Heart failure & cardiomyopathies
Mesenchymal Stromal Cells to Treat Patients with Non-Ischaemic Heart Failure: Results from SCIENCE II Pilot Study
Authors' conclusion
Intramyocardial injections of allogeneic CSCC_ASC in patients with chronic non-ischaemic HFrEF was safe and improved LVESV, LVEF, NYHA class, and self-reported health compared with standard care group.
Study context
- Population
- Chronic non-ischaemic HFrEF (left ventricular ejection fraction (LVEF) <40%), New York Heart Association (NYHA) class ≥II despite optimal HF medication, NT-proBNP >300 pg/mL
- Participants
- 30 participants
- Comparison
- Intramyocardial allogeneic adipose-derived MSCs vs standard care
- Primary endpoint
- LVESV
- Follow-up
- 6 months
Methodological detailssingle-centre, investigator-initiated, phase I/II, 2:1 randomisation, blinded echo assessment
- Single-centre
- Investigator-initiated
- Phase I/II
- 2:1 randomisation
- Blinded echo assessment
Primary result
As reported in the abstract
baseline to 6 months follow-up
| Group | Baseline | 6 months | Within-group change |
|---|---|---|---|
| ASC | 153.7 ± 53.2 mL | 128.7 ± 45.6 mL | P < 0.001 |
| Standard care | 180.4 ± 39.4 mL | 186.7 ± 48.9 mL | P = 0.652 |
Baseline
ASC153.7 ± 53.2 mL
Standard care180.4 ± 39.4 mL
6 months
ASC128.7 ± 45.6 mL
Standard care186.7 ± 48.9 mL
Within-group change
ASCP < 0.001
Standard careP = 0.652
- Significant between-group difference in left ventricular end systolic volume (LVESV) change
- 31.3 ± 11.0 mL, P = 0.009
Further findings
Left ventricular end diastolic volume (LVEDV) change, between groups · baseline to follow-up
- Difference between the two groups in LVEDV
- 18.7 ± 12.4 mL, P = 0.146
LVEF change, between groups · baseline to follow-up
- Difference between the two groups in LVEF
- −7.8 ± 2.1%, P = 0.001
LVESV, LVEDV, LVEF change adjusted for baseline values · baseline to follow-up
- LVESV, baseline-adjusted
- P-value of 0.056
- LVEDV, baseline-adjusted
- 0.076
- LVEF, baseline-adjusted
- 0.738
NYHA class and self-reported health
- NYHA class improved significantly in ASC vs standard care
- 0.7 ± 0.2, P = 0.001
- Self-reported health improved significantly in ASC vs standard care
- −12.8 ± 5.3, P = 0.025
NT-proBNP
- No difference in NT-proBNP between groups
- −371 ± 455 pmol/L, P = 0.422
6-min walk test
- No difference in 6 min walk test between groups
- 12 ± 31 m, P = 0.695
Safety
- No difference in serious adverse events between groups
Original publication
Mesenchymal Stromal Cells to Treat Patients with Non-Ischaemic Heart Failure: Results from SCIENCE II Pilot Study. ESC Heart Fail. Published 22 July 2024. doi:10.
Summarised from the published abstract; every number is checked against it