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Pluristem's Phase I/II Muscle Injury Trial Meets Primary Safety & Efficacy Endpoints

Pluristem Therapeutics (Nasdaq: PSTI) today announced top-line results from its Phase I/II clinical trial testing the safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury. The trial indicated PLX-PAD cells were safe and statistical significance was reached (p=0.0067) for the primary efficacy endpoint of the study, the change in maximal voluntary isometric contraction force of the gluteal muscle at six months after total hip replacement. Patients treated with PLX-PAD had a greater improved change of maximal voluntary muscle contraction force than the placebo group. These results provide evidence that PLX cells may be efficacious in the treatment of orthopedic injuries including muscles and tendons.

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Posted-In: News Guidance FDA Management Global

 

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