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Circ Res. 2018 Jan 19;122(2):310-318. doi: 10.1161/CIRCRESAHA.117.311565.

Translational Research in Cardiovascular Repair: A Call for a Paradigm Shift.

Author information

1
From the Department of Cardiology (S.A.J.C., M.v.d.N., A.O.K.) and Regenerative Medicine Center Utrecht (S.A.J.C., M.v.d.N.), University Medical Center Utrecht, The Netherlands; European Society of Cardiology Working Group on Cardiovascular Regenerative and Reparative Medicine (CARE), Biot, France (S.A.J.C., A.M.C., F.F.-A.); Department of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense, CIBERCV, Madrid, Spain (A.M.C., F.F.-A.); Department of Health Evidence, SYRCLE, Radboud University Medical Center, Nijmegen, The Netherlands (K.E.W.); Division of Experimental Cardiology, Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands (D.J.D.); The Netherlands Heart Institute, Utrecht (D.J.D.); and Division of Cardiology, Department of Medicine, Institute of Molecular Cardiology, University of Louisville, KY (R.B.). s.a.j.chamuleau@umcutrecht.nl.
2
From the Department of Cardiology (S.A.J.C., M.v.d.N., A.O.K.) and Regenerative Medicine Center Utrecht (S.A.J.C., M.v.d.N.), University Medical Center Utrecht, The Netherlands; European Society of Cardiology Working Group on Cardiovascular Regenerative and Reparative Medicine (CARE), Biot, France (S.A.J.C., A.M.C., F.F.-A.); Department of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense, CIBERCV, Madrid, Spain (A.M.C., F.F.-A.); Department of Health Evidence, SYRCLE, Radboud University Medical Center, Nijmegen, The Netherlands (K.E.W.); Division of Experimental Cardiology, Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands (D.J.D.); The Netherlands Heart Institute, Utrecht (D.J.D.); and Division of Cardiology, Department of Medicine, Institute of Molecular Cardiology, University of Louisville, KY (R.B.).

Abstract

The international consortium TACTICS (Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes) has recently addressed key priorities in the field of cell-based therapy for cardiac repair, identifying the efficacy of translational research as one of the main challenges to ultimately improve the quality of life of patients with ischemic disease. Much of the controversy and confusion surrounding cardiac regenerative therapy stems from insufficient rigor in the conduct of preclinical studies, and there is an increasing recognition of a number of problems that undermine its quality that may contribute to translational failure. Here, we introduce well defined stages for preclinical research, and put forth proposals that should promote more rigorous preclinical work, in an effort to improve its quality and translatability. To augment the utility of preclinical research and its translation, it is necessary to (1) improve the quality of preclinical research, (2) promote collaborative efforts, and (3) enhance the sharing of knowledge and protocols. In particular, confirmatory (stage III) preclinical studies should be considered as a preamble to clinical studies and therefore must adhere to their standards of quality (including internal validity, standardization of protocols, and multicenter design). To increase transparency and minimize bias, these studies should be prospectively registered in an independent, open database. Ultimately, these recommendations should be implemented in the daily routine of investigators and in the policies of institutions, journals, and funding agencies.

KEYWORDS:

animal experimentation; research design; stem cell research; translational medical research

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