Summary:
In patients with diabetic foot ulcers, including those with peripheral artery disease, intramuscular human placenta-derived cells (PDA-002) at doses of 3 × 10⁶, 10 × 10⁶, and 30 × 10⁶ cells significantly improved ulcer healing rates compared to placebo, though it was associated with mild to moderate adverse events including injection site reactions.
| PICO | Description |
|---|---|
| Population | Adults with diabetic foot ulcers, stratified by presence or absence of peripheral artery disease, enrolled in a Phase 2 multicenter trial. |
| Intervention | Intramuscular administration of human placenta-derived cells (PDA-002) at three dosing regimens: 3 × 10⁶, 10 × 10⁶, and 30 × 10⁶ cells. |
| Comparison | Placebo injections administered under identical conditions and schedule. |
| Outcome | PDA-002 treatment significantly increased rates of complete ulcer closure and accelerated healing time compared to placebo. Treatment was generally well-tolerated, with mostly mild to moderate injection site reactions as the main side effects. |
Source: Pollak, Richard, 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.
