Status:
COMPLETED
Islet Allotransplantation With Steroid Free Immunosuppression
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Type 1 Diabetes
Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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). Aft...
Detailed Description
The short term effectiveness of islet transplantation for alleviating hypoglycemia and controlling glucose homeostasis while limiting or even avoiding the nedd for exogenous insulin has been establish...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00446264
Start Date
May 1 2003
End Date
February 1 2009
Last Update
April 27 2012
Active Locations (1)
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1
University Hospital of Lille
Lille, France, 59037