Endpoints in stem cell trials in ischemic heart failure

Marko Banovic, Zlatibor Loncar, Atta Behfar, Marc Vanderheyden, Branko Beleslin, Andreas Zeiher, Marco Metra, Andre Terzic, Jozef Bartunek

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Despite multimodal regimens and diverse treatment options alleviating disease symptoms, morbidity and mortality associated with advanced ischemic heart failure remain high. Recently, technological innovation has led to the development of regenerative therapeutic interventions aimed at halting or reversing the vicious cycle of heart failure progression. Driven by the unmet patient need and fueled by encouraging experimental studies, stem cell-based clinical trials have been launched over the past decade. Collectively, these trials have enrolled several thousand patients and demonstrated the clinical feasibility and safety of cell-based interventions. However, the totality of evidence supporting their efficacy in ischemic heart failure remains limited. Experience from the early randomized stem cell clinical trials underscores the key points in trial design ranging from adequate hypothesis formulation to selection of the optimal patient population, cell type and delivery route. Importantly, to translate the unprecedented promise of regenerative biotherapies into clinical benefit, it is crucial to ensure the appropriate choice of endpoints along the regulatory path. Accordingly, we here provide considerations relevant to the choice of endpoints for regenerative clinical trials in the ischemic heart failure setting.

Original languageEnglish (US)
Article number159
JournalStem Cell Research and Therapy
Volume6
Issue number1
DOIs
StatePublished - Aug 29 2015

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Stem cells
Stem Cells
Heart Failure
Clinical Trials
Inventions
Biological Therapy
Patient Selection
Innovation
Morbidity
Safety
Mortality
Therapeutics
Population

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology (miscellaneous)
  • Molecular Medicine
  • Cell Biology
  • Medicine (miscellaneous)

Cite this

Banovic, M., Loncar, Z., Behfar, A., Vanderheyden, M., Beleslin, B., Zeiher, A., ... Bartunek, J. (2015). Endpoints in stem cell trials in ischemic heart failure. Stem Cell Research and Therapy, 6(1), [159]. https://doi.org/10.1186/s13287-015-0143-9

Endpoints in stem cell trials in ischemic heart failure. / Banovic, Marko; Loncar, Zlatibor; Behfar, Atta; Vanderheyden, Marc; Beleslin, Branko; Zeiher, Andreas; Metra, Marco; Terzic, Andre; Bartunek, Jozef.

In: Stem Cell Research and Therapy, Vol. 6, No. 1, 159, 29.08.2015.

Research output: Contribution to journalArticle

Banovic, M, Loncar, Z, Behfar, A, Vanderheyden, M, Beleslin, B, Zeiher, A, Metra, M, Terzic, A & Bartunek, J 2015, 'Endpoints in stem cell trials in ischemic heart failure', Stem Cell Research and Therapy, vol. 6, no. 1, 159. https://doi.org/10.1186/s13287-015-0143-9
Banovic M, Loncar Z, Behfar A, Vanderheyden M, Beleslin B, Zeiher A et al. Endpoints in stem cell trials in ischemic heart failure. Stem Cell Research and Therapy. 2015 Aug 29;6(1). 159. https://doi.org/10.1186/s13287-015-0143-9
Banovic, Marko ; Loncar, Zlatibor ; Behfar, Atta ; Vanderheyden, Marc ; Beleslin, Branko ; Zeiher, Andreas ; Metra, Marco ; Terzic, Andre ; Bartunek, Jozef. / Endpoints in stem cell trials in ischemic heart failure. In: Stem Cell Research and Therapy. 2015 ; Vol. 6, No. 1.
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