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Pluristem Advances Towards Multinational Phase III Trial of PLX-PAD to Improve Recovery Following Surgery for Hip Fracture

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Additional Relevant Details Pluristem intends to conduct a Phase III trial assessing its PLX-PAD cells in recovery following surgery for femoral neck fracture, which is the most common form of hip fracture. The trial protocol is now being designed by Pluristem and its Clinical Advisory Board (CAB), which is comprised of worldleading orthopedic surgeons, and experts in rehabilitation. Pluristem is planning to meet with the FDA later this year to discuss the Phase III protocol. The Company has already submitted this protocol to the European Medicines Agency (EMA) following consultation with the Adaptive Pathways Project Group. Pluristem’s program in critical limb ischemia is already being developed via the Adaptive Pathways Project. The Phase III study design builds upon positive data from a Phase II trial which showed that PLXPAD 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.
http://www.pluristem...
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Occurred on:
Jul 27, 2016
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Related Keywords Plx-pad, Hip Fracture, Femoral Nec Fracture