FDA and the Paul Ehrlich Institute (Germany) Approve Pluristem Therapeutics’s Regulatory Submissions in Support of a Phase I/II Clinical Trial Utilizing PLX-PAD for Peripheral Artery Disease

NEW YORK--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NASDAQ:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that the Paul Ehrlich Institute (PEI) in Germany has approved the pre-clinical study synopsis to support a Phase I/II clinical trials in Germany and that the Center for Biologics Evaluation and Research (CBER), a division of the US Food and Drug Administration (FDA), has approved the synopsis to conduct a Phase I clinical trial in the US utilizing PLX-PAD for the treatment of limb ischemia associated with peripheral artery disease (PAD). The PEI is the German federal authority granting clinical trial approvals.
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