FDA Orders Clinical Hold on Biologic Trial

A Phase II trial of a treatment designed to repair heart muscle in patients with heart failure has been placed on clinical hold at the FDA’s direction after a patient suffered a serious adverse event (SAE) related to “anesthesia management,” Aastrom Biosciences says. The FDA allowed one more patient to undergo the procedure and asked for monitoring of patients who have been given the treatment. A company spokeswoman said the clinical hold will likely be lifted once the FDA finishes evaluating the SAE.
Clinical Trials Advisor