Using a multi-cell therapy called Ixmyelocel, produced from a patient's (autologous) own bone marrow mononuclear cells (BM-MNCs), an ongoing clinical trial named "ixCELL-DCM" is being conducted in various locations in the U.S. for patients with heart failure. Because BM-MNC therapy requires a large number of cells, the cells are biologically enhanced to provide immune therapy to the myocardium for patients with heart failure.
"Heart failure continues to be a major cause of morbidity and mortality in the U.S.," said study co-author Dr. Timothy D. Henry of the Cedars-Sinai Heart Institute in Los Angeles. "Despite medical advances, mortality continues to approach 50 percent within five years."
The ixCELL-DCM trial is the first double-blind, placebo-controlled study of ixmyelocel-T administered by catheter injections to patients with heart failure (HF), according to the researchers. Ixmyelocel-T differs from other heart cell therapies because it contains "a complete range of BM-MNC types, but with selective expansion" of certain cell types to provide immune therapy. The year-long study to assess efficacy, safety and tolerability is being conducted for a small number of qualified HF patients with ischemic dilated cardiomyopathy (IDCM) after earlier trials suggested that ixmyeolocel-T might improve clinical, functional, symptomatic, and quality of life outcomes in patients with IDCM.
More information: Henry TD, Schaer GL, DeMaria A, Recker D, Remmers AE, Goodrich J, Patel AN. The iXCELL-DCM Trial: Rationale and Design. Cell Transplant. Appeared or available on-line: March 22, 2016.
