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Type 1 Diabetes (T1D)MULT-ILOTNCT07666789

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

An observational study of Type 1 Diabetes (T1D) and Islets of Langerhans Transplantation, run by University Hospital, Montpellier at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Islet transplantation and pancreas transplantation are established therapeutic options for selected individuals with type 1 diabetes experiencing severe glycemic instability and recurrent hypoglycemia. Read more about this study

Who is it for?
Ages 18 years and older
How many people
20 participants
Where
1 siteFrance
Study dates
31 Jul 2025to 30 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Missing or incomplete data preventing assessment of the primary outcome
  • Patients who did not meet inclusion criteria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Orianne OV Villard, MD contact

+33 467 338 382

orianne.villard@chu-montpellier.fr

Roxane RD Descaillot contact

roxanedescaillot@gmail.com

France1 site, 1 recruiting

  • Montpellier University Hospital

    Montpellier, 34000

    Orianne OV Villard, MD, +33 467 338 382, orianne.villard@chu-montpellier.fr

    Orianne OV Villard, MD

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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.

Keywords
islet transplantation, pancreas transplantation, type 1 diabetes, beta cell replacement, graft survival, glycemic control
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07666789
Study groupRoleWhat they receive
Initial pancreas transplantIslet after pancreas transplant failure
Initial islet transplantIslet after islet transplant failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 3 months, 1 year, 5 years

Secondary outcomes (13)

  1. Glycemic Control_Glycated hemoglobin (HbA1c) level

    HbA1c level, measured by HPLC method

    Measured: Baseline, 3 months, 1 year, 5 years

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

    Measured: Baseline, 3 months, 12 months, 5 years

  3. Beta-Cell Function_BETA-2 score

    Derived from fasting glucose, paired fasting C-peptide, insulin dose and Hba1c and generates a single value between 0 and 42

    Measured: Baseline, 3 months, 1 year, 5 years

  4. Beta-Cell Function_BETA score

    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

    Measured: Baseline, 3 months, 1 year, 5 years

  5. Beta-Cell Function_Severe hypoglycemia events

    Percentage of individual with severe hypoglycemia events

    Measured: Baseline, 3 months, 1 year, 5 years

  6. Beta-Cell Function_Residual beta cell function

    Percentage of individual with fasting plasma C-peptide > 0.3 ng/mL

    Measured: Baseline, 3 months, 1 year, 5 years

  7. Immunological Outcomes_Donor-specific antibodies (DSA)

    Presence and specificity of donor-specific antibodies (DSA) with classification :

    • Preformed and de novo
    • Class I and II specificity
    • and Mean fluorescence intensity (MFI)

    Measured: Baseline, 3 months, 1 year, 5 years

  8. Immunological Outcomes_Autoantibodies

    Dosage of antibodies anti-GAD, anti-IA2, anti-insulin, and anti-ZnT8

    Measured: Baseline, 3 months, 1 year, 5 years

  9. Safety of islet re-transplantation_Procedural complications of islet infusions

    Reported of procedural complications of islet infusions such as portal thrombosis, hematoma, transfusion requirement

    Measured: Baseline, 3 months, 1 year, 5 years

  10. Safety of islet re-transplantation_Renal function eGFR

    Estimated GFR from serum creatinine level

    Measured: Baseline, 3 months, 1 year, 5 years

  11. Safety of islet re-transplantation_Albuminuria

    Measurement of albuminuria or proteinuria

    Measured: Baseline, 3 months, 1 year, 5 years

  12. Safety of islet re-transplantation_Immunosuppression-related complications

    Reported immunosuppression-related complications such as infections ; malignancy, cardiovascular events

    Measured: 3 months, 1 year, 5 years

  13. Safety of islet re-transplantation_Mortality

    Patient death

    Measured: 3 months, 1 year, 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start31 Jul 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07666789
Sponsor's protocol ID
2025-06-290
Other IDs
A111/2025-06-290/001
Acronym
MULT-ILOT
Status last verified
Jun 2026
First submitted
9 Jun 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37105208

  • 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.

    PubMed 35864198

  • 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.

    PubMed 30223084

  • 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.

    PubMed 29528967

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes (T1D) and Islets of Langerhans Transplantation, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Orianne OV Villard, MD (+33 467 338 382, orianne.villard@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Islet graft success (time frame: Baseline, 3 months, 1 year, 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07666789, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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