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.
If you have additional questions, please speak with your physician or contact Vericel Medical Affairs at 617-588-5555.