Islet Transplantation Using a T-Cell Depleting Immunosuppression Induction Regimen
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 1 year post-transplant
研究概览
简要总结
City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on islet cell transplantation, an experimental procedure being evaluated as a treatment for patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing cells from organ donors and transplanting them into the liver of a patient with diabetes. Once transplanted, the islets produce insulin, which can improve blood sugar control and eliminate the need to inject insulin or use an insulin pump.
Anti-thymocyte globulin (ATG) and alemtuzumab (Campath) are anti-rejection medications that work by decreasing a patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted things like infections but can also attack transplanted cells and organs. Reducing the number of T-cells at the time of transplant may protect islets and improve long-term transplant success. In previous research studies, islet transplantation has been successful in reducing low blood sugar episodes, improving overall blood sugar control, and in some cases, allowing patients with type 1 diabetes to stop taking insulin.
The purpose of this study is to determine if islet cell transplantation using ATG or alemtuzumab, along with additional medications to prevent the body from rejecting the transplanted cells, is a safe and effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.
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 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Body Mass Index (BMI) > 33
- •Insulin requirements > 1.2 units/kg/day
- •Known sensitization to both rATG -and- alemtuzumab
- •Significant kidney dysfunction
- •Significant liver/gall bladder disease
- •Significant cardiovascular disease
- •Active proliferative retinopathy
- •High blood pressure despite appropriate treatment
- •High cholesterol/triglycerides despite appropriate treatment
- •Anemia or other blood disorders that require medical treatment
- •WBC <3,000/ul
- •Increased risk of bleeding, other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy
- •Recent unresolved acute infection (except for mild skin infection or nail fungal infection), or chronic infection
- •Epstein-Barr Virus (EBV) IgG negative
- •Any history of malignancy, except for completely resected squamous or basal cell carcinoma of the skin or in situ cancer of the cervix
- •Recent history of non-adherence to medical treatment, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin therapy
- •Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment
- •Previous organ/tissue transplant, except as noted above
- •Administration of live attenuated vaccines within 2 months of enrollment
- •Presence of a chronic disease that must be chronically treated with a contraindicated agent
- •Use of investigational agents within four weeks of enrollment
- •Active alcohol or substance abuse, including cigarette smoking
- •Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures prior to study entry and for as long as they are on immunosuppression medication, and women presently breast feeding are excluded
- •Individuals without health insurance
- •History of gastric bypass
- •Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial
研究组 & 干预措施
Single Arm Study
Allogenic Human Islet Cell Transplant with immunosuppression
干预措施: Allogenic Human Islet Cells (Biological)
Single Arm Study
Allogenic Human Islet Cell Transplant with immunosuppression
干预措施: Immunosuppressive Agents (Drug)
Single Arm Study
Allogenic Human Islet Cell Transplant with immunosuppression
干预措施: Gastrin 17 (Drug)
结局指标
主要结局
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 1 year post-transplant
时间窗: 1 year post-transplant
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 2 years post-transplant
时间窗: 2 years post-transplant
Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 5 years post-transplant
时间窗: 5 years post-transplant
次要结局
- Proportion of subjects who are free of severe hypoglycemic episodes AND have a hemoglobin A1c < or = 7.0%(+75 days, +6 months, +12 months, and +2, +3, +4 and +5 years post islet transplant)