Pluristem Therapeutics intends to conduct a U.S./EU Phase III trial assessing use of PLX-PAD (PLacental eXpanded) cells to support recovery following surgery for femoral neck fracture.
The study design builds upon positive data from the Phase II trial which showed that PLX-PAD cells induced significant muscle regeneration following total hip replacement. Compared to placebo, patients treated with PLX-PAD at the time of surgery showed a 500% improvement in muscle force and a 300% improvement in muscle volume at 6 months.
Earlier results from the Phase I/II study were announced in 1Q15.
Sources: Plurstem Therapeutics, Inc.; ORTHOWORLD Inc.