Open Multi-Center Randomized Study to Compare Safety and Efficacy of Islet Transplantation Using The Intraportal or Intramuscular Site in Simultaneous Islet and Kidney Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 主要终点
- C-peptide derived from the Mixed Meal Tolerance Test (MMTT)
研究概览
简要总结
Islet transplantation is a promising treatment of type 1 diabetes in selected cases. Results are however hampered by a relatively low number of islets surviving the transplantation into the liver, which currently is the site for transplantation. In the present study we compare a new transplantation site (intramuscular in the arm) to the golden standard (the liver) in patients undergoing kidney transplantation from the same donor. In half of the intramuscular transplanted patients, the islets will be mixed with mesenchymal stemcells from the recipient to, possibly, improve the immunological aspects of the transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 18 to 65 years of age.
- •Ability to provide written informed consent.
- •Mentally stable and able to comply with the procedures of the study protocol.
- •Clinical history compatible with type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years at the time of enrolment.
- •Absence of stimulated C-peptide <0.1 nmol/L in response to a MMTT.
- •All subjects must have received adequate medical treatment of their diabetes under the guidance from an experienced diabetologist.
- •All subjects must have renal failure and be eligible for renal transplantation according to local criteria.
排除标准
- •Patients with prior organ transplants
- •Patients that qualify for local simultaneous pancreas-kidney transplantation program and who prefer that option
- •Patients with body mass index BMI >
- •Insulin requirement > 1 Unit/kg/day. If the patient is on peritoneal dialysis the same limit is set when the extra carbohydrates in the dialysis fluids have been accounted for.
- •Consistently abnormal liver function tests ( > 1.5 x the upper limit of normal on two consecutive measurements > 2 weeks apart)
- •Unstable diabetic retinopathy
- •Hypercoagulability disorder or coagulopathy or International normalized ratio (INR)>1.5
- •Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- •Patients with unstable cardiovascular status
- •Patients with active infections, unless treatment is not judged necessary by the investigators
- •Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
结局指标
主要结局
C-peptide derived from the Mixed Meal Tolerance Test (MMTT)
时间窗: 365 days (+/-14) after kidney transplantation
Percentage of patients in each study group reaching a systemic C-peptide derived from the MMTT above 0.1 nmol/L basal (fasting) and 90-min 0.3 nmol/L 75 (+/-5) and 365 days (+/-14) after kidney transplantation
次要结局
未报告次要终点