Status:
TERMINATED
Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ 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 main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. The o...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus
- Disease duration \> 5 years
- ketose antecedents
- Basal and stimulated plasma C-\< 0.2 ng/ml,\<0.06 nmol/l (glycemia must be measured simultaneously\_ 1.20 g/l or 6.6 mM, stimulation with glucagon IV 1 mg -Measured at à T0 and T 6 min)
- Established kidney graft ≥ 6 months
- Current creatinine clearance: ≥ 50 ml/min/1.73 m² and Proteinuria \< 0.5 g/24h
- HbA1C\< 12%
Exclusion
- Hemostasis problems
- Documented hepatic pathology
- Patient under 18 or over 65 year-old
- Women with body weight over 70 kg (tolerance of 2 kg between inclusion day and transplantation day) or BMI \> 26
- Men with body weight \> 75 kg (tolerance of 3 kg between inclusion day and transplantation day) or BMI \> 26
- insuline needs \> 0.7 U/kg/j or 50 U/j
- Serious life-threatening pathology
- untreated hyperlipidemia
- Hypersensitivity to drugs rapamycine-alike
- Liver disease (transaminases or total bilirubin ≥ 3N)
- Failure to communicate or cooperate with the investigator
- Exclusion criteria that are specific to the use of Rapamycine
- Hypercholesterolemia (\> 350mg/dl, 9,1 mmol/l) not controlled
- Hypertriglyceridemia (\> 500 mg/dl, 5,6 mmol/l) not controlled
- Leukocytes \> 4500 /mm3 , neutrophils \> 2000/ mm3, platelets \> 100000/ mm3
- Any clinical or biological pathology that could interfere with the study
- Past or present neoplasia (with the exception of non melanoma skin cancers)
- Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. Low-dose aspirin is permitted.
- Pregnancy, lactation, pregnancy project or absence of efficient contraception
- Any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00639600
Start Date
June 1 2008
End Date
May 1 2010
Last Update
May 31 2010
Active Locations (7)
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1
University Hospital
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