Summary: In adults with diabetic foot ulcers, intramuscular placenta-derived cells (PDA-002) improved sustained wound closure versus placebo, with the clearest signal (38.5% vs 22.6%) at the lowest dose in the peripheral artery disease subgroup, and no treatment-related serious adverse events.
PICO Summary
| Element | Detail |
|---|---|
| Population | 159 adults with chronic diabetic foot ulcers, stratified by peripheral artery disease status (phase 2, multicentre). |
| Intervention | Intramuscular human placenta-derived cells (PDA-002) at 3×10⁶, 10×10⁶, or 30×10⁶ cells. |
| Comparison | Placebo under matched conditions. |
| Outcome | Primary endpoint (complete closure within 3 months, sustained 4 weeks) highest at the 3×10⁶ dose in the PAD subgroup (38.5% vs 22.6% placebo). Well tolerated, no treatment-related serious adverse events. Dose response non-monotonic. |
Placenta-derived cells (PDA-002) for diabetic foot ulcers
RCT · diabetic foot ulcers · PAD subgroup
In the peripheral artery disease subgroup, the lowest PDA-002 dose raised sustained wound closure from 22.6% to 38.5% with no treatment-related serious adverse events. The benefit was confined to one subgroup at one dose with a non-monotonic dose response, so the finding is hypothesis-generating only.
Expert Commentary
The ischaemic diabetic foot ulcer is one of the most disheartening things I manage, because standard care so often fails when perfusion is poor, so any pro-angiogenic strategy aimed precisely at that group earns a careful look. The encouraging part is that the signal appeared where the need is greatest, in patients with peripheral artery disease. My verdict, though, is firmly preliminary, because almost everything about the positive result invites caution. The benefit lived in a subgroup at a single dose, and the dose response was non-monotonic, with the lowest dose working best, which is biologically awkward and exactly the pattern that sometimes signals chance rather than a true effect. Follow-up also captured four-week sustained closure but not the outcomes I care most about, recurrence, amputation, and limb salvage. Can I use this with my patients? No, not outside a trial. Standard care, debridement, offloading, infection control, glucose, and vascular assessment, remains the foundation, and nothing here displaces it. I would welcome an adequately powered phase 3 trial in perfusion-limited ulcers before considering this adjunct.
References
Pollak R, Anderson J, Altmanshofer B, et al. Human placenta-derived cells (PDA-002) in diabetic foot ulcer patients with and without peripheral artery disease: a phase 2 multi-center, randomised, double-blind, placebo-controlled trial. Int Wound J. 2025;22(10):e70769. doi:10.1111/iwj.70769