Endpoints in stem cell trials in ischemic heart failure

Stem Cell Research & Therapy
Marko BanovicJozef Bartunek

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...Continue Reading

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Citations

Apr 9, 2017·Molecular Therapy : the Journal of the American Society of Gene Therapy·Seppo Ylä-Herttuala, Andrew H Baker
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Jul 15, 2018·Journal of the American Heart Association·Bryon A TompkinsJoshua M Hare
Apr 3, 2020·Current Topics in Medicinal Chemistry·Marko BanovicSerge D Nikolic
Sep 22, 2020·Nuclear Medicine and Biology·Aditya BansalTimothy R DeGrado

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