Pluristem Therapeutics has commenced a Phase I/II clinical trial designed to assess the safety and efficacy profile of placental expanded (PLX) cells in treating muscle injury.
The German competent authority in the European Union, The Paul Ehrlich Institute (PEI), approved the trial, which will be conducted at the Klinik fur Orthopadie on the campus of the Charite Universitatsmedizin in Berlin, Germany.
Pluristem chairman and CEO Zami Aberman said the company sees the clinical trial as an entry into the orthopedic and sports medicine markets.
"The response of the gluteal muscle to our PLX cells will be an indication for us of how well our cells would help various muscle injuries," Aberman said.
The randomised, double blinded trial will assess two doses of PLX cells compared to placebo administered through intramuscular injections directly into the site of the lacerated gluteal muscle, before suturing.
The study cohort consists of around 18 patients equally divided between high and low-dose PLX cell groups, and placebo group.
The muscle injury studied in the Phase I/II trial will be trauma sustained to the gluteal buttock muscle that occurs during hip replacement.
Hip replacement surgery generally involves splitting the gluteal muscle to obtain access to the hip joint.
According to the data from muscle injury animal studies, usage of PLX cells over placebo demonstrated a significant improvement in rehabilitation function and time.
Improvement in the functional recovery of the gluteal muscle as measured by maximal contraction force is the endpoint of the study.