Heart failure & cardiomyopathiesRandomised controlled trial
Intramyocardial injection of allogeneic human induced pluripotent stem cell-derived cardiomyocytes in advanced ischemic heart failure: an early-stage randomized trial
- Randomised controlled trial
- early-stage
Study context
- Population
- Advanced HFrEF (LVEF ≤45%) undergoing CABG18 male, 2 female
- Participants
- 20 participants
- Comparison
- Intramyocardial hiPSC-derived cardiomyocytes + CABG vs CABG alone
- Cell therapyn = 10
- Primary endpoint
- Safety: sustained VT during 1–6 months postoperatively and tumorigenicity at 12 months
- Follow-up
- 1- to 6-month postoperative period; 12 months
Primary result
As reported in the abstract
Sustained VT and tumorigenicity
- Neither sustained VT nor tumorigenicity observed in either group
Secondary outcomes
6-min walk distance, global myocardial perfusion (summed rest score, 99mTc SPECT-CT), relative wall thickening
- Significantly greater improvements with cell transplantation vs CABG alone
LVEF, LV volumes, myocardial scar size, NYHA class, Minnesota Living with Heart Failure Questionnaire · 12 months
- No significant between-group differences
Safety
| Outcome | Cell therapy | Coronary artery bypass grafting alone |
|---|---|---|
| Accelerated idioventricular rhythm (first 4 weeks) · typically 5 to 7 days post-transplantation | 10 events | Not reported in the abstract |
- Accelerated idioventricular rhythm (first 4 weeks): all 10 patients in the cell therapy group
Clinically significant VT (>140 bpm) · peaked at 2 to 3 weeks post-procedure
- Occurred in 2 patients; resolved completely after cardioversion
Original publication
Intramyocardial injection of allogeneic human induced pluripotent stem cell-derived cardiomyocytes in advanced ischemic heart failure: an early-stage randomized trial. Nat Med. Published 19 August 2026. doi:10.1038/s41591-026-04605-1
Summarised from the published abstract; every number is checked against it