Effect of allogeneic adipose tissue‐derived mesenchymal stromal cell treatment in chronic ischaemic heart failure with reduced ejection fraction – the SCIENCE trial

Aims The 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 fractio...

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Published in:European journal of heart failure 2023-04, Vol.25 (4), p.576-587
Main Authors: Qayyum, Abbas Ali, 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
Format: Article
Language:English
Subjects:
Adipose tissue derived‐mesenchymal stromal cells
Allogeneic therapy
Chronic Disease
Clinical trial
Double-Blind Method
Heart Failure
Hematopoietic Stem Cell Transplantation
Humans
Ischaemic cardiomyopathy
Mesenchymal Stem Cells
Quality of Life
Stem cells
Stroke Volume
Treatment Outcome
Ventricular Function, Left
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Summary:Aims The 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 results The 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) 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. Conclusion The 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. Treatment of chronic ischaemic heart failure with reduced ejection fraction (HFrEF) patients with allogeneic adipose tissue‐derived stromal cells (ASC) was safe but without any demonstratable restoration of cardiac function or clinical symptoms. (A) Kaplan–Meier plot of freedom of cumulative combined cardiac‐related adverse events during a 3‐year follow‐up period. (B) Differences in baseline to 6‐month follow‐up in left ventricular end‐systolic volume (LVESV), left ventricular end‐diastolic volume (LVEDV) and left ventricular ejection fraction (LVEF) in ASC treated compared to placebo patients.
ISSN:1388-9842
1879-0844
DOI:10.1002/ejhf.2772