February 2014

Study of cell therapy for muscle injury meets primary safety, efficacy endpoints

Pluristem Therapeutics, a developer of placenta-based cell therapies based in Haifa, Israel, released on January 21 positive results from its phase I/II safety and efficacy trial of its PLX-PAD (placental expanded) cells for treatment of muscle injury.

PLX-PAD cells, which release therapeutic proteins in response to local and systemic inflammatory and ischemic conditions, are grown using 3D microenvironmental technology and require no tissue matching prior to use.

Investigators for the trial, conducted at the Charité–Universitätsmedizin Berlin in Germany, randomized participants into three groups. All had undergone total hip replacement with the standard transgluteal approach that necessitates injury of the gluteus medius muscle. After surgery, two groups received different doses of the injectable PLX-PAD cells into the gluteal muscle (n = 13) while the third received placebo injections (n = 7).

Patients tolerated the PLX-PAD injections well, and the intervention met the study’s primary endpoint for efficacy, with patients treated with PLX-PAD cells showing a statistically greater improvement in maximal voluntary muscle contraction force six months after hip replacement compared with the placebo group.

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