The Coordinating Center for Clinical Trials at The University of Texas School of Public Health has received a new, $17.9 million grant to serve as the hub of a nationwide network conducting research on emerging stem cell-based treatments of cardiovascular disease.
Funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, the five-year grant runs through 2011.
“We are excited to have this opportunity to participate in research to test the efficacy of stem cell therapy. 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,” said UT School of Public Health Dean Guy S. Parcel, Ph.D.
A multicenter Cardiovascular Cell Therapy Research Network (CCTRN) will be organized to conduct phase I and II collaborative clinical trials.
The UT School of Public Health’s Coordinating Center for Clinical Trials (CCCT) in the Texas Medical Center will select and oversee a core cell processing center, chemistry labs or imaging centers in support of the selected studies.
“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 UT 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.”
The CCCT will provide leadership in several key areas: planning and developing the study design, organization and operations; developing and implementing research protocols, detailed manuals of operations and suitable analytical and statistical methodology for each investigation; creating appropriate data acquisition procedures and forms; setting procedures for study event identification, abstraction and review; and, maintaining quality control and training.
The University of Texas 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 for the cardiovascular community.”