Consistent with FDA requirements, Vericel is posting its policy regarding the compassionate use of product candidates it is currently investigating for the treatment of serious conditions.
Expanded access, or compassionate use, refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. Vericel understands the need and importance for expanded access programs. FDA’s description of the Program may be found here: https://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm
Vericel’s goal is to provide access to our investigational therapies at the appropriate time and in the appropriate format.
Vericel is currently investigating the use of ixmyelocel-T, an autologous expanded multicellular therapy, for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy. Vericel completed enrollment and treatment of patients in a Phase 2b ixCELL-DCM study in February 2015 and, on March 10, 2016, announced the trial had met its primary endpoint of reduction in clinical cardiac events and that the incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable to patients in the placebo group. Patients were then followed for an additional 12 months for safety. Because the trial met the primary endpoint, patients who received placebo or were randomized to ixmyelocel-T in the double-blind portion of the trial but did not receive ixmyelocel-T were offered the option to receive ixmyelocel-T. Vericel successfully treated the last patients in February, 2017, and the last follow-up visit will occur approximately one year later.
A link to the information regarding ixmyelocel-T’s clinical program is available at: https://clinicaltrials.gov/ct2/results?term=ixmyelocel-T&Search=Search
Currently, Vericel is not actively manufacturing ixmyelocel-T, and is not in a position to provide expanded access to the product.
If you have additional questions, please speak with your physician or contact Vericel Medical Affairs at 617-588-5555.