A University of Utah researcher is heading a multicenter clinical trial to determine if injecting a patient's own stem cells will help patients in heart failure.
The yearlong, five-center study will look at safety and whether injecting "cardiac repair cells" improves heart function. It's the first study in the country on treating both ischemic and non-ischemic heart failure, including the 40 percent for which no cause is known. Heart failure can result from a heart assault like heart attack or bypass surgery, for example, or from chemotherapy or following having a baby. Even viruses may cause heart failure.
About three tablespoons of a study subject's own bone marrow is removed, compared to two or three cups. That small amount is then cultured to grow more and the strongest cells that survive after two weeks are reinjected. Using a minimally invasive technique developed by Dr. Amit N. Patel, study lead investigator and director of cardiovascular regenerative medicine at the U., three little incisions are made in the chest and a camera is inserted to guide the process of injecting stem cells into the left ventricle. They're injecting two types of cells, those that make heart muscle stronger and those that promote formation of blood vessels.
There will be no mystery as to who receives what in this randomized study, Patel said. Those in the control arm will receive the best medical therapy for their heart failure. Therapy-arm participants will undergo the procedure to get the stem cell injections and will be hospitalized for two to five days. Should the study show that the patients who get the cells are doing better, without safety concerns, plans call for moving the control group into an after-the-fact therapy group and they, too, will receive their stem cells at the expense of the sponsor, Aastrom Biosciences.
"The potential benefit is that everyone gets the cells," said Patel.
They plan to enroll 40 patients, says Patel. To participate, one must have been diagnosed with heart failure and have an injection fraction of no more than 30 percent (normal is 65). They're considering people ages 18 to 86. People who don't qualify for this one may be able to participate in one of several others Patel is overseeing, he said.
For information, call Patty Meldrum at 801-581-5311 and refer to the "Impact" study.