The University of Pittsburgh Medical Center (UPMC) has been granted approval by the U.S. Food and Drug Administration (FDA) to conduct a clinical trial to determine the safety and feasibility of injecting a patient's own bone marrow-derived stem cells directly into the heart during conventional heart bypass surgery.
The trial will involve patients with ischemic heart disease who are scheduled for off-pump (beating heart) coronary artery bypass grafting surgery. In addition to assessing the safety and feasibility of using a patient's own stem cells as a potential therapy for heart disease, researchers also will be trying to determine just how many stem cells are needed to produce the best results.
Patients who give their consent to participate will be randomized to one of four treatment groups and neither they nor the researchers will know into which group they are assigned until the conclusion of the study. Researchers hope to enroll a total of 24 patients - six in each group - who they will follow over the course of one year.
In May, UPMC was given clearance by the FDA to conduct a similar trial in patients needing heart assist devices as a bridge to organ transplantation. Both studies are being directed by Amit Patel, M.D., M.S., director of the Center for Cardiac Cell Therapy at UPMC and the University of Pittsburgh McGowan Institute for Regenerative Medicine.
"Stem cell therapy as an adjuvant to traditional bypass surgery is the next step to help determine the best way to help very sick heart failure patients. This is the first randomized study in the U.S. to evaluate the combination of cell therapy with traditional surgical revascularization and may help answer a number of key questions," explained Dr. Patel, an assistant professor of surgery in the division of cardiothoracic surgery, University of Pittsburgh School of Medicine.
"Standard surgical and catheter-based treatments are reasonably effective for treating chest pain, reducing the risk of heart attack and improving heart function. But none has the ability to actually restore or repair damaged heart tissue. The aim of stem cell therapy is to repopulate the ailing heart muscle with cells that may help restore blood supply and help the heart regain its ability to contract more effectively and efficiently," added Joon S. Lee, M.D., clinical director of UPMC's Cardiovascular Institute and assistant professor of medicine and associate chief, division of cardiology, University of Pittsburgh School of Medicine.