Phase II Trial in Intermittent Claudication
Pluristem is conducting a multinational, randomized, double blind, placebo controlled Phase II trial of PLX-PAD in Intermittent Claudication (IC). Enrollment is ongoing in the U.S., Germany, Israel, and South Korea, with a recruitment goal of 170 participants. Patients are being randomized to receive either two courses of 150 ×106 PLX-PAD cells, two courses of 300 ×106 cells, two courses of placebo, or one course of 300 ×106 PLX‑PAD cells followed by placebo. In each of these study arms, the two courses are given intramuscularly, 3 months apart. The primary efficacy endpoint is the change in maximal walking distance one year after the first administration. Other endpoints include the change in initial claudication distance, hemodynamic parameters (ankle-brachial index, toe-brachial index), quality of life score, and the rate of revascularization.