A recent study by Children's Hospital Oakland suggests the placenta contains the same quality stem cells as cord blood but in much larger numbers. The primary problem with cord blood has been the relatively small harvest of stem cells for use in transplants.
Pluristem Therapeutics, one of our Sector Companies, specializes in therapies derived using placental derived stem cells. Now, 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.
Pluristem’s placental-derived stem cells 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. In these phase I trials, to be conducted at multiple locations in the US and Germany, PLX-PAD will be administered to patients considered "late stage" that have not responded to traditional medical or surgical interventions.
In the US alone, it is estimated that 8-12 million people suffer from critical limb ischemia associated with PAD. Several Sector Companies are researching and testing applications for critical limb ischemia.
Adapted from the Pluristem Therapeutics announcement.
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