Moving right along....
Pluristem to Initiate a Phase I/II Clinical Trial in Muscle Injury
Product Candidate Targets Orthopedic and Sports Injuries, Addresses a Multi-Billion Dollar Annual Market
HAIFA, Israel, Nov 14, 2012 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, 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 fur Orthopadie on the campus of the Charite 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.
Study Summary:
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 and time by using PLX cells over placebo. The endpoint of this study is to observe if there is an improvement in the functional recovery of the gluteal muscle as measured by maximal contraction force.
This randomized, double blinded, Phase I/II trial will evaluate the safety and efficacy of two doses of PLX cells versus placebo administered via intramuscular injections directly into the site of the lacerated gluteal muscle before suturing. The study cohort is comprised of approximately 18 patients equally divided between a high and low dose PLX cell group and placebo group. |
