Insights into therapeutic products, preclinical research models, and clinical trials in cardiac regenerative and reparative medicine: where are we now and the way ahead. Current opinion paper of the ESC Working Group on Cardiovascular Regenerative and Reparative Medicine
Por:
Grigorian-Shamagian, L, Sanz-Ruiz, R, Climent, A, Badimon, L, Barile, L, Bolli, R, Chamuleau, S, Grobbee, DE, Janssens, S, Kastrup, J, Kragten-Tabatabaie, L, Madonna, R, Mathur, A, Menasche, P, Pompilio, G, Prosper, F, Sena, E, Smart, N, Zimmermann, WH, Fernandez-Aviles, F
Publicada:
1 jun 2021
Resumen:
Great expectations have been set around the clinical potential of regenerative and reparative medicine in the treatment of cardiovascular diseases [i.e. in particular, heart failure (HF)]. Initial excitement, spurred by encouraging preclinical data, resulted in a rapid translation into clinical research. The sobering outcome of the resulting clinical trials suggests that preclinical testing may have been insufficient to predict clinical outcome. A number of barriers for clinical translation include the inherent variability of the biological products and difficulties to develop potency and quality assays, insufficient rigour of the preclinical research and reproducibility of the results, manufacturing challenges, and scientific irregularities reported in the last years. The failure to achieve clinical success led to an increased scrutiny and scepticism as to the clinical readiness of stem cells and gene therapy products among clinicians, industry stakeholders, and funding bodies. The present impasse has attracted the attention of some of the most active research groups in the field, which were then summoned to analyse the position of the field and tasked to develop a strategy, to re-visit the undoubtedly promising future of cardiovascular regenerative and reparative medicine, based on lessons learned over the past two decades. During the scientific retreat of the ESC Working Group on Cardiovascular Regenerative and Reparative Medicine (CARE) in November 2018, the most relevant and timely research aspects in regenerative and/or reparative medicine were presented and critically discussed, with the aim to lay out a strategy for the future development of the field. We report herein the main ideas and conclusions of that meeting.
Filiaciones:
Grigorian-Shamagian, L:
Univ Complutense, Hosp Gen Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon, Dept Cardiol, Doctor Esquerdo 46, Madrid 28007, Spain
Inst Salud Carlos III, CIBERCV, Madrid, Spain
Sanz-Ruiz, R:
Univ Complutense, Hosp Gen Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon, Dept Cardiol, Doctor Esquerdo 46, Madrid 28007, Spain
Inst Salud Carlos III, CIBERCV, Madrid, Spain
Climent, A:
Univ Complutense, Hosp Gen Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon, Dept Cardiol, Doctor Esquerdo 46, Madrid 28007, Spain
Inst Salud Carlos III, CIBERCV, Madrid, Spain
Badimon, L:
Inst Salud Carlos III, CIBERCV, Madrid, Spain
Autonomous Univ Barcelona, Cardiovasc Program ICCC, IR Hosp Santa Creu & St Pau, Barcelona, Spain
Autonomous Univ Barcelona, Cardiovasc Res Chair, Barcelona, Spain
Barile, L:
Cardioctr Ticino Fdn, Lab Cardiovasc Theranost, Lugano, Switzerland
Univ Svizzera Italiana, Fac Biomed Sci, Lugano, Switzerland
Bolli, R:
Univ Louisville, Inst Mol Cardiol, ACB, 550 S Jackson St,3rd Floor, Louisville, KY 40292 USA
Chamuleau, S:
Amsterdam UMC, Dept Cardiol, Location AMC, B2-239,Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands
Grobbee, DE:
Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands
Janssens, S:
UZ Leuven, Dept Cardiovasc Med, Campus Gasthuisberg,Herestr 49, B-3000 Leuven, Belgium
Kastrup, J:
Univ Copenhagen, Heart Ctr, Dept Cardiol, Rigshosp, Copenhagen, Denmark
Kragten-Tabatabaie, L:
Julius Clin, Zeist, Netherlands
Madonna, R:
Univ Pisa, Inst Cardiol, Pisa, Italy
Mathur, A:
Queen Mary Univ London, Ctr Cardiovasc Med & Device Innovat, Barts Heart Ctr, St Bartholomews Hosp, London, England
Menasche, P:
Univ Paris, Dept Cardiovasc Surg, Hop Europeen Georges Pompidou 20, PARCC,INSERM, Rue Leblanc, F-75015 Paris, France
Pompilio, G:
Ctr Cardiol Monzino IRCCS, Pompilio G Vasc Biol & Regenerat Med Unit, Milan, Italy
Univ Milan, Dept Clin Sci & Community Hlth, Milan, Italy
Prosper, F:
Inst Salud Carlos III, Clin Univ Navarra Pamplona & Tercel, Hematol & Cell Therapy, Madrid, Spain
Sena, E:
Univ Edinburgh, Ctr Clin Brain Sci, Edinburgh, Midlothian, Scotland
Smart, N:
Univ Oxford, Dept Physiol Anat & Genet, Oxford, England
Zimmermann, WH:
Georg August Univ, Univ Med Ctr, Inst Pharmacol & Toxicol, Gottingen, Germany
DZHK German Ctr Cardiovasc Res, Partner Site Gottingen, Potsdamer Str 58, D-10785 Berlin, Germany
Fernandez-Aviles, F:
Univ Complutense, Hosp Gen Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon, Dept Cardiol, Doctor Esquerdo 46, Madrid 28007, Spain
Inst Salud Carlos III, CIBERCV, Madrid, Spain
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