Stem Cells With Heart Bypass Surgery Trial To Begin At University Of Pittsburgh

The trial will involve patients with ischemic heartdisease who are scheduled for off-pump (beating heart) coronary arterybypass grafting surgery. In addition to assessing the safety andfeasibility of using a patient's own stem cells as a potential therapyfor heart disease, researchers also will be trying to determine justhow many stem cells are needed to produce the best results.

Patientswho give their consent to participate will be randomized to one of fourtreatment groups and neither they nor the researchers will know intowhich 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, UPMCwas given clearance by the FDA to conduct a similar trial in patientsneeding heart assist devices as a bridge to organ transplantation. Bothstudies are being directed by Amit Patel, M.D., M.S., director of theCenter for Cardiac Cell Therapy at UPMC and the University ofPittsburgh McGowan Institute for Regenerative Medicine.

"Stemcell therapy as an adjuvant to traditional bypass surgery is the nextstep to help determine the best way to help very sick heart failurepatients. This is the first randomized study in the U.S. to evaluatethe combination of cell therapy with traditional surgicalrevascularization and may help answer a number of key questions,"explained Dr. Patel, an assistant professor of surgery in the divisionof cardiothoracic surgery, University of Pittsburgh School of Medicine.

"Standardsurgical and catheter-based treatments are reasonably effective fortreating chest pain, reducing the risk of heart attack and improvingheart function. But none has the ability to actually restore or repairdamaged heart tissue. The aim of stem cell therapy is to repopulate theailing heart muscle with cells that may help restore blood supply andhelp the heart regain its ability to contract more effectively andefficiently," added Joon S. Lee, M.D., clinical director of UPMC'sCardiovascular Institute and assistant professor of medicine andassociate chief, division of cardiology, University of PittsburghSchool of Medicine.

Various studies that have been conductedaround the world, including a limited number performed in the UnitedStates, have suggested that when patients with heart failure receivestem cells taken from their bone marrow, their hearts show signs ofimproved function and recovery. However, most of these clinical studiesdid not control for variables that may have influenced patients'clinical improvements, and all but a very few were designed as arandomized and double-blinded trial, the most rigorous method forevaluating clinical interventions.

UPMC researchers expect to askabout 75 patients to participate in the new trial in order to enrolland randomize six patients into each of the four study groups. A personnot involved in the study will select a card from 24 numbered onethrough four to determine which group a patient is to be assigned.Then, with the patient under anesthesia, Dr. Patel's team will harvestbone marrow from the patient's hipbone. While the bypass operation istaking place, the patient's stem cells will be isolated from the bonemarrow and prepared accordingly, depending on the patient's randomassignment. Patients may be randomly selected to one of three groupsthat will receive varying concentrations of stem cells or to a fourthgroup receiving their own blood serum void of stem cells.

Accordingto the American Heart Association, nearly 13 million Americans havecoronary artery disease. Despite medical advances, coronary heartdisease results in about 500,000 deaths each year.