Phase II Trial in Intermittent Claudication
Pluristem completed a multinational, randomized, double blind, placebo controlled Phase II trial (n=172) of PLX-PAD in Intermittent Claudication (IC), in the U.S., Germany, Israel, and South Korea. Patients received 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 were 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.
Study recruitment is completed. Data is expected during Q2/2018.
Proposed Mechanism of Action (MOA) for Peripheral Artery Disease (PAD):
More about the Mechanism of Action is available here.