Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE)

European Journal of Heart Failure
Christina PaitazoglouSCIENCE Investigators

Abstract

Ischaemic heart failure (IHF) patients have a poor prognosis even with current guideline-derived therapy. Intramyocardial injections of autologous or allogeneic mesenchymal stromal cells might improve cardiac function leading to better clinical outcome. The SCIENCE (Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE) consortium has initiated a Horizon 2020 funded multicentre phase II study in six European countries. It is a double-blind, placebo-controlled trial testing the safety and efficacy of allogeneic Cardiology Stem Cell Centre Adipose-derived Stromal Cells (CSCC_ASC) from healthy donors or placebo in 138 symptomatic IHF patients. Main inclusion criteria are New York Heart Association class II-III, left ventricular ejection fraction < 45% and N-terminal pro-B-type natriuretic peptide levels > 300 pg/mL. Patients are randomized in a 2:1 pattern to receive intramyocardial injections of either CSCC_ASC or placebo. CSCC_ASC and placebo treatments are prepared centralized at Rigshospitalet in 5 mL vials as an off-the-shelf product. Vials are distributed to all clinical partners and stored in nitrogen vapour tanks ready to be used directly after thawing. A total of 100 × 106 CSCC_ASC or placebo are injected directly i...Continue Reading

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Citations

May 29, 2020·European Journal of Heart Failure·Marianna AdamoMarco Metra
Jul 25, 2019·Journal of Cardiovascular Translational Research·Hans Thijs van den BroekRené van Es
Apr 3, 2020·Transplant International : Official Journal of the European Society for Organ Transplantation·Martin J HoogduijnMarlies E J Reinders
Aug 13, 2020·Current Heart Failure Reports·Gregor PoglajenBojan Vrtovec
Dec 6, 2020·ESC Heart Failure·Daniela TomasoniMarco Metra
Oct 26, 2020·European Heart Journal·Roberto Bolli
May 3, 2020·Current Stem Cell Research & Therapy·Saeideh Gholamzadeh KhoeiMohsen Sheykhhasan
Apr 4, 2021·Cells·Thomas J Povsic, Bernard J Gersh
Apr 20, 2021·Cardiovascular Research·Roberto BolliArunpreet Kahlon

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BETA
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