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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).

Author information

1
Department of Cardiology, Cardiologicum Hamburg, Hamburg, Germany.
2
Advanced Heart Failure and Transplantation Center, University Medical Centre Ljubljana, Ljubljana, Slovenia.
3
Department of Cardiology and Regenerative Medicine Center, University Medical Center Utrecht, Utrecht, The Netherlands.
4
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
5
Department of Cardiology, Medical University of Vienna, Vienna, Austria.
6
Department of Cardiology and Cardiology Stem Cell Centre, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.
7
Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
8
Faculty of Social Sciences and the Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.

Abstract

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.

KEYWORDS:

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

PMID:
30790396
DOI:
10.1002/ejhf.1412

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