Pluristem Recieves European Approval For Clinical Trial Of PLX-PAD

Israel based Pluristem has announced that the Paul Ehrlich Institute (PEI), the German competent authority in the EU, has approved the Clinical Trial Application (CTA). EU has granted approval to the company to begin clinical trials with 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).

Earlier, Pluristem has received approval from the Ethics Committee and FDA to initiate a similar trial in the US. Both approvals of the CTA and IND clears the way for the world’s first-in-man clinical trial using PLX-PAD.

Zami Aberman, Chairman, President and CEO of Pluristem, said: “Administering the first allogeneic stem cell product in Germany, Pluristem will be using PLX-PAD, our first product candidate in our cell therapy pipeline. Additionally, should the clinical trials in the US and Europe prove successful, it will have been the first time adult stem cells, derived from placenta and grown using our proprietary technology, have been administered to humans safely.”