Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation (NCT01123187) | Clinical Trial Compass
CompletedNot Applicable
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
France14 participantsStarted 2003-03
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
What they're measuring
1
Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 8% at one year after the transplantation