NCT07666789 Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement
| NCT ID | NCT07666789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-07-31 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of type 1 diabetes * Prior beta-cell replacement therapy : islet transplantation or pancreas transplantation * Islet re-transplantation performed after 2005 * Islet re-transplantation performed after documented beta cell graft failure, defined by undetectable C-peptide and/or recurrence of severe hypoglycemia on insulin therapy * Availability of clinical and biological data required for assessment of study outcomes Exclusion Criteria: * Missing or incomplete data preventing assessment of the primary outcome * Patients who did not meet inclusion criteria
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07666789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07666789 currently recruiting?
Yes, NCT07666789 is actively recruiting participants. Contact the research team at orianne.villard@chu-montpellier.fr for enrollment information.
Where is the NCT07666789 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT07666789 clinical trial?
NCT07666789 is sponsored by University Hospital, Montpellier. The trial plans to enroll 20 participants.
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