Type 1 Diabetes Clinical Trial
Official title:
Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression
Verified date | January 2018 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | April 2016 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Lille | Lille | Nord |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 8% at one year after the transplantation | 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 | The number of adverse events | The number of adverse events related to the procedure and to the immunosuppression | 1 year | |
Secondary | Number of severe episodes of hypoglycemia | Number of severe episodes of hypoglycemia (requiring the use of third) | 1 year | |
Secondary | Evaluation of Diabetes complications | Evaluation of Diabetes complications: retinopathy, neuropathy, nephropathy | 1 year | |
Secondary | Lipid metabolism | Lipid metabolism assessed by measurement of total cholesterol and HDL cholesterol, triglycerides, ApoA1, apoB, apoE, free fatty acids and lipid. | 1 year | |
Secondary | Evaluation of kidney function | Evaluation of kidney function (creatinine, creatinine clearance,proteinurie) | 1 year |
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