UF key to heart study network

The $33.7 million research group will study treatment with stem cells.

Published: Monday, January 29, 2007 at 10:52 a.m.
Last Modified: Monday, January 29, 2007 at 10:52 a.m.

University of Florida researchers will play a key role in a new national network designed to study stem cell treatments in patients with cardiovascular disease.

When you consider that one-third of all Americans die of heart disease, it may be promising news that stem cell research may soon offer other treatment options.

UF will join four other research centers the Cleveland Clinic, the Texas Heart Institute, the University of Minnesota and Vanderbilt University this spring as part of a national consortium known as the Cardiovascular Cell Therapy Research Network, seeking to identify and test new cell therapies to improve the structure and function of the heart and its blood vessels.

The consortium's projects will be supported by a grant from the National Heart, Lung and Blood Institute that is expected to total $33.7 million over the next five years. At least 10 studies are planned during the funding period.

"Most of us believe that some form of regenerative medicine will be the future for treatment of cardiovascular disease, that it will be the next level of care," said Dr. Carl J. Pepine, professor and chief of cardiovascular medicine in UF's College of Medicine and the principal investigator and center director for the UF site.

According to Pepine, considerable work on stem cell treatment and heart disease has been done in Europe and some other countries over the past 2 years, but very little in the United States.

"It is very expensive and the regulatory issues are complicated proving to the Food and Drug Administration that the stem cells are safe to give a human patient," he said. "Being able to do the research requires a very large team of people. Put all that together and the most feasible approach is to put together a network of a small number of centers with the expertise to do this."

With that expertise, according to Pepine, large numbers of patients can be enrolled in a clinical trial, the costs can be shared and a successful approach "can move forward into the clinic quickly."

"We all believe this is the next horizon in cardiovascular therapeutics, enhancing a patient's own cells so that they work even better," he said. "There is an evolving record over the past 10 years that is very encouraging for those of us in the field."

Researchers will focus on adults with coronary artery disease, congestive heart failure or other conditions, including diabetes, that reduce blood flow to the heart, damaging heart muscle and hampering its ability to function properly. Studies will test whether various cell therapies can improve the heart's plumbing by helping to repair blood vessels or form new ones and strengthen the heart muscle to improve its ability to pump efficiently.

When part of the heart is deprived of its blood supply, the result can be a heart attack. The patient may recover, but the muscle tissue of the heart can be left permanently scarred.

"These will be patients who have already had medical therapy bypass surgery, angioplasty, stents or other treatment options and have not responded," Pepine said. "The current thinking is we have a limited capacity to repair our hearts and blood vessels but even that is somehow defective in people who have end-stage disease. Our hope is that by providing new cells we may be able to restore the reparative process."

The first two studies will involve stem cells harvested from the patient's own bone marrow, where a lifetime's worth of new cells are generated. The selected cells will be injected back into the coronary arteries. The goal is to grow new capillaries and small arteries.

In a second study, harvested stem cells will be injected into areas of heart muscle that have been damaged. The goal will be to grow new muscle cells, each with the ability to contract and repair the damaged tissue.

These are not the embryonic stem cells that have generated recent ethical debate.

The body has a reservoir of stem cells that have no fixed identity. Instead, one of these stem cells can give rise to many types of cells. When it divides, it produces two cells with different fates: One will remain a stem cell and the other will go on to specialize in any one of more than 200 different cell types in the body heart, muscle, liver, kidney and so forth.

Initially, each of the five centers will recruit 60 to 100 patients for two research trials to launch early this year. Patients will be followed for a year. UF has assembled a team of 10 scientists in various disciplines to be part of the project.

Another study proposed by UF researchers involves extracting skeletal muscle cells from the thigh in patients with severe heart failure who are awaiting heart transplantation. The cells would be multiplied in tissue culture and then implanted directly into the same patient's heart. The goal would be to determine whether the cells can strengthen a very weakened heart and determine how long the cells survive, said Dr. Daniel Pauly, an associate professor of medicine and director of the division of cardiovascular medicine's molecular cardiology and genetics section.

In all, 10 projects have been proposed, each taking a slightly different approach to the problem. The consortium members will meet in New Orleans in March to complete the planned studies, according to Pepine.

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