Aastrom Biosciences, Inc, a leading regenerative medicine company, reported that the US Food and Drug Administration (FDA) has removed the clinical hold from the company's US phase-II IMPACT-DCM clinical trial and that patient enrolment would resume at the four 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's own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure.
On March 3, 2009, 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. To date, nine of 40 patients have been enrolled in the IMPACT-DCM trial at the first three sites: The Methodist DeBakey Heart & Vascular Center, Houston, TX, Baylor University Medical Center, Dallas, TX, and The University of Utah School of Medicine, Salt Lake City, UT. In addition, the fourth site, the Cleveland Clinic Heart and Vascular Institute in Cleveland, OH, was recently initiated and trained for participation in the IMPACT-DCM trial. Activation of the fifth clinical site is underway.
"We are very grateful to the FDA for completing this review quickly and efficiently," stated George W Dunbar, president and chief executive officer at Aastrom. "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 enrolment in this trial by the end of calendar year 2009."
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. The randomized, controlled, prospective, open-label, phase-II study seeks to enrol 20 patients with ischemic DCM and 20 patients with non-ischemic DCM at five clinical sites in the US Participants must have a left ventricular ejection fraction of less than or equal to 30 per cent (60 to 75 per cent is typical for a healthy person) and meet certain other eligibility criteria. All patients in each group will receive standard medical care and 75 per cent of the patients will be treated with CRCs through direct injection into the heart muscle during minimally invasive open heart surgery. 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.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue.