Pluristem Therapeutics has announced that the FDA has cleared the company’s investigational new drug application to initiate a Phase I clinical trial for the treatment of critical limb ischemia, the end stage of peripheral artery disease, using Pluristem’s PLX-PAD.
This is reported to be the world’s 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 an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients, said Pluristem.
In this Phase I dose ranging trial, to be conducted at multiple locations in the US, PLX-PAD will be administered to patients considered ‘late stage’ and defined as patients afflicted with critical limb ischemia that have not responded to traditional medical or surgical interventions.
Zami Aberman, chairman, president and CEO of Pluristem, said: We are excited the FDA has cleared our investigational new drug 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.