Cell Therapy begins European marketing authorization process for stem cell therapy Heartcel

Wales-based biotech company Cell Therapy will begin the application process for a conditional European marketing authorization for Heartcel.

Heartcel is the first allogeneic stem cell therapy to regenerate the human heart, and Cell Therapy’s application follows a pre-submission meeting with the European Medicines Agency. The filing is planned for mid-2016 and if successful the approval could take place in 2017.

Heartcel demonstrated a two year MACE-free survival for all patients in a Phase II clinical trial studying myocardial regeneration. All of the patients in the trial, all of which suffered from advanced heart failure, are still alive after an average of 28.4 months versus an expected mortality rate of 70%. None have suffered cardiac events such as heart attack or stroke.