Heart failure & cardiomyopathies
Effect of Allogeneic Adipose Tissue-Derived Mesenchymal Stromal Cell Treatment in Chronic Ischaemic Heart Failure with Reduced Ejection Fraction – the SCIENCE Trial
Authors' 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.
Study context
- Population
- Chronic ischaemic heart failure with reduced ejection fraction (HFrEF), New York Heart Association (NYHA) II–III, left ventricular ejection fraction (LVEF) <45%, NT-proBNP >300 pg/ml
- Participants
- 133 participants
- Comparison
- Allogeneic CSCC_ASCs vs placebo
- Primary endpoint
- Change in LV end-systolic volume (LVESV) by echocardiography
- Follow-up
- 6-month follow-up
Methodological detailsphase II, double-blind, placebo-controlled, multicentre, 2:1 randomization
- Phase II
- Double-blind
- Placebo-controlled
- Multicentre
- 2:1 randomization
Primary result
As reported in the abstract
Change in LVESV (echocardiography)
No significant difference between groups in left ventricular end-systolic volume (LVESV)
0.3 ± 5.0 ml, p = 0.945
Secondary outcomes
LV end-diastolic volume
- No significant difference between groups in LV end-diastolic volume
- −2.0 ± 6.0 ml, p = 0.736
LVEF
- No significant difference between groups in LVEF
- −1.6 ± 1.0%, p = 0.119
NYHA class · first year
- Slight improvement in both groups, no difference between groups
6-min walk test, NT-proBNP, C-reactive protein, quality of life · first year
- No changes in any group
Safety
Drug-related severe adverse events; cardiac-related adverse events · 3-year follow-up
- No drug-related severe adverse events
- No difference in cardiac-related adverse events
Original publication
Effect of Allogeneic Adipose Tissue-Derived Mesenchymal Stromal Cell Treatment in Chronic Ischaemic Heart Failure with Reduced Ejection Fraction – the SCIENCE Trial. Eur J Heart Fail. Published 31 January 2023. doi:10.
Summarised from the published abstract; every number is checked against it