Aastrom Biosciences will initiate its second clinical trial for the treatment of dilated cardiomyopathy (DCM), after a positive 30-day review of Aastrom’s Investigational New Drug (IND) submission by the FDA. The second trial is a 24 patient US Phase II clinical trial to evaluate the catheter delivery of Cardiac Repair Cells (CRCs) for the treatment of DCM.
The new trial expands the company’s cardiovascular program that includes a US Phase II IMPACT-DCM clinical trial evaluating the direct surgical delivery of CRCs. The FDA previously granted CRCs an Orphan Drug Designation for the treatment of DCM.
The primary objective of open-label, Phase II study, is to assess the safety of CRCs delivered by catheter injection in patients with DCM, efficacy measures including heart failure stage and cardiac function parameters will also be assessed. Patients will be followed for 12 months post treatment.
Elmar Burchardt, vice president of medical affairs at Aastrom, said: “Given the encouraging initial results in our surgical-based, open-label clinical trial, we are expanding our cardiovascular program to include a catheter-based delivery method for these critically ill patients.
“Our catheter-based delivery method is less invasive than the surgical approach and therefore increases the number of potential patient candidates for CRC treatment. End-stage heart failure patients currently have limited therapeutic options other than heart transplantation and mechanical pump assist devices. By expanding the delivery options for CRCs to include the catheter delivery by cardiologists, we are complementing the surgical delivery by cardiac surgeons.”