CARDIOVASCULAR CELL THERAPY RESEARCH NETWORK: NOT-HL-05-126
Purpose: This request is to announce the intention of the National Institutes of Health (NIH) to issue a request for applications (RFA) in the fall of 2005 to solicit grant applications for a cardiovascular cell therapy research network, with a receipt date for applications likely in the spring of 2006. This notice encourages investigators who believe that they have sufficient expertise and resources to participate in such a network to begin consideration of applying for this initiative. The network will initiate short-term phase I or II cell therapeutic protocols in cardiovascular disease patient populations to determine safety and efficacy.
The network will consist of clinical research centers and a data coordinating center. Clinical research centers, which will be responsible for proposing and developing clinical cell therapy protocols and conducting the clinical studies, must demonstrate clinical science excellence, a background in cell therapy research, a proven ability to recruit cardiovascular disease patients, and the capability to isolate and prepare clinical grade cell products. All individual clinical research centers are required to participate in a cooperative and interactive manner with one another and with the data coordinating center. The data coordinating center will coordinate all phases of multicenter clinical studies, protocol and manual of operations development, data collection and management, data safety and confidentiality, adverse events, quality assurance, data analysis, distributed data entry, electronic communications, and administrative management and coordination. The data coordinating center will also provide regulatory guidance and facilitate interactions with regulatory authorities. The same institution may apply for both a clinical research center and the data coordinating center award, but the applications for each must be from different individuals and must be submitted as separate applications.
The network is based on the recommendations of the National Heart, Lung, and Blood Institute (NHLBI) Working Group “Translation of Cardiovascular Cell Based …