Pluristem Therapeutics has gained Paul-Ehrlich-Institute (PEI) approval to begin Phase I/II study for muscle regeneration in Germany.
The randomized, double blind, placebo controlled study will assess the safety and efficacy of its PLX cells, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement.
Pluristem chairman and CEO Zami Aberman said, "This is an important new indication for PLX cells, as beyond potentially showing safety and efficacy in muscle regeneration after hip replacement surgery, this opens PLX cells to the possibility of addressing large new markets in sports injury treatment and muscular regenerative medicine."
The study with expected total active duration of 12 months for each subject will randomize 18 patients to one of three treatment arms, including two active-treatment arms and one placebo arm.
On the first day of the study, subjects will undergo total hip replacement surgery and will receive either PLX cells or placebo, through intramuscular injection, during the procedure.
