Pluristem Therapeutics Inc. announced the first patient enrollment in its Phase I clinical trial of PLX-PAD at Franziskus-Krankenhaus Hospital, Berlin. The PLX-PAD is used to treat patients with critical limb ischemia (CLI). The initiation of this study follows the recent approval of the company’s Clinical Trial Application (CTA) to begin clinical trials with PLX-PAD by the Paul Ehrlich Institute (PEI), the German competent authority in the European Union. Safety of PLX-PAD in patients with CLI will be evaluated in Phase I study. The trial includes up to fifteen adults with the disease. The trial is being conducted at the Franziskus-Krankenhaus Hospital and Charité –Universitätsmedizin Hospital, Berlin.
Zami Aberman, Chairman, President and CEO of Pluristem stated, “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. Additionally, our proprietary three-dimensional mass manufacturing technology allows us to grow cells significantly more efficiently and cost-effectively than cells grown via the labor intensive two-dimensional method which is the industry norm.