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

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Standard

Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE). / Paitazoglou, Christina; Bergmann, Martin W; Vrtovec, Bojan; Chamuleau, Steven A J; van Klarenbosch, Bas; Wojakowski, Wojtek; Michalewska-Włudarczyk, Aleksandra; Gyöngyösi, Mariann; Ekblond, Annette; Haack-Sørensen, Mandana; Jaquet, Kai; Vrangbæk, Karsten; Kastrup, Jens; SCIENCE Investigators.

I: European Journal of Heart Failure, Bind 21, Nr. 8, 2019, s. 1032-1041.

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Harvard

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, bind 21, nr. 8, s. 1032-1041. https://doi.org/10.1002/ejhf.1412

APA

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

Vancouver

Paitazoglou C, Bergmann MW, Vrtovec B, Chamuleau SAJ, van Klarenbosch B, Wojakowski W o.a. Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE). European Journal of Heart Failure. 2019;21(8):1032-1041. https://doi.org/10.1002/ejhf.1412

Author

Paitazoglou, Christina ; Bergmann, Martin W ; Vrtovec, Bojan ; Chamuleau, Steven A J ; van Klarenbosch, Bas ; Wojakowski, Wojtek ; Michalewska-Włudarczyk, Aleksandra ; Gyöngyösi, Mariann ; Ekblond, Annette ; Haack-Sørensen, Mandana ; Jaquet, Kai ; Vrangbæk, Karsten ; Kastrup, Jens ; SCIENCE Investigators. / Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE). I: European Journal of Heart Failure. 2019 ; Bind 21, Nr. 8. s. 1032-1041.

Bibtex

@article{b918b205b17e4b2499e63daf23aff6d8,
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",
doi = "10.1002/ejhf.1412",
language = "English",
volume = "21",
pages = "1032--1041",
journal = "European Journal of Heart Failure",
issn = "1567-4215",
publisher = "JohnWiley & Sons Ltd",
number = "8",

}

RIS

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

N1 - © 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

PY - 2019

Y1 - 2019

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

VL - 21

SP - 1032

EP - 1041

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

SN - 1567-4215

IS - 8

ER -

ID: 222621348