The Impact-DCM trial is evaluating the use of cardiac repair cells (CRCs), a mixture of stem and progenitor cells derived from a patient’s own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure.
The FDA informed Aastrom that it had completed its review of the company’s response to the issue cited in the FDA clinical hold letter and that the clinical hold had been lifted; therefore, the Impact-DCM clinical trial could resume.
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 DCM in both ischemic and non-ischemic patients, said Aastrom. The randomized, controlled, prospective, open-label, Phase II study seeks to enroll 20 patients with ischemic DCM and 20 patients with non-ischemic DCM at five clinical sites in the US.
While the primary objective of this study is to assess the safety of CRCs in patients with DCM, efficacy measures including left ventricular ejection fraction and other cardiac function parameters as well as heart failure stage will be monitored. Patients will be followed for 12 months post treatment.
George Dunbar, president and CEO of Aastrom, said: “With the hold removed, we will be able to resume the Impact-DCM trial and continue to treat these critically ill patients who have no other treatment options available. Even with this short delay, we still anticipate completing patient enrollment in this trial by the end of calendar year 2009.”