Five centers chosen for cell therapy research

NHLBI’s new Cardiovascular Cell Therapy Research Network strives to advance the field of stem cell-based therapies for CVDs.

The National Heart, Lung, and Blood Institute has funded the centers and a data coordinating center for its new Cardiovascular Cell Therapy Research Network.

Clinical centers of the Cardiovascular Cell Therapy Research Network (CCTRN) include: Cleveland Clinic, Stephen Ellis, MD, primary investigator; Texas Heart Institute, James Willerson, MD, PI; University of Florida, Gainesville, Carl J. Pepine, MD, PI; University of Minnesota, Timothy Henry, MD, PI; and Vanderbilt University, Douglas Vaughan, MD, PI. The data coordinating center is University of Texas Health Science Center at San Antonio.

The five participating centers will receive $33.7 million over five years to identify and test new cell therapies to improve the structure and function of the heart and its blood vessels; nearly $5 million will be disbursed this year.

“We hope to be a voice of balance and innovation within the field,” said steering committee chair Robert Simari, MD, also professor of medicine and chair of cardiovascular research at the Mayo Clinic, Rochester, Minn., in an interview. “The centers that are participating and were funded are absolutely delighted to be involved and excited to participate as a network. Our goal is really to become indispensable in the field as the mechanism for the thoughtful translation of cell therapy.”

Moving research forward

Vaughan, chief of cardiovascular medicine at Vanderbilt University and member of the Vascular Biology section of Today in Cardiology’s editorial board, said that the CCTRN participating centers would conduct trials of cell-based therapy for the treatment of cardiac dysfunction.

“The network is really going to drive the study and application of cell-based therapy for heart disease in this country,” Vaughan said, adding that there are already several ongoing studies around the United States, unrelated to the network.

In the grant filing, the NHLBI said: “The emphasis will be on early phase-1 and phase-2 clinical investigations that help identify optimal cell therapy to improve ventricular function and structure. Therapeutic studies may involve autologous and allogeneic cells, new strategies for cell delivery, techniques for screening and localizing transplanted cells, and standardization of cell and therapeutic procedures.”

Pepine, Today in Cardiology’s chief medical editor, and eminent scholar, professor and chief, division of cardiovascular medicine at University of Florida, Gainesville, said that the study population will include adults with CAD, CHF, or other conditions including diabetes that reduce blood flow to the heart, damaging heart muscle and hampering proper function.

“Many of these are likely to be patients who have already had medical therapy, bypass surgery, angioplasty, stents or other treatment options and have not responded to those treatments,” Pepine said.

Phase-3 trials are not included in the program. Simari said it is too early to identify the first projects the centers will undertake, although after the CCTRN’s first meeting last month, Pepine said there would likely be about 10 studies conducted.

The network will be interactive with practicing cardiologists, with a Web site that is not yet ready, Simari and Vaughan said. Cardiologists can refer appropriate patients to participate in network trials, Vaughan said.

“This network will provide an outlet for patients and physicians, if they meet entry criteria for a study, [they might be able] to participate and help advance the field,” Vaughan said. – by Judith Rusk