- Pluristem Therapeutics (NASDAQ:PSTI -16.4%) reports results from a Phase 1/2 trial evaluating the safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after hip replacement (total hip arthroplasty). Twenty patients in the study were randomized into three treatment groups. The first group (n=7) received 150M PLX-PAD cells, the second group received 300M PLX-PAD cells (n=6) and the third received placebo (n=7). Each patient received injections in the gluteal muscle that had been traumatized during surgery.
- Patients receiving 150M PLX-PAD cells demonstrated a statistically significant improvement (p=0.0067) in maximal voluntary isometric contraction force of the gluteal muscle in the operated leg six months after total hip replacement (31.1 Nm versus 5.4 Nm). The company also reports that patients in this group also demonstrated a statistically significant improvement (p=0.0114) in muscle force in the contralateral (non-operated) gluteal muscle (19.4 Nm versus 0.5 Nm) compared to placebo, but no explanation as to why the numbers are different for the placebo group (5.4 Nm vs 0.5 Nm).
- Patients treated with 300M PLX-PAD cells failed to achieve a statistically significant improvement in muscle force (p=0.227).
- The development of PLX-PAD is ongoing.