Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- hemorrhage
研究概览
简要总结
Islet transplantation is one of the effective and promising options for type 1 diabetes mellitus treatment1-4. The liver is the primary target location for infusion and portal vein catheterization is generally used. Percutaneous transjugular, percutaneous transhepatic, laparoscopically transmesenteric and laparoscopically transumbilical approaches were often utilized to access the portal. Current islet infusion approach via portal vein of liver has various defects. Percutaneous trans-hepatic puncture is risk of possible severe hemorrhage and portal thrombosis. The laparoscopic entry techniques require longer surgical duration and have an increased rate of catheterization failure. Moreover, the catheters were not allowed to indwell for subsequent infusions.
In the current study, the investigators aim to performed open surgery, catheterized the umbilical vein and infused islets into the portal vein. The catheter was indwelled for one month after surgery. Therapeutic effects, surgical parameters and complications were observed to evaluate feasibility and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 18 to 60 years of age.
- •Ability to provide written informed consent.
- •Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(2007) on the Diagnosis and classification of Diabetes Mellitus.
- •manifest signs and symptoms that are severe enough to be incapacitating.
- •Basal C-peptide<0.5ng/mL
- •patients with poor diabetes control (HbA1c >7% but <12%)
- •progressive diabetic complications.
排除标准
- •age <18 years or >60 years
- •diabetic history <5 years
- •body weight >80kg
- •exogenous insulin requirement >1 unit/kg/day
- •severe anemia (male <8g/dl, female <7g/dl)
- •low white blood cell count (<3000/dl)
- •liver dysfunction
- •Symptomatic peptic ulcer disease
- •Any malignancy
- •Active infection including hepatitis B, hepatitis C, HIV, or TB
- •panel reactive antibody >20%
- •Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
结局指标
主要结局
hemorrhage
时间窗: 1 month
次要结局
- Infection(6 month)
- Exogenous insulin requirement(1 year)
- Glucose(1 year)
- C-peptide(1 year)
研究者
Jianming Tan
Director, Organ transplantation intitute
Fuzhou General Hospital