacy observed at lowest dose, unclear dose-response
• Results from Phase 2; a confirmatory Phase 3 trial is required

Insights

Clinical Trial and Regulatory Strategist

Phase 2 peer-reviewed results show PDA-002 safety and durable efficacy in DFU patients with PAD, supporting a Phase 3 pathway.

What happened: A randomized, double-blind Phase 2 trial of PDA-002 enrolled 159 adult patients across 35 U.S. sites and tested three dose levels versus placebo with two intramuscular doses. The primary endpoint required complete wound closure within three months plus four weeks of intact healing. In the PAD subgroup, the lowest dose (3×10^6 cells) achieved 38.5% closure versus 22.6% for placebo, with faster, more sustained healing and fewer new gangrene and infection events. Safety was favorable through two years of follow-up.

Dependencies and risks: Results are limited to a Phase 2 cohort and a subgroup finding by dose; durability was measured more stringently than the FDA standard but regulatory acceptance of the endpoint must be confirmed. The therapy currently qualifies under a Florida statute effective July 1, 2025, which affects local access but does not equal FDA approval. Key risks remain confirmatory trial design, reproducibility across doses, and regulatory acceptance of endpoints.

Concrete items to watch (near-term): publication in a peer-reviewed journal already occurred on Oct 14, 2025, planned confirmatory Phase 3 trial initiation and its chosen primary endpoint, and any regulatory interactions with the FDA regarding endpoint acceptability and label population. Also monitor longer-term safety and subgroup consistency over the next 12–24 months.

• First-in-class regenerative therapy for diabetic foot ulcers complicated by peripheral artery disease
  
• Celularity PDA-002 achieved durable wound healing with just two intramuscular doses
  
• As a qualified stem cell therapy under Florida statute (§ 458.3245), effective July 1, 2025 authorizing use in wound care, orthopedics, and pain management, PDA-002 may offer licensed Florida physicians an important new tool in treating DFU patients.
  

FLORHAM PARK, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) -- 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.

"The publication of our PDA-002 Phase 2 results in the International Wound Journal is a significant milestone for Celularity, and importantly, for patients battling diabetic foot ulcers complicated by peripheral artery disease, which is a patient population with a critical unmet medical need and limited treatment options,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO. “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. We believe PDA-002 has potential to transform the future of ischemic wound care, and these findings position us for a confirmatory Phase 3 trial aimed at delivering the first FDA-approved targeted therapy in regenerative wound care for DFU/PAD patients with this urgent and unmet need. We also believe these clinical results support additional development in clinical indications where underlying microvascular disease is a contributing factor.”

Commenting on recent developments, Dr. Hariri said, “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.” Diabetes afflicts an estimated 2.1 million Floridians according to a January 2025 Florida Diabetes Advisory Council report, which found that the percentage of adult Floridians diagnosed with diabetes grew by almost half since 2002 and is now above the national average (12.2% versus 11.6%). That percentage jumps to 25.4% among Floridians ages 65 and older, or some 1.25 million people, a fifth to a third of whom will go on to develop a DFU, for which the 5-year recurrence rate is 65%. “By unleashing promising stem cell therapies like PDA-002, Florida has given physicians a potentially important new tool for the treatment of diabetic foot ulcers, a serious condition that afflicts over a quarter of a million Floridians ages 65 and older,” said Dr. Hariri.

About PDA-002

PDA-002 is a mesenchymal stromal-like cell therapy product derived from the postpartum placenta. These cells possess potent angiogenic, immunomodulatory, and tissue-repair properties, offering a novel approach to wound healing in patients for whom current therapies are inadequate.

About Celularity Inc.

Celularity Inc. (Nasdaq: CELU) is a regenerative and aging-related cellular medicine company developing, manufacturing, and commercializing advanced biomaterial products and allogeneic and autologous cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies targeting fundamental aging mechanisms, such as cellular senescence, age-related chronic inflammation, and tissue degeneration. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com.

Forward Looking Statements

Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products, including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “improving,” “may,” “observed,” “potential,” “promise,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances, or otherwise, except as otherwise required by law.

Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com
(908) 845-4181

FAQ

What did Celularity announce about PDA-002 on October 14, 2025 (CELU)?

Celularity published Phase 2 results showing PDA-002 safety and efficacy for DFU with and without PAD, reported in the International Wound Journal.

How many patients and sites were in the PDA-002 Phase 2 trial (CELU)?

The randomized Phase 2 trial enrolled 159 patients across 35 US sites.

What were the PDA-002 dosing levels and regimen in the CELU Phase 2 study?

Patients received two intramuscular doses of PDA-002 at 3×10^6, 10×10^6, or 30×10^6 cells, or placebo.

What was the complete wound closure rate for PAD patients treated with PDA-002 (CELU)?

In the PAD subgroup, the 3×10^6 dose achieved 38.5% complete wound closure versus 22.6% for placebo.

Were there safety concerns reported for PDA-002 in the Phase 2 study (CELU)?

PDA-002 was reported as well tolerated with no serious treatment-related adverse events through two years of follow-up.

Does the Phase 2 publication mean PDA-002 is FDA-approved (CELU)?

No; results are from a Phase 2 trial and Celularity states a confirmatory Phase 3 trial is planned to seek FDA approval.

How does Florida law affect potential use of PDA-002 (CELU)?

Celularity noted PDA-002 qualifies under a July 1, 2025 Florida statute allowing certain stem cell therapies to be used by licensed physicians in wound care, orthopedics, and pain management.