February 2015

Trial finds Pluristem product safe, improves post-THA muscle strength

A phase I/II trial of Pluristem Therapeutics’ expanded placental cell product for treatment of muscle injury after total hip arthroplasty (THA) found significant improvements in maximal voluntary muscle contraction force six months postsurgery in both operated and nonoperated gluteal muscle.

The Haifa, Israel-based com­pany reported the surprising improvements in nonoperated gluteal muscle on February 2, following its January announcement that the PLX-PAD (placental expanded) product had successfully met its primary safety and efficacy endpoints (the primary efficacy finding was significant improvement in maximal voluntary isometric contraction force of the gluteal muscle in the operated leg).

The 20 patients in the randomized, double-blinded, placebo-controlled study conducted at the Orthopedic Clinic of the University Hospital Charité in Berlin, Germany, received injections of 150 million or 300 million PLX-PAD cells or a placebo shot into gluteal muscle traumatized during THA.

Patients treated with 150 million cells showed 500% improvement over placebo in maximal contraction force of the operated gluteal muscle, while those treated with 300 million cells had improvements of about 300% compared with placebo. In nonoperated legs, the magnitude of improvement in muscle force was approximately 40 times larger in patients treated with 150 million cells compared with placebo.

Investigators will present the complete dataset, including biopsy results and functional assessments, once final analyses are completed, the company said.

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