Aastrom halts mid-stage trial after patient death
Aastrom Biosciences shares slid 24 percent Friday morning on the news that the company halted a mid-stage trial for a congestive heart failure treatment following the death of a patient. The Ann Arbor, MI-based company develops stem cell treatments for severe cardiovascular diseases. The trial, IMPACT-DCM, was designed to evaluate Aastrom's cardiac repair cells (CRCs) for the treatment of congestive heart failure associated with dilated cardiomyopathy (DCM). The treatment involved surgical delivery of CRCs directly into the heart muscle.
The patient died at home after being released from the treatment facility. Aastrom says the cause of death has yet to be determined, but an investigation is underway. The company has temporarily suspended enrollment and patient treatment and will continue to monitor other trial participants. Aastrom also says it plans to have an independent data safety monitoring board assess the circumstances of the death.
The company does expect to resume the study. "Patient safety has been and continues to be our primary concern," stated Elmar R. Burchardt, M.D., Ph.D., Vice President, Medical Affairs at Aastrom. "We will continue to work closely with the trial site, the DSMB and the FDA to review the events surrounding the death of one of the patients in this clinical trial. We remain committed to ensuring patient safety and will work to resume patient enrollment and treatment in the IMPACT-DCM trial as soon as possible."