Pluristem Therapeutics Inc. has announced that it will be moving forward with rotator cuff repair as the second indication in its orthopedic program. The company indicates that its PLacental eXpanded (PLX) cells offer potential as the first off-the-shelf cell therapy product for muscle and tendon regeneration that can be used to enhance repair after rotator cuff surgery.
“Following the favorable results of our Phase I/II trial in our first orthopedic indication, the treatment of injured gluteal muscle after total hip replacement, we, together with key opinion leaders in orthopedic surgery, selected rotator cuff repair as an important indication in need of a novel cell therapy solution. We are progressing with our study design, and are considering the addition of a third orthopedic indication, ” stated Pluristem CEO Zami Aberman in the June 25, 2014 news release.
Asked about the key opinion leaders, Aberman indicated that the following individuals worked with the company: Shaul Beyth, M.D., Ph.D. of Hebrew University Medical School and Hadassah Medical Center, Jerusalem, Israel; Professor Andrew Carr, M.D. of University of Oxford; Professor Georg Duda, Ph.D. of Charite Hospital, University of Berlin; Thomas A. Einhorn, M.D. of Boston University; Ron Noy, M.D. of Prestige Orthopaedics & Sports Medicine in New York; Professor Carsten Perka, M.D. of Charite Hospital, University of Berlin; Scott Rodeo, M.D. of The Hospital for Special Surgery; Tobias Winkler, M.D., Ph.D. of Charite Hospital, University of Berlin.
As for these opinion leaders thoughts on this second indication (why this, why now), Aberman told OTW, “There are huge numbers of patients in the U.S. (two million) seeking treatment for rotator cuff injury, and there is a clear need to expand and improve treatment options for this condition. The incidence of these types of injuries increases with age, so as our population ages we are likely to see even greater need for treatments. Our PLX cells are designed to be an off-the-shelf therapy that can be administered as a simple office procedure. If a product is easy to use that could provide additional benefit to both patients and providers. We are eager to use the favorable data we collected in our Phase II muscle injury trial as a springboard to enter deeper into the orthopedic space. One year from now Pluristem hopes to be conducting a phase II clinical trial for this indication.”
