According to the results of an internal review conducted at the clinical site, and a second review by the trial’s independent data safety monitoring board, this event has been attributed to anesthesia administration and management in this single patient.
Furthermore, these two reviews separately determined that this event was not related to the surgical approach or the use of Aastrom’s cardiac repair cells (CRCs) in this procedure. This patient has received appropriate treatment, has fully recovered from this isolated event and continues to be monitored in accordance with the study protocol, the company said.
In compliance with regulatory requirements and standard operating procedures, this event was reported directly to the FDA and Aastrom has complied with a subsequent verbal communication from the FDA that the IMPACT-DCM trial be placed on clinical hold at all trial sites pending completion of a more comprehensive review of this event.
IMPACT-DCM is the first clinical trial in the US 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 in both ischemic and non-ischemic patients, said Aastrom.
Elmar Burchardt, vice president of medical affairs at Aastrom, said: We believe, and all available information indicates, that this is an isolated incident unrelated to the safety of our CRC cell product. We are proactively and rapidly supporting the FDA review of this event and look forward to continuing treatment of this critically ill patient population in the IMPACT-DCM trial.