Status:
COMPLETED
Human Islet Transplantation in Brittle Type 1 Diabetes Mellitus. The GRAGIL 2 Study.
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Alfediam
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients w...
Detailed Description
The general objective is to demonstrate the beneficial effect of islet allotransplantation in patients with brittle type 1 diabetes with no endogenous insulin secretion, for whom the risk of the spont...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Type 1 diabetes mellitus
- Disease duration \> 5 years
- Despite intensive insulin therapy with tight endocrinologist supervision, persistence of the following conditions : hypoglycemia unawareness (\< 54 mg/dl) ; brittleness with at least two episodes of severe hypoglycemia ((defined by the need for assistance to correct the blood glucose level) or ketoacidosis per year , or often enough that the diabetologist judges the frequency to be life-threatening, the risk of transplantation and immunosuppression being judged to be less than the risk of the spontaneous course of uncontrolled diabetes
- Basal and stimulated plasma C-peptide \< 0.2 ng/ml
- Creatinine clearance ≥ 50 ml/min/1.73 m2 and proteinuria \< 0.5 g/24h
- Exclusion criteria:
- Severe cardiovascular disease (recent myocardial infarction, unstable coronaropathy…)
- Severe systemic infection, including hepatitis C or B viral infection, HIV infection or tuberculosis
- Past or present neoplasia (with the exception of non melanoma skin cancers)
- Body weight \> 70 kg in women and BW \> 75 kg in men or BMI \> 26
- Stimulated C-peptide ≥ 0.3 ng/ml upon Glucagon or Arginine stimulation
- Age \< 18 years or \> 65 years
- Creatinine clearance \< 50 ml/min/1.73 m2
- Albuminuria \> 300 mg /24h or proteinuria \> 0.5 g/24h
- Hemoglobinemia \< 120 g/l in women or \< 130 g/l in men
- Liver disease (enzymes \> 1.5 N) such as cirrhosis or hepatitis
- Liver hemangioma
- Untreated proliferating diabetic retinopathy
- Pregnancy, lactation, pregnancy project or absence of efficient contraception
- Previous transplantation or immunization as judged by anti-HLA antibodies (\> 20%)
- Insulin needs \> 0.7 IU/kg/d or \> 50 IU
- HbA1c \> 12 %
- Any medical condition needing the chronic use of steroids
- Addison disease
- Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. Low-dose aspirin is permitted. coagulation disorders contraindicating the procedure, such as platelet count \< 100000/mm3.
- Serious life-threatening disease
- Medical or surgical history potentially influencing the absorption, distribution, metabolism and clearance of drugs
- Uncontrolled hypercholesterolemia (\> 350 mg/dl, 9.1 mmol/l) or hypertriglyceridemia (\> 500 mg/dl, 5.6 mmol/l)
- Leukocytes \< 4500/mm3, neutrophils \< 2000/mm3, platelets \< 100000/mm3
- Any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse
- Poor therapeutic observance
- Failure to communicate or cooperate with the investigator
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00321256
Start Date
July 1 2003
End Date
July 1 2007
Last Update
March 2 2012
Active Locations (6)
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1
University Hospital, Department of Endocrinology
Besançon, France, 25000
2
University Hospital, Department of Endocrinology
Grenoble, France, 38043
3
University Hospital, Department of Endocrinology
Lyon, France, 69000
4
University Hospital, Department of Endocrinology
Montpellier, France, 34000