A multi-centre study of belatacept and sirolimus for islet transplantation
Authors' conclusion
Baseline immunosuppression with bela/siro facilitated early islet engraftment and rates of insulin independence, with less impact on renal function, supporting the rationale for routine use in islet transplantation.
Study context
- Population
- Participants with T1D receiving at least one islet transplant
- Participants
- 9 vs 24
- Comparison
- Belatacept/sirolimus vs tacrolimus/mycophenolate mofetil
- Bela/siron = 9
- tac/MMFn = 24reference
- Primary endpoint
- Freedom from hypoglycaemia, with positive C-peptide and HbA1c <53 mmol/mol (7.0%)
- Follow-up
- 12 months after the first transplant
Methodological detailsphase 2, multi-centre, open-label, contemporaneous comparison cohort
- Phase 2
- Multi-centre
- Open-label
- Contemporaneous comparison cohort
Primary result
As reported in the abstract
Freedom from hypoglycaemia, positive C-peptide and HbA1c <53 mmol/mol (7.0%) · 12 months
Secondary outcomes
HbA1c, HYPO score and insulin requirements
- Reduced in both groups
Renal function
- Remained unchanged only in the bela/siro group
Peripheral blood immune cell populations
- Sustained suppression of all monocyte, NK, T and B cell subsets
- CD4+FOXP3+ regulatory T cell proportions higher in the bela/siro group
Original publication
A multi-centre study of belatacept and sirolimus for islet transplantation. Diabetologia. Published 17 August 2026. doi:10.
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