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Pluristem Reports On The Progress Of Its Phase I/II Clinical Trial For The Treatment Of Muscle Injury

Stocks in this article: PSTI

HAIFA, Israel, March 20, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today reported on the progress of its ongoing double blind Phase I/II clinical trial to test the safety and efficacy of its PLacental Expanded (PLX) cells in the treatment of muscle injury. This is the first time PLX cells have been used in patients following surgically induced muscle trauma.

The study is being conducted at the Orthopedic Clinic on the campus of the Charité University Medical School in Berlin, Germany. The muscle injury being studied is the gluteal buttock muscle that has been surgically traumatized during hip replacement surgery. The primary endpoint of the study is safety with a secondary endpoint of gluteal muscle function at 6 months with the ability to perform biopsies of the involved muscle. PLX cells will be injected directly into the surgical incision after it has been sutured. Three groups of six patients will be enrolled in the study. From each group of six patients, two patients will receive a high dose of PLX cells, two patients will receive a low dose of PLX cells and two patients will receive placebo. The first group of six patients has been dosed without a significant adverse event related to either the placebo or the PLX cell product candidate.

"We are very pleased with the progress of enrollment in this trial to date," stated Zami Aberman, Chairman and CEO of Pluristem. "This is the first time PLX cells have been used in addressing surgically induced muscle injury and a positive response will give us an indication of the potential of PLX cells for this indication as well as non-surgical injuries such as sports injuries."

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are 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 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.

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