INTRACORONARY injection of a patient’s own bone marrow (BM) cells could emerge as the ultimate treatment for heart attacks. Selected for their healing potential, a particular group of BM cells – known as endothelial progenitor cells – are believed to trigger healing and blood flow recovery.
In the PreSERVE-AMI Phase II trial, sponsored by NeoStem, Inc. and involving physicians from 60 locations treating 161 subjects, a marker called CD34 was used to distinguish these rare cells from other BM cells prior to intracoronary injection.
“This was an enormous undertaking, one that broke new ground in terms of assessing cell therapy rigorously,” said Dr Arshed Quyyumi, Professor of Medicine, Emory University School of Medicine, and Co-director, Emory Clinical Cardiovascular Research Institute, Atlanta, Georgia, USA. “We made some real progress in determining the cell type and doses that can benefit patients, in a group for whom the risks of progression to heart failure are high.”
Patients were required to demonstrate an ejection fraction of <48% in a 4-day period following heart attack and stent placement. The average starting ejection fraction (34%) indicated severe heart injury; subjects had cells extracted from their BM following a selection process, and received an intracoronary injection of sorted BM cells or a placebo. However, the number of administered cells varied across subjects, and while the minimum level was set at 10 million cells, some subjects were given up to 40 million.
Major adverse cardiac events were overall reduced in the treatment group versus the control group, while on average ejection fraction experienced greater elevation in the treatment group. Mortality measured 3.6% and 0% in the control and treatment groups, respectively.
Neostem hope to administer 20 million CD34+ cells to all patients in the future. “If we assume CD34 positive cells are where the action is, it is clear that you need big numbers,” Dr Quyyumi said. “This is a lesson for the cell therapy field moving forward.”