Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement (MULT-ILOT)
21 juni 2026 bijgewerkt door: University Hospital, Montpellier
Efficacy and Safety of Islet Re-transplantation After Failure of Beta-cell Replacement
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.
Studie Overzicht
Toestand
Werving
Studietype
Observationeel
Inschrijving (Geschat)
20
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Orianne OV Villard, MD
- Telefoonnummer: +33 467 338 382
- E-mail: orianne.villard@chu-montpellier.fr
Studie Contact Back-up
- Naam: Roxane RD Descaillot
- E-mail: roxanedescaillot@gmail.com
Studie Locaties
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-
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Montpellier, Frankrijk, 34000
- Werving
- Montpellier University Hospital
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Contact:
- Orianne OV Villard, MD
- Telefoonnummer: +33 467 338 382
- E-mail: orianne.villard@chu-montpellier.fr
-
Hoofdonderzoeker:
- Orianne OV Villard, MD
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Adults with type 1 diabetes who underwent prior beta-cell replacement therapy (pancreas or islet transplantation) and subsequent islet re-transplantation after graft failure.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
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Initial pancreas transplant
Islet after pancreas transplant failure
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Initial islet transplant
Islet after islet transplant failure
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Islet graft success
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
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Assessed using Igls criteria (optimal or good graft function classification) based on C-peptide, insulin use, hemoglobin A1c, and severe hypoglycemia
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Baseline, 3 months, 1 year, 5 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Glycemic Control_Glycated hemoglobin (HbA1c) level
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
|
HbA1c level, measured by HPLC method
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Baseline, 3 months, 1 year, 5 years
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Glycemic Control_Percentage of individuals with HbA1c < 7% and no severe hypoglycemia
Tijdsspanne: Baseline, 3 months, 12 months, 5 years
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Baseline, 3 months, 12 months, 5 years
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|
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Beta-Cell Function_BETA-2 score
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
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Derived from fasting glucose, paired fasting C-peptide, insulin dose and Hba1c and generates a single value between 0 and 42
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Baseline, 3 months, 1 year, 5 years
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Beta-Cell Function_BETA score
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
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Derived from fasting glucose, HbA1c, stimulated C-peptide, and absence of insulin or oral hypoglycemic agent use and generates a single value between 0 and 8
|
Baseline, 3 months, 1 year, 5 years
|
|
Beta-Cell Function_Severe hypoglycemia events
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
|
Percentage of individual with severe hypoglycemia events
|
Baseline, 3 months, 1 year, 5 years
|
|
Beta-Cell Function_Residual beta cell function
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
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Percentage of individual with fasting plasma C-peptide > 0.3 ng/mL
|
Baseline, 3 months, 1 year, 5 years
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|
Immunological Outcomes_Donor-specific antibodies (DSA)
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
|
Presence and specificity of donor-specific antibodies (DSA) with classification :
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Baseline, 3 months, 1 year, 5 years
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Immunological Outcomes_Autoantibodies
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
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Dosage of antibodies anti-GAD, anti-IA2, anti-insulin, and anti-ZnT8
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Baseline, 3 months, 1 year, 5 years
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Safety of islet re-transplantation_Procedural complications of islet infusions
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
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Reported of procedural complications of islet infusions such as portal thrombosis, hematoma, transfusion requirement
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Baseline, 3 months, 1 year, 5 years
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Safety of islet re-transplantation_Renal function eGFR
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
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Estimated GFR from serum creatinine level
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Baseline, 3 months, 1 year, 5 years
|
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Safety of islet re-transplantation_Albuminuria
Tijdsspanne: Baseline, 3 months, 1 year, 5 years
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Measurement of albuminuria or proteinuria
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Baseline, 3 months, 1 year, 5 years
|
|
Safety of islet re-transplantation_Immunosuppression-related complications
Tijdsspanne: 3 months, 1 year, 5 years
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Reported immunosuppression-related complications such as infections ; malignancy, cardiovascular events
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3 months, 1 year, 5 years
|
|
Safety of islet re-transplantation_Mortality
Tijdsspanne: 3 months, 1 year, 5 years
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Patient death
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3 months, 1 year, 5 years
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Glycemic control_Time in range (70-180 mg/dL)
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 180 mg/dL
|
Baseline, 3 months, 1 year and 5 years
|
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Glycemic control_Time in tight range (70-140 mg/dL)
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 140 mg/dL
|
Baseline, 3 months, 1 year and 5 years
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Glycemic control_Time below range 70 mg/dL
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 54 mg/dL
|
Baseline, 3 months, 1 year and 5 years
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Glycemic control_Time below range 54 mg/dL
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose below 54 mg/dL
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Time above range 180 mg/dL
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose between 180 and 250 mg/dL
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Time above range 250 mg/dL
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose above 250 mg/dL
|
Baseline, 3 months, 1 year and 5 years
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Glycemic control_Mean glucose
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) derived-metrics
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Coefficient of variation
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) derived-metrics
|
Baseline, 3 months, 1 year and 5 years
|
|
Glycemic control_Glycemic risk index
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) derived-metrics
|
Baseline, 3 months, 1 year and 5 years
|
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Glycemic control_Glucose Management Indicator (GMI)
Tijdsspanne: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) derived-metrics
|
Baseline, 3 months, 1 year and 5 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Chetboun M, Drumez E, Ballou C, Maanaoui M, Payne E, Barton F, Kerr-Conte J, Vantyghem MC, Piemonti L, Rickels MR, Labreuche J, Pattou F; Collaborative Islet Transplant Registry (CITR) Investigators study group. Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry. Lancet Diabetes Endocrinol. 2023 Jun;11(6):391-401. doi: 10.1016/S2213-8587(23)00082-7. Epub 2023 Apr 24.
- Maanaoui M, Chetboun M, Top I, Elsermans V, Kerr-Conte J, Le Mapihan K, Defrance F, Gmyr V, Hubert T, Labalette M, Hazzan M, Vantyghem MC, Pattou F. The challenge of HLA donor specific antibodies in the management of pancreatic islet transplantation: an illustrative case-series. Sci Rep. 2022 Jul 21;12(1):12463. doi: 10.1038/s41598-022-16782-3.
- Wojtusciszyn A, Branchereau J, Esposito L, Badet L, Buron F, Chetboun M, Kessler L, Morelon E, Berney T, Pattou F, Benhamou PY, Vantyghem MC; TREPID group. Indications for islet or pancreatic transplantation: Statement of the TREPID working group on behalf of the Societe francophone du diabete (SFD), Societe francaise d'endocrinologie (SFE), Societe francophone de transplantation (SFT) and Societe francaise de nephrologie - dialyse - transplantation (SFNDT). Diabetes Metab. 2019 Jun;45(3):224-237. doi: 10.1016/j.diabet.2018.07.006. Epub 2018 Sep 14.
- Rickels MR, Stock PG, de Koning EJP, Piemonti L, Pratschke J, Alejandro R, Bellin MD, Berney T, Choudhary P, Johnson PR, Kandaswamy R, Kay TWH, Keymeulen B, Kudva YC, Latres E, Langer RM, Lehmann R, Ludwig B, Markmann JF, Marinac M, Odorico JS, Pattou F, Senior PA, Shaw JAM, Vantyghem MC, White S. Defining Outcomes for beta-cell Replacement Therapy in the Treatment of Diabetes: A Consensus Report on the Igls Criteria From the IPITA/EPITA Opinion Leaders Workshop. Transplantation. 2018 Sep;102(9):1479-1486. doi: 10.1097/TP.0000000000002158.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 juli 2025
Primaire voltooiing (Geschat)
30 september 2026
Studie voltooiing (Geschat)
30 september 2026
Studieregistratiedata
Eerst ingediend
9 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
21 juni 2026
Eerst geplaatst (Werkelijk)
24 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
21 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025-06-290
- A111/2025-06-290/001 (Andere identificatie: Scientific and ethics committee of the Montpellier University Hospital)
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