NCT00623610已完成1 期
Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes
AZ-VUB4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2000年9月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Evidence of clinically relevant beta cell function.
研究概览
简要总结
To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged survival of beta cell allografts in type 1 diabetic patients with early chronic complications of diabetes.
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 insulin-dependent diabetic patients in relatively good general condition
- •non-smoker
- •body weight < 80 kg
- •C-peptide < 0.03 nmol/l (<0.09 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
- •EBV antibody positive
- •cooperative and reliable patient giving informed consent by signature; the patient should be informed in sufficient detail on the content and procedure of the protocol, indicating potential risks of intervention and of immunosuppressive therapy; the patient should also be informed that withdrawal of immunosuppressive therapy in patients with persistent plasma C-peptide positivity may result in subsequent loss of ß-cell graft function; the ß cell implant should be identified as a clinical trial
排除标准
- •history of thrombosis or pulmonary embolism
- •abnormal liver function
- •HLA antibodies
结局指标
主要结局
Evidence of clinically relevant beta cell function.
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
早期 1 期
Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1DType 1 Diabetes MellitusNCT03632759Carla Greenbaum, MD16
已完成
2 期
Combination Drug Therapy Followed by Single Drug Steroid Free Therapy to Prevent Organ Rejection in Kidney TransplantationKidney TransplantationNCT00076570National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)31
已完成
2 期
Rituximab for Prevention of Rejection After Renal TransplantationKidney TransplantationNCT00565331Radboud University Medical Center280
Unknown
2 期
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung CancerNon-small Cell Lung CancerNCT01481259People's Hospital of Guangxi120
已完成
2 期
Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic AnemiaAplastic AnemiaNCT01231841The Cleveland Clinic20