Summary: In a phase 2 trial, intramuscular placenta-derived cells (PDA-002) for diabetic foot ulcers showed their highest healing rate at the lowest dose and specifically in the subgroup with peripheral artery disease, rather than a uniform benefit across all doses.
PICO Summary
| Element | Detail |
|---|---|
| Population | 159 adults with chronic diabetic foot ulcers, stratified by peripheral artery disease status; phase 2 multicentre, double-blind RCT, USA. |
| Intervention | Intramuscular PDA-002 (mesenchymal stromal-like placental cells) at 3×10⁶, 10×10⁶, or 30×10⁶ cells. |
| Comparison | Placebo. |
| Outcome | PDA-002 was well tolerated with no treatment-related serious adverse events. The highest efficacy was at the lowest 3×10⁶ dose within the peripheral-artery-disease subgroup (38.5% complete closure vs 22.6% for placebo), meeting a stringent 4-week durability endpoint. The benefit was therefore dose- and subgroup-specific rather than uniform. |
PDA-002 for diabetic foot ulcers
Phase 2 RCT · DFU · PAD subgroup
In the peripheral-artery-disease subgroup, the lowest PDA-002 dose achieved complete ulcer closure in 38.5% versus 22.6% with placebo, with good tolerability. A dose- and subgroup-specific phase 2 signal that needs phase 3 confirmation.
Expert Commentary
This is an early-phase cell-therapy trial that should be read for signals rather than conclusions, and with care not to overstate it. The promising element is genuinely interesting: the most challenging ulcers, those complicated by peripheral artery disease, showed the clearest benefit, consistent with a treatment whose proposed mechanism is angiogenic and tissue-regenerative and therefore most useful where perfusion is the limiting problem. But the pattern matters and resists a simple it works summary. Efficacy concentrated at the lowest of three doses and within one prespecified subgroup, which is biologically plausible for cell therapies that can show non-linear dosing, yet a low-dose, single-subgroup phase 2 result is hypothesis-generating and demands confirmation before any clinical reliance. Reassuringly, tolerability was good with no treatment-related serious adverse events, and meeting a four-week durability endpoint stricter than the regulatory minimum is a point in its favour. Can I use this with my patients? Not yet. This is investigational and not available for routine use, and even as proof of concept it does not displace the fundamentals of offloading, debridement, infection control, and revascularisation for ulcers with arterial disease. I would watch for the phase 3 programme that a subgroup signal like this should prompt.
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