Islet Allotransplantation With Steroid Free Immunosuppression

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in 2000 new standards for islet transplantation in patients with brittle T1D by achieving insulin independence in 80 percent of patients. These seminal results have however proved much more difficult to duplicate than initially expected.

This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe T1D.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Daclizumab; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• type 1 diabetes documented for more than 5 years

• arginine stimulated C-peptide lower than 0.2 ng/mL

• one of the following:hypoglycemia unawareness OR metabolic lability documented by one or more severe hypoglycemias or two or more hospital admissions for ketoacidosis within the previous year.

Exclusion Criteria:

• body mass index greater than 28 kg/m2

• non stable arteriopathy or heart disease

• active infection

• previous transplantation

• hyperimmunization

• insulin daily needs above 1.2 U/Kg

• creatinine clearance below 60 ml/mn or urinary albumin excretion above 300 mg/d

• malignancy

• smoking

• desire for pregnancy

• psychiatric disorders

• lack of compliance