A Phase 2 Multi-center Randomized Double-Blind Placebo-Controlled Dose Range Finding Study to Evaluate the Safety Hemodynamic Effects and Efficacy of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects who have Diabetic Foot Ulcer with Peripheral Arterial Disease
Brief Description Of Study
This is a Phase 2, randomized, double-blind, placebo-controlled, dose range finding study in subjects who have DFU with PAD. The study will enroll approximately 24 subjects. Two dose levels of PDA-002 (3 x 106 and 30 x 106 cells) versus placebo will be evaluated in 1:1:1 randomization approach. Subjects will undergo a Screening/Run-In Period to determine study eligibility and initiate standard of care (Study Day -35 to Day -7) (Section 6.1). Subjects will then enter a Pre- Treatment Period (Study Day -7 to Day 0) in which vascular assessments prior to dosing will be completed. The Screening/Run-In/Pre-Treatment Period will be at least 2 weeks. After the Pre- Treatment Period, subjects will be randomized to a treatment arm and will receive investigational product (IP) PDA-002 cells or placebo. In the case of bilateral limb ulcers, the treated limb will be the limb that has the lowest qualifying TcPO2 value or ABI/TBI for inclusion. During the Treatment Period subjects will receive IM injections of PDA-002 on Study Days 1, 29 and 57 and will be evaluated on Study Days 1, 16, 29, and 57. During the Follow-up Period, subjects will be evaluated at Months 3, 4, 5, 6 and 12. All subjects are to receive standard treatment for DFU while receiving IP or placebo and throughout the study. An external data monitoring committee (DMC) will be convened to review interim efficacy and safety data when approximately 25% and 50% of subjects complete the Month 3 (Visit 7) assessment. Study enrollment will be ongoing during these scheduled reviews.