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. 2010 Feb;3(1):30-6.
doi: 10.1007/s12265-009-9160-3.

Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN)

Robert D Simari  1 , Lemuel A Moyé, Sonia I Skarlatos, Stephen G Ellis, David X M Zhao, James T Willerson, Timothy D Henry, Carl J Pepine
Affiliations

Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN)

Robert D Simari et al. J Cardiovasc Transl Res. 2010 Feb.

Abstract

The emerging sciences of stem cell biology and cellular plasticity have led to the development of cell-based therapies for advanced human disease. Pre-clinical studies which defined the potential of bone marrow-derived mononuclear cells to repair damaged and dysfunctional myocardium led to the rapid advancement of these strategies to the clinic. Such rapid advancement has led to controversy regarding the appropriate conduct of such studies. In the United States, the National Heart, Lung, and Blood Institute established the Cardiovascular Cell Therapy Research Network (CCTRN) to facilitate the early translation of clinical trials of cell therapy for left ventricular dysfunction. The premise upon which the CCTRN was established was that multiple clinical trial sites would interact effectively with a Data Coordinating Center to perform early phase 1 and 2 clinical trials within a highly coordinated network structure. In order to develop this network, the unmet needs of the community needed to be defined, the clinical trials identified, and the structure to perform the studies needed to be established. This manuscript highlights the challenges in the development of the CCTRN and the approaches faced to define a network to perform clinical trials in human cell therapy of cardiovascular disease.

Keywords: Biorepository; Cell Therapy; Management; Multicenter; Network.

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Figures

Fig. 1
Fig. 1
Organizational structure of the CCTRN. PRC Protocol Review Committee, DSMB Data Safety and Monitoring Board
Fig. 2
Fig. 2
Map of CCTRN sites. Clinical Centers: 1 Cleveland Clinic, Cleveland, Ohio; 2 Texas Heart Institute; 3 University of Florida at Gainesville, Gainesville, Florida; 4 Minneapolis Heart Institute, Minneapolis, Minnesota; 5 Vanderbilt University Medical Center, Nashville, Tennessee; 6 Study Sponsor, NHLBI Bethesda, Maryland; 7 Data Coordinating Center, Houston, Texas; 8 Bio-Repository, Minneapolis, Minnesota; 9 Bio-Repository, Gainesville, Florida; 10 Echo Core Lab, Cleveland, Ohio; 11 MRI Core Lab, Gainesville, Florida; 12 MV02 Core Lab, Gainesville, Florida; 13 SPECT Core Lab, Nashville, Tennessee; 14 Cell Processing Quality Control Lab, Houston, Texas
Fig. 3
Fig. 3
Placebo preparation. Autologous blood is added to 5% serum albumen to create a blinded preparation
See this image and copyright information in PMC

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