David Zhao, M.D., right, and members of the stem cell surgical team, from left, Ricky Woodard, Jeff Rottman, M.D., and Scott Philips, M.D. (photo by Anne Rayner)
Novel stem cell trial targets heart disease
Vanderbilt Heart & Vascular Institute recently enrolled its first patient in the FOCUS clinical trial in hopes of reversing damage to the patient's cardiac muscle caused by heart disease.
FOCUS is one of three trials currently being conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), a network of physicians, scientists and support staff dedicated to studying stem cell therapy for treating heart disease.
The CCTRN is funded by the National Institutes of Health (NIH) and includes researchers at five stem cell centers in the United States.
FOCUS is a Phase II clinical trial evaluating the effects of autologous bone marrow mononuclear cells for patients with chronic ischemic heart disease and left ventricular dysfunction.
David Zhao, M.D., director of the cardiac catheterization lab and Interventional Cardiology, treated a 65-year-old heart failure patient by taking a bone marrow sample from the patient's hip bone. He then injected adult stem cells, which he selected from the bone marrow, into the patient's heart using the NOGA guidance system to place cells directly in the patient's damaged heart muscle.
“The stem cells do not go through the coronary arteries; they go directly into the heart muscle. This provides a high concentration in an area that needs cells instead of getting flushed out by the blood flow in the arteries,” Zhao said.
Recent studies are investigating whether bone marrow cells that are injected into the heart muscle are able to promote blood vessel and heart muscle growth that will improve the blood supply to the heart and the heart's ability to pump blood.
The purpose of this study is to determine the safety and effectiveness of this technique in people who are not ideal candidates for other forms of standard therapy such as surgery or use of standard catheter-based techniques such as balloon angioplasty or stent placement, according to the CCTRN.
“The patients who stand to benefit from this approach include those whose coronary arteries are so diseased that nothing else could be done,” Zhao said. “These patients have poor outcomes, depressed heart function, heart failure and chest pain. Their life expectancy is reduced, and their quality of life is jeopardized.”
Patients who enroll in FOCUS will have follow up with the Vanderbilt team including MRI and nuclear imaging studies, modalities to examine ischemia, cardiac function and contractility, and clinical outcomes to see whether the patient's condition has improved.
Working with Zhao on the FOCUS trial is Jeff Rottman, M.D., Marvin Kronenberg, M.D., Allen Naftilan, M.D., Scott Philips, M.D., Judy Francescon, R.N., and Sherry Bowman, R.N. The bone marrow stem cell harvest and processing team includes Friedrich Schuening, M.D., Adetola Kassim, M.D., Catherine Lucid, Karen Prater, Dorinda Halteman and Have Fife.