Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 10
- 主要终点
- Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
结局指标
主要结局
Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves
时间窗: 12 months
次要结局
- 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)