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 - on behalf of the SCIENCE Investigators
AU - Ciosek, Joanna
AU - Dworowy, Sebastian
AU - Jadczyk, Tomasz
AU - Kozłowski, Michal
AU - Nadrowski, Pawel
AU - Sagalski, Ronja
AU - Schlegel, Esther
AU - Schmidt, Annette
AU - Sikora, Anna
AU - Skiba, Dorota
AU - Traxler, Denise
AU - Qayyum, Abbas Ali
AU - Mathiasen, Anders B.
PY - 2019/1/1
Y1 - 2019/1/1
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.
UR - http://www.scopus.com/inward/record.url?scp=85069632379&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ejhf.1412
DO - https://doi.org/10.1002/ejhf.1412
M3 - 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 -