Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers

The purpose of this Phase 1 study was to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of PDA-002, a human placenta-derived cell therapy, administered by intramuscular injection in subjects with peripheral arterial disease (PAD) and diabetic foot ulcers (DFU). This was a multicenter, open-label, 3+3 dose-escalation study. Subjects received PDA-002 administered intramuscularly on Study Days 1 and 8 at 1 of 4 planned dose levels ranging from 3 × 10\^6 to 100 × 10\^6 cells. Dose escalation proceeded after review of safety data from previously enrolled subjects. Subjects were followed for safety assessments for up to 24 months.