Two randomized, blinded clinical trials at Duke will evaluate the safety and effectiveness of allogeneic stem cells in patients who have experienced myocardial infarction (MI) or heart failure (HF). The study researchers are hoping that the allogeneic stem cells will improve heart function in these patients and reduce clinical events, including the need for hospitalization and therapies for advanced HF. The division of cardiology at Duke University is currently recruiting patients for both trials.
The DREAM-HF trial (A Double-blind, Randomized, Sham-procedure-controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells [CEP-41750] in Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology) involves using a NOGA-guided electromechanical mapping system to guide intramyocardial delivery of stem cells derived from healthy donor bone marrow using a specialized cell-delivery catheter.
“This trial targets patients who have exhausted conventional treatment options, but who remain symptomatic with class II to IV congestive heart failure,” says Thomas J. Povsic, MD, PhD, associate professor of medicine in the cardiology division. Povsic is also the principal investigator of the 2 trials at Duke.
The DREAM-HF trial will enroll more than 1,700 patients who have either been treated in the hospital for HF, needed occasional intravenous diuretic therapy, or have had high levels of brain natriuretic peptide. Participants must have ejection fractions of less than 40% due to either ischemic or non-ischemic causes.
If the treatment used in the DREAM-HF trial is successful, it could lead to the approval of the first stem cell therapy for heart disease. “Today’s medications are aimed at preventing further deterioration of the heart,” Povsic says. “We think stem cells have the capacity to regenerate or allow the heart to recover and improve function. This would be the first trial to show this.”
The aim of the second study, ALLSTAR (Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration), is to determine whether the intracoronary delivery of allogeneic cardiosphere-derived cells can decrease infarct size in patients with recent anterior MI and left ventricular dysfunction.
Stem cells derived from cardiac tissue will be injected into the arteries of study participants who have had anterior MI within the last year and who have an ejection fraction of 45% or less. Approximately 260 patients will be enrolled in the trial.
“The study aims to offer patients who have had a recent heart attack an opportunity to recover function,” details Povsic. “We hope early intervention can help minimize loss of functioning heart muscle, thus preventing HF from developing.”
Both trials are based on earlier, smaller studies. A study of stem cells used in the DREAM-HF trial showed that participants given high dosages had improved heart function. Results from another trial that looked at stem cells similar to those used in the ALLSTAR study showed that the amount of myocardial scarring following MI dramatically decreased with treatment. “These earlier studies showed that stem cells are quite efficacious,” Povsic adds.
To date, Duke has participated in 7 studies using regenerative medicine to treat cardiovascular disease. “We are excited about these 2 new studies because they are the biggest ones to date,” remarks Povsic, who reports that many trials require the use of the special NOGA system—which only 40 US medical centers have. “These are pretty ambitious studies with a lot of potentially positive consequences downstream.”