Heart failure & cardiomyopathies
Danish Phase II Trial Using Adipose Tissue Derived Mesenchymal Stromal Cells for Patients with Ischaemic Heart Failure
Primary result · LVESV, baseline to 6 monthsResult — go to the resultDifference 0.0 mL 95% CI −9.1 to 9.0Authors' conclusion
Intramyocardial CSCC_ASC injections in patients with chronic HFrEF were safe but did not improve myocardial function or structure, nor clinical symptoms.
Study context
- Population
- Chronic ischaemic HFrEF (LVEF ≤ 45%, New York Heart Association (NYHA) II–III) despite optimal HF medication, no further revascularisation options
- Participants
- 81 participants
- Comparison
- Intramyocardial allogeneic CSCC_ASC vs placebo
- ASCn = 54
- Placebon = 27reference
- Primary endpoint
- LV end systolic volume (left ventricular end systolic volume (LVESV))
- Follow-up
- 6-month follow-up
Methodological detailsmulticentre, double-blind, placebo-controlled, phase II, 2:1 randomisation, Safety measured during a 3-years follow-up period
- Multicentre
- Double-blind
- Placebo-controlled
- Phase II
- 2:1 randomisation
- Safety measured during a 3-years follow-up period
Primary result
LVESV, baseline to 6 months
Difference
0.0 mL
95% CI −9.1 to 9.0
P = 0.992
By group
ASC
- Baseline
- 125.7 ± 68.8 mL
- 6 months
- 126.3 ± 72.5 mL
- Within-group P
- P = 0.827
Placebo
- Baseline
- 134.6 ± 45.8 mL
- 6 months
- 135.3 ± 49.6 mL
- Within-group P
- P = 0.855
Baseline
ASC125.7 ± 68.8 mL
Placebo134.6 ± 45.8 mL
6 months
ASC126.3 ± 72.5 mL
Placebo135.3 ± 49.6 mL
Within-group P
ASCP = 0.827
PlaceboP = 0.855
ASC vs Placebo
difference 0.0 mL (95% CI −9.1 to 9.0); P = 0.992
As reported in the abstract
Further findings
| Outcome | Difference (mL) (95% CI) | P value | |
|---|---|---|---|
| LV end diastolic volume · 6-month follow-up | −5.7 (−16.7 to 5.3) | P = 0.306 | |
| −20−10010Difference, mL (linear scale) |
| Outcome | Difference (%) (95% CI) | P value | |
|---|---|---|---|
| LVEF · 6-month follow-up | −1.7 (−4.4. to 1.0) | P = 0.212 | |
| −6−4−202Difference, % (linear scale) |
LV end diastolic volume · 6-month follow-up
- No significant changes within the two groups
LVEF · 6-month follow-up
- No significant changes within the two groups
NYHA class and 6-min walk test
- Did not alter significantly in the two groups
- P > 0.05
Quality of life, total symptom and overall summary score
- Improved significantly only in the ASC group but not between groups
Safety
Combined cardiac events, mean time to event (Kaplan-Meier, log-rank) · 3 years follow-up
P = 0.994
Events
| Outcome | ASC | Placebo |
|---|---|---|
| Serious adverse events · 1-year follow-up | 24 | 11 |
Serious adverse events · 1-year follow-up
- No significant difference between the groups
Original publication
Danish Phase II Trial Using Adipose Tissue Derived Mesenchymal Stromal Cells for Patients with Ischaemic Heart Failure. ESC Heart Fail. Published 13 January 2023. doi:10.
Summarised from the published abstract; every number is checked against it