title: Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN).
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.
authors.affiliation: Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Simari
authors.forename: Lemuel A
authors.initials: LA
authors.lastname: Moyé
authors.forename: Sonia I
authors.initials: SI
authors.lastname: Skarlatos
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.forename: David X M
authors.initials: DX
authors.lastname: Zhao
authors.forename: James T
authors.initials: JT
authors.lastname: Willerson
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Henry
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Pepine
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D003299:Cooperative Behavior; D019317:Evidence-Based Medicine; D006801:Humans; D007373:Interinstitutional Relations; D015337:Multicenter Studies as Topic; D054555:National Heart, Lung, and Blood Institute (U.S.) / Q000458:organization & administration*; D009937:Organizational Objectives; D017410:Practice Guidelines as Topic; D016730:Program Development; D020127:Recovery of Function; D012107:Research Design; D033581:Stem Cell Transplantation; D057170:Translational Research, Biomedical / Q000458:organization & administration*; D016896:Treatment Outcome; D014481:United States; D018487:Ventricular Dysfunction, Left / Q000503:physiopathology / Q000601:surgery*; D016277:Ventricular Function, Left
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