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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 afflicted with CLI that have not responded to traditional medical or surgical interventions.

Zami Aberman, Chairman, President and CEO of Pluriste, commented, “We are excited the FDA has cleared our IND application for our PLX-PAD product so quickly. PLX-PAD is our first product candidate in our PLX pipeline and this clinical trial will be the first time a placenta-derived stem cell product, grown using our 3D expansion technology, will be used in humans.”

He added, “Our PLX cells are an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients. We believe this unique approach can provide patients with an affordable, immediate source of cell therapy and will position Pluristem as a leader in the cell therapy field.”

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