$17.9 Million Grant for National Stem Cell Research

School of Public Health to lead national network seeking stem cell therapies for cardiovascular disease

Lemuel A. Moyé, M.D., Ph.D.

A new, $17.9 million grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health will make the Coordinating Center for Clinical Trials at The University of Texas School of Public Health the hub of a nationwide network conducting research on emerging stem cell-based treatments of cardiovascular disease.

"Over the next five years, the clinical centers will be carrying out a number of important stem cell research efforts," said principal investigator Lemuel A. Moyé, M.D., Ph.D., professor of biostatistics at the School of Public Health. "Our role is to coordinate that network and design, execute and analyze clinical protocols that constitute the early clinical phase of stem cell research."

A multicenter Cardiovascular Cell Therapy Research Network will be organized to conduct phase I and II collaborative clinical trials.

"We are excited to have this opportunity to participate in research to test the efficacy of stem cell therapy," said UT School of Public Health Dean Guy S. Parcel, Ph.D. "Our Coordinating Center for Clinical Trials has extensive experience in coordinating large clinical trials and looks forward to working with stem cell therapy researchers and the NIH to advance the knowledge base for this new type of medical treatment."

The coordinating center will provide leadership in several key areas: planning, developing and implementing the study design, research protocols, data acquisition procedures, study event identification and review, and quality control and training.

The UT M. D. Anderson Cancer Center will supply a core cell processing center, chemistry labs or imaging centers as necessary for selected studies. Principal investigator at their Cell Processing Laboratory is John D. McMannis, Ph.D., professor of stem cell transplantation.

As part of the project, a comprehensive public Web site will share information with professionals, the general public and study participants. A secure Web site will facilitate communications, data management and coordination among participating investigators, staff and institutions.

"The fact that our center was chosen is a reflection of our longstanding expertise in clinical trials, methodology and practice," Moyé said. "We are all honored to begin work with our esteemed colleagues at the entry level of stem cell research that will have broad implications for the cardiovascular community."

The school's Coordinating Center for Clinical Trials previously led a landmark multicenter study called the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), which was funded with a $103.2 million NHLBI grant in 1993. Results from the nationwide study involving 42,418 patients were published in December 2002 and concluded that lower-cost diuretics work better than or as well as more expensive, newer medications to treat high blood pressure and prevent heart disease.

UT School of Public Health co-investigators for the new Cardiovascular Cell Therapy Research Network project include: Robert J. Hardy, Ph.D., professor and director of the Division of Biostatistics; Mary Sarah Baraniuk, Ph.D., assistant professor, biostatistics; Leona K. Bartholomew, Ed.D., associate professor, health promotion and behavioral sciences; Charles E. Ford, Ph.D., associate professor, biostatistics; and Linda B. Piller, M.D., assistant professor, epidemiology.

By David R. Bates, Institutional Advancement