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CardioCell launches trial to assess stem cell therapy for chronic HF

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CardioCell announced the initiation of a phase 2a trial of ischemia-tolerant mesenchymal stem cell therapy for patients with chronic HF due to nonischemic cardiomyopathy.

The single blind, multicenter, crossover trial will include more than 20 patients with chronic HF due to nonischemic cardiomyopathy recruited from three US hospitals, according to a press release.

The patients will be randomly assigned to receive a single IV dose of placebo or ischemia-tolerant allogeneic mesenchymal bone marrow stem cells. The cells, which are grown under hypoxic conditions, secrete greater amounts of growth factor and other proteins linked with neoangiogenesis and healing. At 90 days, the control and treatment groups will switch, and the control group will receive the IV stem cell therapy. Assessment will occur at baseline, 90 days and 180 days and will be measured by MRI to observe changes in ejection fraction and segmental changes in contractility, according to the release.

This trial is the first launch in the CardioCell HF program designed by Mihai Gheorghiade, MD, CardioCell scientific advisory board member and professor of medicine-cardiology and surgery-organ transplantation at Northwestern University Feinberg School of Medicine, according to the release.

“Approximately 35% of chronic HF patients suffer from abnormal heart function not related to coronary artery disease,” principal investigator Javed Butler, MD, director of heart failure research and professor of medicine at Emory University stated in the release. “Some patients respond to standard drug- and device-based therapies, but many others do not. Those patients are at risk for worsening HF, and there are currently no options except a transplant or left-ventricular assist device implantation for them. We designed this protocol based on CardioCell’s [ischemia-tolerant mesenchymal stem cell] therapy to test if [ischemia-tolerant mesenchymal stem cell] treatment via intravenous injection can show efficacy in these patients with nonischemic cardiomyopathy.”