Notice Number: NOT-HL-05-126
Release Date: July 13, 2005
The purpose of this Notice is to announce the NIH's intention 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 RFA will stipulate that:
1. The Network will initiate short-term Phase I or II cell therapeutic protocols in cardiovascular disease patient populations to determine safety and efficacy. Protocols will be rigorously evaluated prior to implementation and will utilize standardized cell preparations.
2. The Network will consist of Clinical Research Centers and a Data Coordinating Center.
3. 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 Centers are required to participate in a cooperative and interactive manner with one another and with the Data Coordinating Center.
4. The Data Coordinating Center will coordinate all phases of multi-center 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.
5. The same institution may apply for both a Clinical 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 upon the recommendations of the NHLBI Working Group “Translation of Cardiovascular Cell Based Therapies,” which met on August 5-6, 2004. An interim summary report is available at: http://www.nhlbi.nih.gov/meetings/workshops/translation.htm.
After the RFA is issued, a pre-submission meeting will be conducted in Bethesda, Maryland, to which all prospective applicants are invited. At the meeting, presentations by NHLBI and other NIH staff will be provided to explain the goals and objectives of the Cardiovascular Cell Therapy Research Network and to answer questions. We anticipate this meeting will be held in the fall of 2005 and that information from the meeting will be available on the NHLBI web site shortly after that.
APPLICATIONS ARE NOT BEING REQUESTED AT THIS TIME.
Interested parties may contact:
John Fakunding, Ph.D.
Director, Heart Research Program
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 9170, MSC 7940
6701 Rockledge Drive
Bethesda, MD 20892-7940
Telephone: (301) 435-0544
FAX: (301) 480-1336
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.