Pluristem's Phase I/II Muscle Injury Trial Meets Primary Endpoints - Quick Facts

(RTTNews) - Pluristem Therapeutics Inc. (PSTI), a developer of placenta-based cell therapies, reported top-line results from its Phase I/II study testing the safety and efficacy of PLacental eXpanded or PLX-PAD cells in the muscle injury treatment. The trial indicated that the PLX-PAD cells were safe and statistical significance was reached for the primary efficacy endpoint of the trial, 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 treating orthopedic injuries, including muscles and tendons.

The Phase I/II trial was a randomized, placebo-controlled, double-blinded study conducted at the Orthopedic Clinic of the Charité University Medical School under the auspices of the Paul-Ehrlich-Institute, Germany's health authority. The 20 patients in the study were randomized into three treatment groups, with one group treated with 150 million PLX-PAD cells per dose, the second administered with 300 million PLX-PAD cells per dose, and the third receiving placebo.

The primary safety endpoint was clearly met, with no serious adverse events reported at either dose level. It showed that PLX-PAD cells were safe and well tolerated. The trial's primary efficacy endpoint was the change in maximal voluntary isometric contraction force of the gluteal muscle at six months post-surgery. Efficacy was shown in both PLX-PAD treated patient groups, with the group receiving the 150 million cell dose displaying a statistically significant 500% improvement over the placebo group in the change of the maximal contraction force of the gluteal muscle. Patients treated at the 300 million cell dose demonstrated a 300% improvement over the placebo, the company noted.