Pluristem Provides Update on Phase I/II Clinical Trial for the Treatment of Muscle Injury
Pluristem Therapeutics (NSDAQ: PSTI) today reported on the progress of its ongoing double blind Phase I/II clinical trial to test the safety and efficacy of its PLacental Expanded (PLX) cells in the treatment of muscle injury. This is the first time PLX cells have been used in patients following surgically induced muscle trauma.
The study is being conducted at the Orthopedic Clinic on the campus of the Charité University Medical School in Berlin, Germany. The muscle injury being studied is the gluteal buttock muscle that has been surgically traumatized during hip replacement surgery. The primary endpoint of the study is safety with a secondary endpoint of gluteal muscle function at 6 months with the ability to perform biopsies of the involved muscle. PLX cells will be injected directly into the surgical incision after it has been sutured. Three groups of six patients will be enrolled in the study. From each group of six patients, two patients will receive a high dose of PLX cells, two patients will receive a low dose of PLX cells and two patients will receive placebo. The first group of