Pluristem Receives Clearance from Germany to Initiate Its Multinational Phase III Trial in Critical Limb Ischemia Targeting Early Conditional Marketing Approval
Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that Germany's health regulatory agency, the Paul Ehrlich Institute (PEI), has cleared Pluristem to begin enrollment in Germany for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia (CLI) in patients who are unsuitable for revascularization. The trial was recently cleared by the United States' Food and Drug Administration (FDA) and the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA).
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