MINNEAPOLIS - A first-of-its-kind study is just getting underway at University of Minnesota Physicians Heart at Fairview, in Minneapolis. The FDA-approved trial is designed to test the impact of stem cells on restoring the heart's muscle function in patients suffering from advanced heart failure. The results of the trial could impact the future of health care in the area of heart disease, and may one day save lives.
Lee Magnuson, 58, of Spring Brook, WI, became one of the first patients to enroll in the study.
"To me it was a no brainer, I had to contribute," said Magnuson.
Magnuson suffered a heart attack on October 5, 2010. He spent about a year being treated with medication and undergoing cardiac rehabilitation in an attempt to strengthen his heart muscle.
But, by August of 2011, he said, his doctor could tell things were not going well. That is when his doctor recommended implanting a left ventricular assist device (LVAD). The device helps pump blood from the lower left chamber of the heart to the rest of the body. His doctor also told him about the U of M study.
"This trial is designed for heart failure patients in the end stage of heart failure, with no options for treatment," explained Ganesh Raveendran, M.D., who is the principal investigator of the clinical trial. "The question this trial is designed to answer is whether or not patients on a left ventricular assist device with the stem cell component do better than patients with only the device, which right now is the standard care for patients experiencing advanced heart failure."
The trial is currently enrolling qualified patients. All patients involved in the study will undergo a marrow harvest in which stem cells will be taken from the marrow of their own hip bone. Then, during implantation of the LVAD, two thirds of the patients enrolled in the study will receive an injection of their own stem cells. A third of the patients will be randomly assigned to the control group, and will receive only an LVAD and an injection of saline.
The trial is double-blind, meaning U of M researchers will not know which patients have received stem cells and which did not until the trial concludes.
So far, three patients have enrolled. Researchers hope to eventually recruit 24 people from around the region. The study will last approximately two years.
In November, Magnuson became the first of the patients to have an LVAD implanted and receive an injection.
Throughout the trial, Magnuson and the other patients will undergo a series of tests in which doctors slowly decrease the effort of the LVAD and place more pressure back on the heart's own pumping function. The purpose of the tests is to assess the impact of the stem cells on restoring the functionality of heart muscle. Researchers want to know whether there is any improvement in the size of the heart and the pressure inside the heart chambers. The tests include echocardiograms, PET scans, walking assessments, blood pressure measurements and quality-of-life questioning.
Researchers will eventually compare the results of those tests to see if there was a difference between the two groups of patients.
"The hope is that this group of patients suffering from severe heart failure eventually should be able to get some cells and improve the heart function," said Dr. Raveendran.
That answer will come once the patients either undergo a transplant or they die. Only then will doctors be able to study the hearts to learn the true impact of the stem cells.
Last month, Magnuson was put on a waiting list for a heart transplant.
"So it's a matter of waiting now, it's a matter of time," explained Magnuson.
He remains optimistic about the future, but says his heart issues also have taught him to be a realist.
"My quality of life is, before it was work, work, work, and it's going to not be so much work anymore and we're going to enjoy things," reflected Magnuson. "You all of a sudden realize that you're not going to live forever."
To learn more about the study:
Call the U of M Physicians Heart at Fairview - 612-625-5949
Email - stemcells@umnheart.com
Webpage - http://www.med.umn.edu/lcru/
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U of M researchers aim to restore heart muscle using stem cells