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Pluristem (PSTI) Initiates A P1/2 Clinical Trial In Muscle Injury

Product Candidate Targets Orthopedic and Sports Injuries...

PSTI initiated a P1/2 clinical trial to evaluate the safety and efficacy of its PLacental Expanded (NYSEMKT:PLX) cells in the treatment of muscle injury. As previously reported, the Paul Ehrlich Institute (NYSE:PEI), the German competent authority in the European Union, has granted PSTI clearance to start the trial which will be conducted at the Klinik für Orthopadie on the campus of the Charité Universitatsmedizin in Berlin, Germany.

In this P1/2 trial, the muscle injury studied will be the trauma sustained to the gluteal buttock muscle that occurs during hip replacement. This randomized, double blinded, P1/2 trial will evaluate the safety and efficacy of 2 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.

The Bottom Line: 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. A very plausible application but, it will depend on trial design but, existing tissue products provide proof of concept. It could be a huge opportunity with a lot of interest in using cell therapy. Look at all the stuff used now with no data (eg: PRP). There are also … lots of applications: rotatory cuff, tennis elbow, plantar fasciitis, tendon repair, the list goes on -- weekend warriors will pay!

PSTI is trading down -$0.14 or -4.21 to $3.18 as many digest and connect the dots of the past few days uproar!

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.