As a follow-up to the positive results of its Phase II trial of its PLX-PAD cells in total hip surgery, Pluristem Therapeutics, Inc. will now be conducting a Phase III trial to assess PLX-PAD cells in recovery following surgery for femoral neck fracture.
Pluristem: Trial of PLX-PAD Cells for Femoral Neck Fracture
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As indicated in the July 27, 2016 news release, “The Phase III study design builds upon positive data from a Phase II trial which showed that PLX-PAD cells induced significant muscle regeneration in patients who had undergone total hip replacement surgery. Patients treated with PLX-PAD at the time of surgery showed a 500% improvement in muscle force and a 300% improvement in muscle volume six months after surgery, as compared to the placebo group.”
Asked about specific challenges in designing the trial protocol, Pluristem Chairman and CEO Zami Aberman told OTW, “We are assessing the ability of PLX-PAD to significantly improve patient mobility after surgery for femoral neck fracture, since loss of mobility is a significant contributor to patient morbidity and mortality after the surgery. As a result, an important focus in the design of the trial was choosing the endpoints that would best measure mobility. With expert opinions from leading authorities on orthopedic surgery and on rehabilitation, we believe we have chosen the most appropriate endpoints for the proposed Phase III trial in the U.S. and the pivotal trial in Europe, for which we have already submitted a protocol.
“Orthopedic surgeons have wonderful mechanical implants to use in these femoral neck fracture surgeries, as well as refined surgical techniques, but cell therapies such as Pluristem’s PLX-PAD could potentially provide an important biological tool to improve outcomes and decrease mortality. Mortality has not decreased significantly in the past decade, and there is an unmet need here. It would be so important to give patients the best outcome possible, in synergy with all of the efforts and progress in orthopedic surgery and medical devices.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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