The US Food and Drug Administration (FDA) has temporarily suspended Aastrom Biosciences’ enrollment and patient treatment clinical trial following reports of serious adverse effects, including a patient’s death.
The company said that a patient died after being released from the hospital following treatment in the trial, even though the cause of death has not yet been determined.
Aastrom vice president of medical affairs Elmar R Burchardtsaid said that the company remained committed to ensuring patient safety and will work to resume patient enrollment and treatment in the IMPACT-DCM trial as soon as possible.
The US FDA has placed the trial on temporary clinical hold, pending an investigation.
The trial was conducted to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy. Patients in the trial were treated with the company’s cardiac repair cells, an autologous, mixed-cell product that contains expanded populations of stem and early progenitor cells produced from a patient’s own bone marrow.
On completion of the investigation, Aastrom would work closely with the FDA to provide any information required so as to accelerate its review and to resolve this matter, the company said.