Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft (GRAGIL1)

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Procedure: human pancreatic islet transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00639600

95/CHUG/10/C2

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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