Long-term outcomes of pancreatic islet transplantation alone in type 1 diabetes: a 20-year single-centre study in Italy
Authors' conclusion
This analysis of a large islet transplantation alone cohort provides valuable insights into factors influencing outcomes and highlights potential risks, supporting informed clinical decision making and the optimisation of future β-cell replacement strategies.
Study context
- Population
- Adults aged 18–67 years with T1D diagnosed before age 55 years with severe recurrent hypoglycaemia or glycaemic instability, receiving intraportal islet transplantation alone at IRCCS Ospedale San Raffaele, Milan, Italy (2001–2023)159 islet infusions
- Participants
- 79 adults
- Outcome
- Graft survival (fasting C peptide ≥0.3 ng/mL) and insulin independence
Methodological detailssingle-centre, intention-to-treat analysis
- Single-centre
- Intention-to-treat analysis
Main finding
As reported in the abstract
Median graft survival
3.9 years
95% CI 1.6 to 6.2
Insulin independence
44%
35/79
Median duration of insulin independence
6 years
95% CI 2.88 to 9.08
Kaplan-Meier graft survival at 1, 5, 10, 15, 20 years
86%, 65%, 47%, 47%, 40%
Observational data: associations, not effects.
Further findings
Glycaemic control after infusion
- HbA1c reduction
- −10.04 mmol/mol (−13.63 to −6.46)
- Daily insulin requirement decrease
- −13.35 units per day (−17.04 to −9.65)
Subgroup >10 000 islet equivalents (IEQ)/kg with BAS, FK506 and Rapa
- Median graft survival
- 9.7 years (3.1-16.0)
- Insulin independence
- 73% (16 of 22)
Patient survival · median follow-up 13.1 years
- Overall survival
- 92% (73 of 79)
- 20-year survival probability
- 84%
Safety
Procedural complications
- Complications infrequent, mostly minor bleeding; surgical intervention required
- 3% (two of 79)
Immunosuppression-related adverse events and allosensitisation
- Adverse events related to immunosuppressive therapy
- 44% (35 of 79)
- Allosensitisation: baseline vs after therapy discontinuation
- 6% vs 42%
Original publication
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