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Phase 2 trial launches for combination stem-cell treatment for ischemic HF
A trial studying a combination of two types of stem cells to repair damage from ischemic HF has begun enrolling patients, according to the Minneapolis Heart Institute Foundation.
The phase 2, randomized, blinded, placebo-controlled CONCERT trial will study a combination of autologous bone marrow derived mesenchymal cells and endomyocardial biopsy derived c-kit+ cardiac stem cells. The trial will enroll 160 patients across seven sites, the institution stated in a press release.
Researchers are enrolling patients with ischemic cardiomyopathy with ejection fraction 35% and a significant amount of scar tissue (> 5%) as assessed by MRI.
The study will assess the safety and efficacy of delivering the stem cells in combination or individually vs. placebo. Outcomes of interest include left ventricular function, clinical outcomes and quality of life.
“This combination of cells represents the most potent cell therapy product ever delivered to patients,” Jay Traverse, MD, director of research at the Minneapolis Heart Institute Foundation, said in the release. “Confirming that both types of stem cells together work better than either individual cell type could lead to improved patient outcomes and better quality of life for [patients with ischemic HF].”
The trial is sponsored by the NIH and the Cardiovascular Cell Therapy Research Network, of which the Minneapolis Heart Institute Foundation is a charter member.
Disclosure: Traverse reports no relevant financial disclosures.