Pluristem Therapeutics Inc. (PSTI) Granted FDA Clearance to Begin “First-In-Human” Placenta-Derived Stem Cell Clinical Trial
Pluristem Therapeutics Inc. announced that the US Food & Drug Administration (FDA) has given the company clearance to begin a Phase I clinical trial for the treatment of Critical Limb Ischemia (CLI), the end stage of peripheral artery disease (PAD), using Pluristem’s PLX-PAD. This will be the first clinical trial using PLX-PAD, Pluristem’s placenta-derived stem cells that are expanded using the company’s proprietary 3D PluriX™ technology. PLX-PAD is a unique one-size-fits-all product that doesn’t require tissue matching before being administered to patients. According to the press release, PLX-PAD will be administered to patients considered "late stage" and defined as patients…