Temple University Hospital Offering New Trial Using Donor Stem Cells to Treat Heart Failure
Temple University Hospital is participating in a nationwide, Phase-3 clinical trial investigating stem cells as a treatment for patients with chronic heart failure due to left ventricular systolic dysfunction (LVSD). LVSD is characterized by a left ventricle that no longer has the ability to contract normally, which results in the heart not being able to pump with enough force to push a sufficient amount of blood into circulation.
The trial, dubbed DREAM-HF, is a double-blind, randomized, placebo controlled trial investigating whether donor stem cells which are injected into the damaged portion of the heart can restore heart muscle function.
“The goal of this trial and several other stem cell trials we have participated in at Temple is to find novel ways to repair injured hearts,” says Rene J. Alvarez, Jr., MD, Vice Chief of Cardiology, Medical Director of the Heart Failure/Cardiac Transplantation Program and heart failure principal investigator of the trial at Temple University Hospital (TUH). “Harnessing the ability to repair a damaged heart is incredibly exciting and it is the direction that heart failure research is going, both clinically and in the laboratory.”
Patients who meet the clinical criteria for participation in DREAM-HF will be randomized into two groups. One group will receive a type of cells called “allogeneic mesenchymal precursor cells” from a human donor. Mesenchymal stem cells are utilized because they have the ability to differentiate into a variety of cell types. Doctors will use a mapping tool called NOGA® to identify the exact areas of the heart which are damaged, then inject the stem cells directly into the damaged area to see if they become cardiomyocytes and restore the contractility of the left ventricle. The second group of trial participants will still undergo the procedure, but will instead receive a placebo.
“The key difference between this trial and recent heart failure stem cell trials is that this one does not rely on the stem cells of a sick patient,” says Jon C. George, MD, Adjunct Research Instructor at the Cardiovascular Research Center at the Lewis Katz School of Medicine at Temple University, and procedural interventional principal investigator of the trial at TUH. “Previous research has shown that the quantity and quality of stem cells may be poor in sick patients and the hope is that the donor cells utilized in DREAM-HF will prove to have a better capacity to regenerate healthy heart tissue.”
All patients in the trial will undergo two years of monitoring and follow-up visits, which will include – among other things – echocardiograms, heart failure questionnaires and exercise tests. The primary outcome measure is time to first heart failure-related major adverse cardiac event following stem cell or placebo injection.
Temple is currently enrolling patients in the trial. DREAM-HF is sponsored by Teva Pharmaceutical Industries.
Editor’s Note: Neither Dr. Alvarez, Dr. George nor any member of their immediate families has financial interest in Teva Phamaceutical Industries.