Pluristem Initiates Phase-I CLI Trial

Pluristem has enrolled the first patient in a phase-I clinical trial of allogeneic placental-derived adherent stromal cell product, termed as PLX-PAD. PLX-PAD is to be used in patients afflicted with critical limb ischemia (CLI).

The first patient was enrolled at the Franziskus-Krankenhaus Hospital, Berlin. The initiation of this study follows the recent approval of the company’s Clinical Trial Application (CTA) to begin clinical trials with PLX-PAD. The approval was granted by the Paul Ehrlich Institute (PEI), the German competent authority in the EU.

The phase-I study is designed to evaluate the safety of PLX-PAD in patients with CLI.

Zami Aberman, Chairman, President and CEO, Pluristem, said: We are proud to begin clinical trials with PLX-PAD, a cellular therapeutic product derived from the placenta, the organ intimately involved in the miracle of birth and a ubiquitous source of adult stromal cells that are easily obtained without harm to the mother or baby.