Investigation of Safety and Efficacy Study of Islets Xenotransplantation for Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Blood glucose
研究概览
简要总结
The neonatal pig islets will be used as donor culturing with our modified culture medium. At the same time the autologous T regulatory cells will be used to induce specific immune tolerance for porcine islets grafts combined the costimulation of T cell activation channel blockers. The treatment for type 1 diabetes will be evaluated the efficacy and safety.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 18 to 40 years of age;
- •Type 1 diabetes mellitus for at least 5 years;
- •Body weight 40 to 60kg;
- •Ability to provide written informed consent;
- •Manifest signs and symptoms that are severe enough to be incapacitating;
- •Patients with poor diabetes control (HbA1c > 9% );
- •Patients have diabetes ketoacidosis or hypoglycemia more than once
排除标准
- •Age < 18 years or > 60 years;
- •Diabetes history < 5 years;
- •Body weight > 80 kg;
- •Exogenous insulin requirement > 1 unit/kg/day;
- •Blood test: hemoglobin male < 90g/l, female < 90 g/l) or Wbc <3×109/L, lymphocyte <1.5×10^9/L; or platelet < 80×10^9/L; activated- partial-thromboplastin-time （APTT） > normal value (31-43s)10s;
- •Liver dysfunction;
- •Kidney dysfunction;
- •Cardiopulmonary dysfunction;
- •Combined mental illness, cancer, infection, severe trauma, pancreatitis, surgery or other stress situations for patients; gastric ulcer patients, any bleeding disorders, tuberculosis infection and active infection including hepatitis B, hepatitis C, HIV, or John Cunningham virus;
- •Serological detection Epstein-Barr virus (EBV) or Cytomegalovirus (CMV)negative;
- •Patient have taken immunosuppressant in recent one year With high incidence of malignancy in three generation;
- •Women not using effective contraception of childbearing age, or planning pregnancy in nearly two years or being pregnant or lactating;
- •Patients can not comply with the research program to complete the diagnosis and treatment;
- •Patients not be passed by Ethics committee
结局指标
主要结局
Blood glucose
时间窗: 1 year
Before and after transplantation the patient will be tested the blood glucose. If the blood glucose within 24 hours is stable and no occurrence of diabetic ketoacidosis and hypoglycemia.Thirty percent reduction of exogenous insulin requirement will be considered as effective.
次要结局
- Porcine C-peptide(1 years)
- Hemoglobin A1c(1 years)
- AST(1 years)
- Scr(1 years)
- Cytokine detection(1 years)
- ALT(1 years)
- BUN(1 years)
- MRI for liver(1 years)
- Immune cells detection(1 years)
- Ultrasonic examination for liver(1 years)
- Virus detection(2 years)
研究者
Wei Wang,MD
Director of Cell Transplantation and Gene Therapy Institute
Central South University