Effect of allogeneic adipose tissue derived mesenchymal stromal cell treatment in chronic ischemic heart failure with reduced ejection fraction – The SCIENCE Trial
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Effect of allogeneic adipose tissue derived mesenchymal stromal cell treatment in chronic ischemic heart failure with reduced ejection fraction – The SCIENCE Trial. / Qayyum, Abbas Ali; Van Klarenbosch, Bas; Frljak, Sabina; Cerar, Andraz; Poglajen, Gregor; Traxler‐weidenauer, Denise; Nadrowski, Pawel; Paitazoglou, Christina; Vrtovec, Bojan; Bergmann, Martin W.; Chamuleau, Steven A.j.; Wojakowski, Wojtek; Gyöngyösi, Mariann; Kraaijeveld, Adriaan; Hansen, Kristian Schultz; Vrangbæk, Karsten; Jørgensen, Erik; Helqvist, Steffen; Joshi, Francis Richard; Johansen, Ellen Mønsted; Follin, Bjarke; Juhl, Morten; Højgaard, Lisbeth Drozd; Mathiasen, Anders Bruun; Ekblond, Annette; Haack‐sørensen, Mandana; Kastrup, Jens.
In: European Journal of Heart Failure, Vol. 25, No. 4, 2023, p. 576-587.Research output: Contribution to journal › Journal article › Research › peer-review
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T1 - Effect of allogeneic adipose tissue derived mesenchymal stromal cell treatment in chronic ischemic heart failure with reduced ejection fraction – The SCIENCE Trial
AU - Qayyum, Abbas Ali
AU - Van Klarenbosch, Bas
AU - Frljak, Sabina
AU - Cerar, Andraz
AU - Poglajen, Gregor
AU - Traxler‐weidenauer, Denise
AU - Nadrowski, Pawel
AU - Paitazoglou, Christina
AU - Vrtovec, Bojan
AU - Bergmann, Martin W.
AU - Chamuleau, Steven A.j.
AU - Wojakowski, Wojtek
AU - Gyöngyösi, Mariann
AU - Kraaijeveld, Adriaan
AU - Hansen, Kristian Schultz
AU - Vrangbæk, Karsten
AU - Jørgensen, Erik
AU - Helqvist, Steffen
AU - Joshi, Francis Richard
AU - Johansen, Ellen Mønsted
AU - Follin, Bjarke
AU - Juhl, Morten
AU - Højgaard, Lisbeth Drozd
AU - Mathiasen, Anders Bruun
AU - Ekblond, Annette
AU - Haack‐sørensen, Mandana
AU - Kastrup, Jens
PY - 2023
Y1 - 2023
N2 - AimsThe aim of the SCIENCE trial was to investigate whether a single treatment with direct intramyocardial injections of adipose tissue-derived mesenchymal stromal cells (CSCC_ASCs) was safe and improved cardiac function in patients with chronic ischaemic heart failure with reduced ejection fraction (HFrEF).Methods and resultsThe study was a European multicentre, double-blind, placebo-controlled phase II trial using allogeneic CSCC_ASCs from healthy donors or placebo (2:1 randomization). Main inclusion criteria were New York Heart Association (NYHA) class II–III, left ventricular ejection fraction (LVEF) <45%, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels >300 pg/ml. CSCC_ASCs or placebo (isotonic saline) were injected directly into viable myocardium. The primary endpoint was change in left ventricular end-systolic volume (LVESV) at 6-month follow-up measured by echocardiography. A total of 133 symptomatic HFrEF patients were included. The treatment was safe without any drug-related severe adverse events or difference in cardiac-related adverse events during a 3-year follow-up period. There were no significant differences between groups during follow-up in LVESV (0.3 ± 5.0 ml, p = 0.945), nor in secondary endpoints of left ventricular end-diastolic volume (−2.0 ± 6.0 ml, p = 0.736) and LVEF (−1.6 ± 1.0%, p = 0.119). The NYHA class improved slightly within the first year in both groups without any difference between groups. There were no changes in 6-min walk test, NT-proBNP, C-reactive protein or quality of life the first year in any groups.ConclusionThe SCIENCE trial demonstrated safety of intramyocardial allogeneic CSCC_ASC therapy in patients with chronic HFrEF. However, it was not possible to improve the pre-defined endpoints and induce restoration of cardiac function or clinical symptoms.
AB - AimsThe aim of the SCIENCE trial was to investigate whether a single treatment with direct intramyocardial injections of adipose tissue-derived mesenchymal stromal cells (CSCC_ASCs) was safe and improved cardiac function in patients with chronic ischaemic heart failure with reduced ejection fraction (HFrEF).Methods and resultsThe study was a European multicentre, double-blind, placebo-controlled phase II trial using allogeneic CSCC_ASCs from healthy donors or placebo (2:1 randomization). Main inclusion criteria were New York Heart Association (NYHA) class II–III, left ventricular ejection fraction (LVEF) <45%, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels >300 pg/ml. CSCC_ASCs or placebo (isotonic saline) were injected directly into viable myocardium. The primary endpoint was change in left ventricular end-systolic volume (LVESV) at 6-month follow-up measured by echocardiography. A total of 133 symptomatic HFrEF patients were included. The treatment was safe without any drug-related severe adverse events or difference in cardiac-related adverse events during a 3-year follow-up period. There were no significant differences between groups during follow-up in LVESV (0.3 ± 5.0 ml, p = 0.945), nor in secondary endpoints of left ventricular end-diastolic volume (−2.0 ± 6.0 ml, p = 0.736) and LVEF (−1.6 ± 1.0%, p = 0.119). The NYHA class improved slightly within the first year in both groups without any difference between groups. There were no changes in 6-min walk test, NT-proBNP, C-reactive protein or quality of life the first year in any groups.ConclusionThe SCIENCE trial demonstrated safety of intramyocardial allogeneic CSCC_ASC therapy in patients with chronic HFrEF. However, it was not possible to improve the pre-defined endpoints and induce restoration of cardiac function or clinical symptoms.
U2 - 10.1002/ejhf.2772
DO - 10.1002/ejhf.2772
M3 - Journal article
C2 - 36644821
VL - 25
SP - 576
EP - 587
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
SN - 1567-4215
IS - 4
ER -
ID: 332609957