Company Explores Potential Off-the-Shelf Product for Muscle and Tendon Regeneration

Pluristem Therapeutics Inc., an Israel-based developer of placenta-based cell therapies, will pursue rotator cuff repair as the second indication in its orthopedic clinical program. The company’s 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, according to company officials.

There are currently no U.S. Food and Drug Administration-approved therapies using engineered cells for the treatment of rotator cuff injuries.

In January, Pluristem announced positive results from its Phase I/II clinical trial for the treatment of injured gluteal muscle after total hip arthroplasty. In addition, company officials also reported earlier this year strong preclinical data from studies of cells in the treatment of tendon injuries.

“This is a great result for a long path from a first idea to such a success in a first-in-men study in orthopedics with an off-the-shelf product to allow muscle regeneration,” said Dr. Georg Duda, M.D., the director of the Julius Wolff Institute and Berlin-Brandenburg Center for Regenerative Therapies at the Charité in Berlin, Germany.

“This is the first hope for muscle regeneration with virtually no clinical therapy presently available to treat injuries or defects in shoulder or lower leg muscles.” added Carsten Perka, M.D., head of orthopedics at the Center for Musculoskeletal Surgery at the Charité.

According to the American Academy of Orthopaedic Surgeons, nearly 2 million patients in the United States seek help for their rotator cuff injuries. The incidence of such injuries increases with age, so as the U.S. population ages the prevalence and potential cost burden is likely to grow.

“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,” said Pluristem’s CEO Zami Aberman.

There is a clear and unmet need for a new kind of therapy that can improve the outcome of orthopedic surgery for rotator cuff tears, according to Aberman.

“Our PLX cells can be administered as a simple office procedure,” noting that the company’s panel of experts has advised the company about the market viability of a non-invasive, effective cell therapy for orthopedic indications, added Aberman.

Pluristem’s patented PLX cells are a dilivered through a drug-delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3-D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.