Aastrom Biosciences has launched a prospective, multicenter clinical trial to evaluate a catheter-based treatment for dilated cardiomyopathy (DCM) through the treatment of its first patient.
The phase 2 U.S. clinical trial will study the safety and efficacy of the company’s tissue repair cells (TRCs) that will be administered via catheter to patients who have been diagnosed with heart failure (HF) due to DCM. TRCs are produced from a small sample of bone marrow taken directly from the patient.
The trial will seek to enroll 24 patients with DCM—12 with non-ischemic DCM and 12 patients with ischemic DCM. Patients will be randomized at a 2:1 ratio to receive either TRC treatment with standard-of-care or standard-of-care only, according to Ann Arbor, Mich.-based Aastrom.
The study will evaluate major adverse cardiac events (MACE) as the primary endpoint and will also assess left ventricular ejection fraction, HF status, change in left ventricular (LV) and right ventricular dimensions and in LV volumes and quality of life as secondary outcomes.
"There are currently very limited effective treatment options for DCM aside from heart transplant," said Timothy D. Henry, MD, director of cardiovascular research at the Minneapolis Heart Institute, who treated the trial's first patient. "This condition is associated with significant mortality and the prognosis for most patients is usually grim. My hope is that Aastrom's TRCs will become an important new addition to our treatment options for DCM."
According to Aastrom, a previous clinical trial, IMPACT-DCM, evaluated the safety of TRC delivery via a surgical method. The results are still pending. The company said that it expects the trial to be completed August 2011 and expects the primary data collection to take place August of this year.