Date: 2012-08-07
Type of information:
phase: 1-2
Announcement: authorization
Company: Pluristem Therapeutics (Israel)
Product: PLX cells (PLacental eXpanded cells)
Action mechanism:
Disease: regeneration of injured gluteal musculature following total hip replacement
Therapeutic area: Regenerative medicine - Muscular diseases
Country: Germany
Trial details: 18 patients scheduled to undergo a total hip replacement will participate in this study. The subjects will randomize to one of three treatment arms, including two active-treatment arms and one placebo arm. On day one of the study, subjects will undergo total hip replacement surgery. Subjects will receive either PLX cells or placebo, through intramuscular injection, during the procedure. The expected total active duration of the study for each subject is 12 months.
Latest
news: Pluristem Therapeutics, a developer of placenta-based cell therapies, has announced it has received approval from the Paul-Ehrlich-Institute (PEI), the medical regulatory body in Germany, to commence a Phase I/II randomized, double blind, placebo controlled study to assess the safety and efficacy of its PLX cells, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement.
