Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation

January 8, 2018 updated by: University Hospital, Lille

Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression

This single center phase 2 clinical trial, is designed for confirming the efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with previous kidney transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus have been recognized.

The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.

The study primary efficacy endpoint is graft survival defined as insulin independence and HbA1c < 8% at 1 year post first transplant. Secondary outcomes are graft function and metabolic control

The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord
      • Lille, Nord, France, 59000
        • University Hospital of Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide and diagnosis of diabetes for at least 5 years.
  • Recipient of renal transplant with good function (creatinine clearance >/=60 ml/min)
  • Stable immunosuppression consisting of any combination of sirolimus, tacrolimus for at least 6 months, without major complications
  • Ability to give informed consent.
  • Age greater than or equal to 18 years or less than or equal to 65 years
  • No evidence of liver disease (liver enzymes < twice the upper limit of normal)

Exclusion Criteria:

  • Age below 18 years and above 65 years
  • Significant cardiovascular disease, including non-correctable coronary artery disease and/or recent myocardial infarction(within last 12 months); extensive peripheral vascular disease not correctable by surgery, unstable angina
  • Untreated proliferative retinopathy.
  • Recent Cerebrovascular accident (within last 12 months)
  • Recent unresolved acute infection, or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or positive skin test for TB
  • Any history of malignancy, except squamous or basal skin cancer or in situ cancer of the cervix.
  • History of non-compliance, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin pump therapy.
  • Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment.
  • Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures for the duration of immunosuppressive therapy
  • Fasting C-peptide > 0.2 ng/ml
  • Creatinine > 25mg/l
  • Alkaline phosphatase, total bilirubin, Alanine Aminotransferase (ALT)or Aspartate Aminotransferase (AST) > twice the upper limit of normal
  • Significant liver disease (elevation of liver enzymes > twice the upper limit of normal for each of ALT and AST, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: islet transplantation
Islet transplantation
Procedure: islet transplantation
Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.
Other Names:
  • surgical catheterisation
  • percutaneous catheterisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 8% at one year after the transplantation
Time Frame: One year
Percent of insulin-independent patients with a Glycosylated Hemoglobin (HbA1c) under 8% at one year after injection of approximately 10,000 islets equivalents / kg (IE/kg).
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of adverse events
Time Frame: 1 year
The number of adverse events related to the procedure and to the immunosuppression
1 year
Number of severe episodes of hypoglycemia
Time Frame: 1 year
Number of severe episodes of hypoglycemia (requiring the use of third)
1 year
Evaluation of Diabetes complications
Time Frame: 1 year
Evaluation of Diabetes complications: retinopathy, neuropathy, nephropathy
1 year
Lipid metabolism
Time Frame: 1 year
Lipid metabolism assessed by measurement of total cholesterol and HDL cholesterol, triglycerides, ApoA1, apoB, apoE, free fatty acids and lipid.
1 year
Evaluation of kidney function
Time Frame: 1 year
Evaluation of kidney function (creatinine, creatinine clearance,proteinurie)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Marie-Christine VANTYGHEM, MD, University Hospital, Lille
  • Principal Investigator: Christian NOEL, MD, University Hospital, Lille
  • Principal Investigator: Julie KERR-CONTE, MD, Université de Lille 2

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (ESTIMATE)

May 14, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP 95/120
  • 98001 (OTHER: Sponsor)
  • DGS 980032 (OTHER: AFSSAPS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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