Pluristem Therapeutics' placenta-derived muscle injury therapy has hit safety and efficacy goals in a Phase I/II trial, offering hope for a new treatment approach.
The Tel-Aviv, Israel-based group said top-line results show PLacental eXpanded (PLX-PAD) cells are safe to use, with no adverse events reported, and that the primary efficacy endpoint -voluntary contraction of previously injured gluteal muscle at six months after hip replacement - was also met.
Patients treated with PLX-PAD - an injectable form of stem cells derived from human placentas and expanded in bioreactor systems - showed greater improvement in maximum voluntary muscle contraction force than the placebo arm, with those receiving the 150 million cell dose displaying a 500% improvement and those given the 300 million cell dose a 300% improvement.
Muscle volume was also found to be increased in the PLX-PAD group, as shown by an MRI scan, with the 150 million cell group showing a 300% improvement over the placebo and those receiving the 300 million cell dose a 150% improvement, suggesting a potential mechanism for the seen improvement in muscle force, the researchers note.
According to Pluristem, the results indicate that PLX cells may be effective in treating orthopaedic injuries including muscles and tendons, and based on the results it said it plans to "move forward with implementing our strategy towards using PLX cells in orthopaedic indications and muscle trauma".
PLX-PAD is in clinical trials for multiple therapeutic indications.