Summary:
In patients with diabetic foot ulcers, particularly those with peripheral artery disease, intramuscular human placenta-derived cells (PDA-002) significantly increased the rate of complete and sustained wound closure compared to placebo across three dose groups, with the highest efficacy seen at the 3 × 106 cell dose, though it was associated with no treatment-related serious adverse events.
| PICO | Description |
|---|---|
| Population | Adults with chronic diabetic foot ulcers, stratified by presence or absence of peripheral artery disease. |
| Intervention | Intramuscular injection of human placenta-derived stromal-like cells (PDA-002) administered at doses of 3 × 106, 10 × 106, and 30 × 106 cells. |
| Comparison | Placebo treatment given under similar conditions as the active intervention arms. |
| Outcome | The primary endpoint—complete wound closure within 3 months sustained for an additional 4 weeks—was most effectively achieved with the 3 × 106 cell dose in patients with peripheral artery disease (38.5% vs. 22.6% placebo). PDA-002 was well-tolerated with no treatment-related serious adverse events. |
Source: Richard Pollak, 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.” Read article here.
