HAIFA, Israel, April 18, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today it is expanding its presence in the orthopedic and sports medicine markets with plans to initiate a Phase I clinical trial to evaluate the safety and efficacy of the local administration of PLX cells to patients suffering from injuries to tendons. This study planned will be a randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of local intra-tendon injections of PLX-PAD cells to patients suffering from rotator cuff tear requiring arthroscopic repair. The hypothesis is that PLX-PAD cells will improve the post-operative structural and functional status of the rotator cuff. This placebo controlled study will be conducted in approximately 30 patients with a follow-up period of 6 months.
Tendinosis, sometimes called chronic tendonitis, is an accumulation over time of micro tears of the connective tissue in and around the tendon that does not heal properly. Tendinosis leads to pain and a reduced range of motion. If left untreated, tendinosis may lead to reduced tensile strength that increases the chance of tendon rupture. Current therapies involve prolonged rest and immobilization. Rotator cuff tendinosis is a very common problem with more than 50% of individuals older than 60 years presenting with at least a partial-thickness rotator cuff tear. According to the American Academy of Orthopedic Surgeons, each year approximately 200,000 Americans require surgery related to repair of the rotator cuff. However full recovery after rotator cuff surgery often takes 4 to 6 months and approximately 65% of the patients undergoing rotator cuff repair will have a satisfactory result one year following surgery.
"We have preclinical data illustrating the potential efficacy of PLX cells in the treatment of tendon pathologies, conditions which impact a large segment of the population. Intra-tendon injections of PLX cells will potentially allow us to provide the focused delivery of therapeutic proteins in the treatment of tendon injuries. This trial represents the expansion of our orthopedic and sports injury franchise and is additive to our current ongoing study in muscle injury," stated Zami Aberman, Pluristem's Chairman and CEO.