December 15, 2006

VUMC joins cell therapy network

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Advanced treatment options, including the use of stem-cell based therapies, have proven to restore injured and/or lost cardiac tissue to improve heart function.

VUMC joins cell therapy network

Vanderbilt University Medical Center has been named one of the founding institutions of a network developed by the National Institutes of Health to “study and define cell-based therapies.”

The program, the Cardiac Cell Therapy Research Network, is sponsored by the National Heart Lung and Blood Institute (NHLBI), and is expected to launch the United States into the international field of cardiac regenerative therapy

The network will implement phase 2 studies in patients with cardiac disease to explore the effects of cell therapies on the regeneration of the heart muscle.

“This network will definitely put the United States on the map concerning cell-based therapies,” said Doug Vaughan, M.D., chief of Cardiovascular Medicine and principal investigator. “It will also serve as a platform and springboard for Vanderbilt to get involved in cell-based therapies down the road. Just because we are delivering cells to the heart doesn't mean we can't learn to use similar therapies for bone disease, diabetes and so on.

“Individual hospitals and single medical schools will find it very hard to develop cell-based programs on their own because of the regulatory hurdles and FDA requirements,” he said. “This network will have the distinct advantage and opportunity to study and define cell-based therapies of all forms for our country.”

Vaughan said the United States is behind countries in Europe, Asia and South America in the study and the use of the novel therapeutic approach.

The grant awards Vanderbilt approximately $1M a year for five years to participate in the study along with Texas Heart, University of Minnesota, University of Florida and Cleveland Clinic.

Recently, Vanderbilt was named as one of three centers in the country to begin Phase 1 clinical trials using bone marrow stem cells to assist the recovery and regeneration of heart muscle following a heart attack. The trial, which began in November, is sponsored by a privately-funded cell-therapy company in New Jersey called Amorcyte. The other two sites participating include Texas Heart and Emory University in Atlanta.

The premise behind cardiac regenerative therapy is this: Bone marrow is rich in endothelial progenitor cells thought to facilitate the growth of new blood vessels and augment the function of the heart. A patient's stem cells will be collected and later infused through a catheter into the coronary artery or directly into the heart's muscle.

Vaughan said his team is excited about both opportunities.

“The Amorcyte study allows Vanderbilt to get our toes into the water with cell-therapy while the NIH trial really gets us into the swimming pool.”

In 2005, the NIH began creating a consortium of top-class medical centers to investigate the use of cell-based therapies in the treatment of cardiac disease. About 30 centers applied for the five spots.

Heart disease is the leading cause of death in the United States. Approximately 1 million new cases of congestive heart failure (CHF) are diagnosed each year; 5 million people suffer from heart failure and nearly 2 million die each year.

“In spite of the numerous advances in the prevention and treatment of CHF, the median five-year survival after diagnosis is less than 50 percent,” said Antonis Hatzopoulos, Ph.D., associate professor of Medicine and Cell and Developmental Biology. “At this time there are no ways to reverse the course of the disease. Cell therapy to replace or rejuvenate damaged cardiac tissue has the potential to improve the quality of life for millions of patients.”

Hatzopoulos, Vanderbilt's co-principal investigator, said the grant award highlights the medical center's leadership in cardiovascular medicine as well as its high-level of clinical and scientific talent.

A 2005 recruit from Munich, Germany, Hatzopoulos has more than 10 years of experience in this area of research. His lab has been studying pre-clinical disease models in mice, rabbits and pigs to provide a better understanding of how stem cells work in hopes of optimizing the design of cell-therapy protocols.

Vanderbilt has several established research programs in cell-regeneration therapy, but this grant places the institution “at the forefront of exciting new research,” said Friedrich Schuening, M.D., chief Section of Hematology and Stem Cell Transplant.

David Zhao, M.D., Ph.D., director of the Cardiac Cath Lab said Vanderbilt's selection into the network will help recognize “us as a leading center for cell-based therapies in heart patients and provide resources and expertise from all over the country.”

The network steering committee is in the process of developing protocols for potentially two Phase 2 studies with a projected start date of mid 2007. Nearly 200 patients are expected to participate in each study.