Israel’s Pluristem has been granted clinical approval to begin trials on a placental-derived adherent stromal cell product, PLX-PAD, for the treatment of critical limb ischemia, the end stage of peripheral artery disease (PAD).
The Clinical Trial Application (CTA) was approved by the Paul Ehrlich Institute, the German competent authority in the EU.
Pluristem chairman, president and CEO Zami Aberman said that this would be the first allogenic stem cell product up for administration in Germany.
“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,” Aberman said.
Pluristem has also received approval from the Ethics Committee and the US Food and Drug Administration to initiate a similar trial in the US. Approval of the CTA and the US Investigational New Drug Application will clear the way for the world’s first in-man clinical trial using PLX-PAD.
