University of Utah researchers are going to be the first in the country to inject patients' own stem cells into their hearts to treat two types of heart failure.
After drawing about 3 tablespoons of patients' own bone marrow, researchers will grow cardiac-repair cells -- believed to help heart muscles and improve blood flow -- in culture for about 12 days. The cells that survive culture are healthier than the original ones extracted from the patient, said Amit N. Patel, director of cardiovascular regenerative medicine at the U.'s School of Medicine.
Two weeks later, the newly grown stem cells will be injected directly into the left ventricle of the patients' hearts during a minimally invasive surgery developed by Patel, the national principal investigator of the Aastrom Biosciences-sponsored Phase II clinical trial. Most patients will leave the hospital two to three days after surgery -- and within six months, will start to feel the results, he said.
In stem cell clinical trials conducted outside of the country, patients experienced between 20 percent and 100 percent improvement. "This is truly unique in the type of patients and the type of delivery," Patel said.
The one-year Cardiac Repair Cell Treatment of Patients with Dilated Cardiomyopathy study -- the first trial of its kind in the country -- will provide "patients who have limited to no other options with a viable treatment," said Patel. "By using a patient's own cells, we eliminate the concern of rejection and the need for potentially harmful immunosuppressive drugs."
The treatment is targeted at patients with two types of heart disease. Ischemic heart disease occurs when hearts don't get enough blood and oxygen because of heart muscle damage caused by coronary artery disease. Non-ischemic heart disease describes muscle damage caused by other means, including viruses or drug use, Patel said.
A subset of these patients has dilated cardiomyopathy, a condition that leaves the heart weakened, enlarged and unable to pump blood efficiently.
"For most of these patients, the only option has been a heart transplant," said David A. Bull, professor and division chief of cardiothoracic surgery in the U.'s medical school and the U. site's principal investigator.
So far, Patel said, about 50 out-of-state patients -- many of whom are following him from Pittsburgh, Pa., where he moved from three months ago -- are "lined up" to participate.
He'd like the first patient treated at the U., however, to be from the Beehive state.
Patients diagnosed with congestive heart failure who are between the ages of 18 and 86 may be eligible to participate in the Phase II trial.
Nationwide, 40 patients -- 20 with ischemic dilated cardiomyopathy and 20 patients with non-ischemic dilated cardiomyopathy -- will be enrolled at the University of Utah and four other sites.
For additional information, call research coordinator Patty Meldrum at 801-581-5311.