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

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

doi:10.1002/ejhf.1412

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

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

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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.

Original language	English
Journal	European Journal of Heart Failure
Volume	21
Issue number	8
Pages (from-to)	1032-1041
Number of pages	10
ISSN	1388-9842
DOIs	https://doi.org/10.1002/ejhf.1412
Publication status	Published - Aug 2019

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Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non‐treatable Cardiac diseasE (SCIENCE)Final published version, 4.89 MBLicence: CC BY

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Paitazoglou, C., Bergmann, M. W., Vrtovec, B., Chamuleau, S. A. J., van Klarenbosch, B., Wojakowski, W., Michalewska-Włudarczyk, A., Gyöngyösi, M., Ekblond, A., Haack-Sørensen, M., Jaquet, K., Vrangbæk, K., Kastrup, J., & SCIENCE Investigators (2019). Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE). European Journal of Heart Failure, 21(8), 1032-1041. https://doi.org/10.1002/ejhf.1412

Paitazoglou, C, Bergmann, MW, Vrtovec, B, Chamuleau, SAJ, van Klarenbosch, B, Wojakowski, W, Michalewska-Włudarczyk, A, Gyöngyösi, M, Ekblond, A, Haack-Sørensen, M, Jaquet, K, Vrangbæk, K, Kastrup, J & SCIENCE Investigators 2019, 'Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE)', European Journal of Heart Failure, vol. 21, no. 8, pp. 1032-1041. https://doi.org/10.1002/ejhf.1412

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

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.",

author = "Christina Paitazoglou and Bergmann, {Martin W} and Bojan Vrtovec and Chamuleau, {Steven A J} and {van Klarenbosch}, Bas and Wojtek Wojakowski and Aleksandra Michalewska-W{\l}udarczyk and Mariann Gy{\"o}ngy{\"o}si and Annette Ekblond and Mandana Haack-S{\o}rensen and Kai Jaquet and Karsten Vrangb{\ae}k and Jens Kastrup and {SCIENCE Investigators}",

note = "{\textcopyright} 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.",

year = "2019",

month = aug,

doi = "10.1002/ejhf.1412",

language = "English",

volume = "21",

pages = "1032--1041",

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issn = "1388-9842",

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TY - JOUR

T1 - Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE)

AU - Paitazoglou, Christina

AU - Bergmann, Martin W

AU - Vrtovec, Bojan

AU - Chamuleau, Steven A J

AU - van Klarenbosch, Bas

AU - Wojakowski, Wojtek

AU - Michalewska-Włudarczyk, Aleksandra

AU - Gyöngyösi, Mariann

AU - Ekblond, Annette

AU - Haack-Sørensen, Mandana

AU - Jaquet, Kai

AU - Vrangbæk, Karsten

AU - Kastrup, Jens

AU - SCIENCE Investigators

PY - 2019/8

Y1 - 2019/8

N2 - 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.

AB - 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.

U2 - 10.1002/ejhf.1412

DO - 10.1002/ejhf.1412

M3 - Journal article

C2 - 30790396

SN - 1388-9842

VL - 21

SP - 1032

EP - 1041

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

IS - 8

ER -

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

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