Pluristem Completes Enrollment for Phase I/II Muscle Injury Trial
Study Conducted in Germany Marks the First Time PLX-PAD Cells are Used for the Treatment of Surgically Induced Muscle Trauma
HAIFA, Israel, Jul 11, 2013 (GLOBE NEWSWIRE via COMTEX) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, 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 Charite 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 therapy (Reference: clinicaltrials.gov.
"Having treated all patients in this trial, we have reached a milestone. The ease of use of our allogeneic, off-the-shelf product enabled us to complete recruitment quickly and efficiently. Following completion of the follow up period, we will obtain data on the safety and efficacy of PLX-PAD cells in the treatment of traumatized muscles during hip replacement surgery" stated Zami Aberman, Chairman and CEO of Pluristem. "This trial is important as it marks the first time PLX-PAD cells have been used in patients following surgically induced muscle trauma. It also provides data on the potential use of PLX cells for the treatment of sports related injuries." |
