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

NCT07666789 | Recruiting

• 2 other identifiers: 2025-06-290A111/2025-06-290/001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes (T1D); Islets of Langerhans Transplantation

Keywords

islet transplantation; pancreas transplantation; type 1 diabetes; beta cell replacement; graft survival; glycemic control

Outcome Measures

Primary Outcomes (1)

• Islet graft success

  Assessed using Igls criteria (optimal or good graft function classification) based on C-peptide, insulin use, hemoglobin A1c, and severe hypoglycemia

  Baseline, 3 months, 1 year, 5 years

Secondary Outcomes (13)

• Glycemic Control_Glycated hemoglobin (HbA1c) level

  Baseline, 3 months, 1 year, 5 years

• Glycemic Control_Percentage of individuals with HbA1c < 7% and no severe hypoglycemia

  Baseline, 3 months, 12 months, 5 years

• Beta-Cell Function_BETA-2 score

  Baseline, 3 months, 1 year, 5 years

• Beta-Cell Function_BETA score

  Baseline, 3 months, 1 year, 5 years

• Beta-Cell Function_Severe hypoglycemia events

  Baseline, 3 months, 1 year, 5 years

Other Outcomes (10)

• Glycemic control_Time in range (70-180 mg/dL)

  Baseline, 3 months, 1 year and 5 years

• Glycemic control_Time in tight range (70-140 mg/dL)

  Baseline, 3 months, 1 year and 5 years

• Glycemic control_Time below range 70 mg/dL

  Baseline, 3 months, 1 year and 5 years

Study Arms (2)

Initial pancreas transplant

Islet after pancreas transplant failure

Initial islet transplant

Islet after islet transplant failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with type 1 diabetes who underwent prior beta-cell replacement therapy (pancreas or islet transplantation) and subsequent islet re-transplantation after graft failure.

You may qualify if:

• 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

You may not qualify if:

• Missing or incomplete data preventing assessment of the primary outcome

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University Hospital, Grenoble: collaborator
• University Hospital, Toulouse: collaborator
• University Hospital, Strasbourg: collaborator
• University Hospital, Lille: collaborator
• University Hospital, Paris: collaborator
• The Civil Hospitals, Lyon: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34000, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 37105208 BACKGROUND

• 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.

  PMID: 35864198 BACKGROUND

• 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.

  PMID: 30223084 BACKGROUND

• 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.

  PMID: 29528967 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Orianne OV Villard, MD

CONTACT

+33 467 338 382; orianne.villard@chu-montpellier.fr

Roxane RD Descaillot

CONTACT

roxanedescaillot@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 24, 2026
• Study Start: July 31, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

FR (1)