Pluristem Therapeutics Inc. (PSTI) recently finished patient enrollment for a phase I/II trial being conducted in Germany.
The randomized, double-blinded, placebo controlled trial is being conducted to assess the safety and efficacy of the company’s PLacental Expanded (PLX) cells for the treatment of traumatized muscles.
The primary endpoint of the phase I/II study is to assess the safety and efficacy of PLX-PAD cells in evaluating the rehabilitation of the muscle activity of patients six months post treatment.
We note that Pluristem develops placenta-based cell therapies in collaboration with companies like United Therapeutics (UTHR) or through research and clinical institutions.
The cells from placenta are derived using the company's proprietary PluriX therapy. PLX-PAD, Pluristem's first candidate in development, is being developed for the treatment of peripheral artery disease (:PAD).
Meanwhile, the company is also evaluating PLX-PAD for the treatment of Intermittent Claudication (:IC) and Buerger's disease.
However, we remind investors that the US Food and Drug Administration (:FDA) has placed a clinical hold on a phase II IC study following a serious allergic reaction in one of the patients who required subsequent hospitalization.
As the study is being conducted both in the US and Germany, Pluristem informed the Paul-Ehrlich-Institute (PEI) in Germany about the clinical hold by the FDA and provided relevant information. Consequently, the IC study in Germany has also been put on hold.
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