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Investigational treatment improved outcomes in patients with progressive HF
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Transendocardial injection of ixmyelocel-T was well tolerated by patients with progressive HF caused by dilated cardiomyopathy, according to results of a phase 2a study presented during a late-breaking session at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
The trial included 22 patients with progressive HF due to dilated cardiomyopathy from both ischemic and nonischemic origins. All patients had NYHA Class III/IV and left ventricular ejection fraction of ≤30%. Patients were randomly assigned to ixmyelocel-T injection (Aastrom Biosciences) or to a control group. Researchers followed each patient at 3, 6 and 12 months after injection.
Timothy D. Henry
At 12 months, results showed no procedural complications and no difference in adverse events between the two groups. Patients with ischemic dilated cardiomyopathy treated with ixmyelocel-T had a lower mean number of major adverse clinical events (0.22 vs. 1.67). These patients were more likely to have improved NYHA Class, 6-minute walking distance scores and ejection fraction compared with patients with nonischemic dilated cardiomyopathy who received the treatment and those in the control group.
Ixmyelocel-T is developed by culturing a patient’s bone marrow for 12 days to increase the numbers of immune cells. The resulting cell treatment is then injected into the patient’s heart muscles to encourage growth of new tissue and improve inflammation, according to a press release.
“An increasing number of patients have progressive HF due to dilated cardiomyopathy, even after treatment with drug therapy and surgical intervention,” Timothy D. Henry, MD, FSCAI, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, said in a press release. “[These] results provide a strong basis for a larger trial of this treatment in patients with dilated cardiomyopathy.”
A phase 2 trial yielded positive results, and a large phase 3 trial is currently under way, the researchers said. Aastrom Biosciences this week announced that the first patient was enrolled in the phase 3 REVIVE clinical study. The randomized, double blind, placebo-controlled, multicenter trial is expected to enroll 594 patients with critical limb ischemia who have no option for revascularization and also have existing tissue loss due to ischemia to assess the efficacy and safety of ixmyelocel-T. Patients will be followed for 18 months. The primary endpoint will be amputation-free survival at 12 months.
For more information:
- Henry TD. Late-breaking clinical trial. Presented at: the Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 9-12, 2012; Las Vegas.
Disclosure: The study was sponsored by Aastrom Biosciences. Dr. Henry has received support from Angioblast.