Pluristem Announces Completion of Enrollment for Phase I/II Muscle Injury Trial
Pluristem Therapeutics (NASDAQ: PSTI) announced today it has completed the target enrollment in a randomized, double-blinded, placebo controlled Phase I/II clinical trial to assess the safety and efficacy of its PLacental Expanded (PLX) cells for the treatment of traumatized muscles. All patients have been treated with PLX-PAD cells or placebo and are currently in the follow up stage of the trial.
The study is being conducted at the Orthopedic Clinic on the campus of the Charité University Medical School in Berlin, Germany and is under the oversight of Germany's healthcare regulatory bodies, the Paul Ehrlich Institute (PEI) and Berlin's Ethic Committee, LaGeSo.
In this trial patients were injected with either PLX-PAD cells or placebo directly into their gluteal muscles that had been surgically traumatized during hip replacement surgery. The primary endpoint of the study is to assess the safety and efficacy of PLX-PAD cells in evaluating the rehabilitation of the muscle activity of the patient at six months following treatment. Secondary efficacy endpoints include Magnetic Resonance Imaging (MRI) and macroscopic and microscopic structure of the involved gluteal muscles from biopsies taken at three months post