Pluristem to Initiate Phase I/II Muscle Injury Clinical Trial
Pluristem Therapeutics (NASDAQ: PSTI) today announced it has initiated a Phase I/II clinical trial to evaluate the safety and efficacy of its PLacental Expanded (PLX) cells in the treatment of muscle injury. As previously reported, the Paul Ehrlich Institute (PEI), the German competent authority in the European Union, has granted the Company clearance to start the trial which will be conducted at the Klinik für Orthopadie on the campus of the Charité Universitatsmedizin in Berlin, Germany.
"Pluristem considers this clinical trial to be our entry into the orthopedic and sports medicine markets. The response of the gluteal muscle to our PLX cells will be an indication for us of how well our cells would help various muscle injuries," stated Zami Aberman, Chairman and CEO of Pluristem.
In this Phase I/II trial, the muscle injury studied will be the trauma sustained to the gluteal buttock muscle that occurs during hip replacement. The most common type of hip replacement surgery involves splitting the gluteal muscle to obtain access to the hip joint. Previous muscle injury animal studies have demonstrated a significant improvement in rehabilitation function