Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft

Phase 1

Terminated

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT00639600
• Lead Sponsor: University Hospital, Grenoble

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 with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

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 other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.

Study Timeline

• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Study Start: 2008-06
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2010-05-28
• Last Update Posted: 2010-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves	12 months

Secondary Outcome Measures

Name	Time	Method
Tolerance (Measurement of portal pressure during islet injection) Quality of life (Questionnaires SF-36 and DQOL at inclusion time, then every 6 months during their waiting period and then 6 months and 12 months after transplantation) Costs	12 months

Trial Locations

Locations (3)

University Hospital, Department of Endocrinology; 🇫🇷 Strasbourg, France

University Hospital; 🇫🇷 Besancon, France

University Hospital, Department of Surgery; 🇨🇭 Geneva, Switzerland