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Eur J Heart Fail. 2019 Aug;21(8):1032-1041. doi: 10.1002/ejhf.1412. Epub 2019 Feb 20.

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

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Department of Cardiology, Cardiologicum Hamburg, Hamburg, Germany.
Advanced Heart Failure and Transplantation Center, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Department of Cardiology and Regenerative Medicine Center, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
Department of Cardiology, Medical University of Vienna, Vienna, Austria.
Department of Cardiology and Cardiology Stem Cell Centre, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.
Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
Faculty of Social Sciences and the Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.



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 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.


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.


Adipose-derived stromal cells; Allogeneic therapy; Clinical trial; Heart failure; Ischaemic cardiomyopathy; Stem cells


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