Stem cell company Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today announced it is about to begin Phase II clinical trials in the US to evaluate the safety and efficacy of its PLacental Expanded (PLX) cells in the treatment of Intermittent Claudication (IC), a type of peripheral artery disease (PAD). The US Food and Drug Administration (FDA) granted clearance to start the Phase II clinical trial in April, and Pluristem, which develops placenta-based cell therapies, will commence the trials in the first week of September. Pluristem has already received Institutional Review Board (IRB) approval for the trial protocol for five out of the eleven US clinical site locations via its relationship with Western IRB, which has approved Pluristem's protocol. Site initiation will begin on September 5th at Duke University Medical Center with other sites becoming active in the following weeks following. Pluristem also plans to initiate trials in Europe and Israel in parallel to the eleven US sites. The study's lead principal investigator at Duke Dr. Manesh Patel said, "We are pleased to participate in the clinical trial process of this novel technology. Duke University Medical Center participated as a clinical site in Pluristem's Phase I/II trial using PLX-PAD cells … Continue reading
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