FDA Removes Clinical Hold From Aastrom’ Impact-Dcm Clinical Trial

FDA has removed the clinical hold from Aastrom’ US phase-II Impact-Dcm clinical trial. Patient enrollment would resume at all five initiated clinical sites.

The Impact-Dcm trial is evaluating the use of Cardiac Repair Cells (CRCs), a mixture of stem and progenitor cells derived from a patient’ own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure.

Impact-Dcm is the first clinical trial in the US to evaluate the surgical delivery of autologous cells directly into the human heart muscle. It is intended for the treatment of congestive heart failure associated with DCM, in both ischemic and non-ischemic patients.

FDA informed Aastrom on 17 June that it had completed its investigation into the death of a patient (following treatment with the company’s CRCs), and that the clinical hold has been lifted. Therefore, the Impact-Dcm clinical trial could resume.

Based on autopsy results and medical records, FDA, and Data Safety Monitoring Board (DSMB) have attributed the patient death to progression of the disease, and determined that it was unrelated to the CRC treatment.

George Dunbar, President and CEO, Aastrom, said: Patient safety is top priority for Aastrom. We are saddened by the loss of one of our patients. At the same time, we are grateful that this investigation was conducted in an efficient manner and that the FDA was able to provide prompt review and remove the clinical hold so quickly. This comprehensive review, along with the FDA’s permission to carry on the trial without modifications, underscores the safety of the trial design and that our CRC product played no role in the patient’s death.