Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement (MULT-ILOT)
21. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
20
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Orianne OV Villard, MD
- Telefonnummer: +33 467 338 382
- E-Mail: orianne.villard@chu-montpellier.fr
Studieren Sie die Kontaktsicherung
- Name: Roxane RD Descaillot
- E-Mail: roxanedescaillot@gmail.com
Studienorte
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Montpellier, Frankreich, 34000
- Rekrutierung
- Montpellier University Hospital
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Kontakt:
- Orianne OV Villard, MD
- Telefonnummer: +33 467 338 382
- E-Mail: orianne.villard@chu-montpellier.fr
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Hauptermittler:
- Orianne OV Villard, MD
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Adults with type 1 diabetes who underwent prior beta-cell replacement therapy (pancreas or islet transplantation) and subsequent islet re-transplantation after graft failure.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Islet graft success
Zeitfenster: 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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Glycemic Control_Glycated hemoglobin (HbA1c) level
Zeitfenster: Baseline, 3 months, 1 year, 5 years
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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
Zeitfenster: Baseline, 3 months, 12 months, 5 years
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Baseline, 3 months, 12 months, 5 years
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Beta-Cell Function_BETA-2 score
Zeitfenster: 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
Zeitfenster: 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
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Baseline, 3 months, 1 year, 5 years
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Beta-Cell Function_Severe hypoglycemia events
Zeitfenster: Baseline, 3 months, 1 year, 5 years
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Percentage of individual with severe hypoglycemia events
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Baseline, 3 months, 1 year, 5 years
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Beta-Cell Function_Residual beta cell function
Zeitfenster: Baseline, 3 months, 1 year, 5 years
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Percentage of individual with fasting plasma C-peptide > 0.3 ng/mL
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Baseline, 3 months, 1 year, 5 years
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Immunological Outcomes_Donor-specific antibodies (DSA)
Zeitfenster: Baseline, 3 months, 1 year, 5 years
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
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Safety of islet re-transplantation_Immunosuppression-related complications
Zeitfenster: 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
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Safety of islet re-transplantation_Mortality
Zeitfenster: 3 months, 1 year, 5 years
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Patient death
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3 months, 1 year, 5 years
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Glycemic control_Time in range (70-180 mg/dL)
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 180 mg/dL
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Time in tight range (70-140 mg/dL)
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 140 mg/dL
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Time below range 70 mg/dL
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 54 mg/dL
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Time below range 54 mg/dL
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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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
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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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
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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Continuous Glucose Monitoring (CGM) measured time with glucose above 250 mg/dL
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Mean glucose
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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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
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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Continuous Glucose Monitoring (CGM) derived-metrics
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Glycemic risk index
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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Continuous Glucose Monitoring (CGM) derived-metrics
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Baseline, 3 months, 1 year and 5 years
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Glycemic control_Glucose Management Indicator (GMI)
Zeitfenster: Baseline, 3 months, 1 year and 5 years
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Continuous Glucose Monitoring (CGM) derived-metrics
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Baseline, 3 months, 1 year and 5 years
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn (Tatsächlich)
31. Juli 2025
Primärer Abschluss (Geschätzt)
30. September 2026
Studienabschluss (Geschätzt)
30. September 2026
Studienanmeldedaten
Zuerst eingereicht
9. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. Juni 2026
Zuerst gepostet (Tatsächlich)
24. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025-06-290
- A111/2025-06-290/001 (Andere Kennung: Scientific and ethics committee of the Montpellier University Hospital)
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