Pluristem Therapeutics Receives European Regulatory Approval for Placental-Derived Stem Cell Clinical Trial

HAIFA, Israel--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the Paul Ehrlich Institute (PEI), the German competent authority in the European Union, has approved the Company’s Clinical Trial Application (CTA) and granted approval to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). In addition, Pluristem has already received approval from the Ethics Committee and, as previously announced, the US Food & Drug Administration (FDA) had cleared the Company’s Investigational New Drug (IND) application to initiate a similar trial in the United States. Both approvals of the CTA and IND clear the way for the world’s “first-in-man” clinical trial using PLX-PAD.

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