Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE)
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- Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non‐treatable Cardiac diseasE (SCIENCE)
Forlagets udgivne version, 4,89 MB, PDF-dokument
Christina Paitazoglou, Martin W Bergmann, Bojan Vrtovec, Steven A J Chamuleau, Bas van Klarenbosch, Wojtek Wojakowski, Aleksandra Michalewska-Włudarczyk, Mariann Gyöngyösi, Annette Ekblond, Mandana Haack-Sørensen, Kai Jaquet, Karsten Vrangbæk, Jens Kastrup, SCIENCE Investigators
AIMS: 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.
METHODS: 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 into viable myocardium in the infarct border zone using the NOGA XP system (BDS, Cordis, Johnson & Johnson, USA). Primary endpoint is a centralized core-laboratory assessed change in left ventricular end-systolic volume at 6-month follow-up measured by echocardiography. The trial started in January 2017, 58 patients were included and treated until July 2018.
CONCLUSION: The SCIENCE trial will provide clinical data on efficacy and safety of intramyocardial cell therapy of allogeneic adipose-derived stromal cells from healthy donors in patients with IHF.
|Tidsskrift||European Journal of Heart Failure|
|Status||Udgivet - 2019|
© 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
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