Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 8% at one year after the transplantation
研究概览
简要总结
This single center phase 2 clinical trial, is designed for confirming the efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with previous kidney transplantation.
详细描述
The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus have been recognized.
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.
The study primary efficacy endpoint is graft survival defined as insulin independence and HbA1c < 8% at 1 year post first transplant. Secondary outcomes are graft function and metabolic control
The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide and diagnosis of diabetes for at least 5 years.
- •Recipient of renal transplant with good function (creatinine clearance >/=60 ml/min)
- •Stable immunosuppression consisting of any combination of sirolimus, tacrolimus for at least 6 months, without major complications
- •Ability to give informed consent.
- •Age greater than or equal to 18 years or less than or equal to 65 years
- •No evidence of liver disease (liver enzymes < twice the upper limit of normal)
排除标准
- •Age below 18 years and above 65 years
- •Significant cardiovascular disease, including non-correctable coronary artery disease and/or recent myocardial infarction(within last 12 months); extensive peripheral vascular disease not correctable by surgery, unstable angina
- •Untreated proliferative retinopathy.
- •Recent Cerebrovascular accident (within last 12 months)
- •Recent unresolved acute infection, or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or positive skin test for TB
- •Any history of malignancy, except squamous or basal skin cancer or in situ cancer of the cervix.
- •History of non-compliance, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin pump therapy.
- •Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment.
- •Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures for the duration of immunosuppressive therapy
- •Fasting C-peptide > 0.2 ng/ml
- •Creatinine > 25mg/l
- •Alkaline phosphatase, total bilirubin, Alanine Aminotransferase (ALT)or Aspartate Aminotransferase (AST) > twice the upper limit of normal
- •Significant liver disease (elevation of liver enzymes > twice the upper limit of normal for each of ALT and AST, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).
研究组 & 干预措施
islet transplantation
Islet transplantation
干预措施: islet transplantation (Procedure)
结局指标
主要结局
Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 8% at one year after the transplantation
时间窗: One year
Percent of insulin-independent patients with a Glycosylated Hemoglobin (HbA1c) under 8% at one year after injection of approximately 10,000 islets equivalents / kg (IE/kg).
次要结局
- The number of adverse events(1 year)
- Number of severe episodes of hypoglycemia(1 year)
- Evaluation of Diabetes complications(1 year)
- Lipid metabolism(1 year)
- Evaluation of kidney function(1 year)