Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement

Condition(s) studied

Study summary

Islet transplantation and pancreas transplantation are established therapeutic options for selected individuals with type 1 diabetes experiencing severe glycemic instability and recurrent hypoglycemia. Although these approaches significantly improve glycemic management and quality of life, long-term graft survival remains limited, with a progressive decline in beta-cell function over time.

The clinical benefit-risk profile of islet re-transplantation after graft failure remains poorly defined, and outcomes following repeat islet transplantation after prior islet graft failure have not been specifically evaluated.

Repeated exposure to multiple donors may increase the risk of alloimmunization, including the development of donor-specific antibodies , which may adversely affect graft survival and limit access to future transplantation.

This multicenter retrospective cohort study aims to evaluate the efficacy and safety of islet re-transplantation in adults with type 1 diabetes after failure of initial beta-cell replacement (islet or pancreas transplantation), with outcomes assessed at 3 months, 1 year, and 5 years.

Eligibility

Primary outcome measure(s)

• Islet graft success — Baseline, 3 months, 1 year, 5 years
  Assessed using Igls criteria (optimal or good graft function classification) based on C-peptide, insulin use, hemoglobin A1c, and severe hypoglycemia

Trial sites (1)

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