Tolerance Induction Using Autologous Regulatory T Cell Infusion and Zortress (Everolimus) in Renal Transplant Recipients: a Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Infectious Complications
研究概览
简要总结
This study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg cells) to renal transplant recipients who are using Zortress (Everolimus) as immunosuppressive therapy.
Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection. Treg cells are collected from a participant's blood through a procedure called apheresis. Treg cells are a type of white blood cells that are able to suppress the activity of other immune cells responsible for organ rejection. The investigator plans to enroll 12 participants at the University of Kentucky.
详细描述
The purpose of this research study is to learn alternative ways to control the body's immune responses after renal transplantation. The investigator's goal is to prevent or reduce the side-effects of long-term immunosuppressive therapy.
By doing this study, the investigator hopes to learn how safe and effective infusing autologous Treg cells, after renal transplantation, to renal transplant recipients who are taking Zortress (Everolimus) to control the immune response.
Individuals who decide to take part in this research study and are eligible to start, will be followed for 1 year after their transplant. The research procedures will be conducted at the University of Kentucky Medical Center and require nine study visits. One of the study visits requires an overnight stay. Participants will be admitted to the University of Kentucky Center for Clinical and Translational Science (CCTS) inpatient research unit for this study visit. Depending on the frequency of an participant's post-transplant clinic visits, some of the study visits could be done at the same time as their regular clinic visits. If not, they will occur in the transplant clinic or in the University of Kentucky Center for Clinical and Translational Science (CCTS) outpatient research unit.
The total amount of time required for participation in the study will be up to 40 hours over 1 year. The total amount of blood taken for the study will be about 14 tablespoons (200ml/6.5 ounces) over 1 year.
STUDY PROCEDURES:
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
- •Fluent in English able to understand and provide informed consent
- •End stage renal disease listed for primary solitary kidney transplant
- •Willing to participate in the study and comply with study requirements
- •Female participants must agree to use 2 different birth control methods
排除标准
- •History of previous organ, tissue or cell transplant
- •Known sensitivity to Sirolimus, Everolimus, Tacrolimus or MMF
- •Previous chronic use of systemic glucocorticoids or other immunosuppression, or biologic immunomodulators
- •Significant or active infection: HIV, Hepatitis B and C
- •Active cancer or history of cancer within 3 years of screening
- •Participation in other study that involved investigational drug or regimens in the preceding 12 months
- •History of delayed or abnormal wound healing
- •Delayed graft function
- •Chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation
- •Pregnant or breastfeeding or refusal to us birth control
- •Inability or unwillingness to comply with study protocol or procedures
- •Chronic use of anticoagulants
- •Blood transfusion 3 months prior to transplant
- •History of non-compliance
研究组 & 干预措施
Autologous Treg Infusion
This will be a single intravenous (IV) infusion. A participant's own expanded regulatory T cells will be added to Albumin, and administered to them. The amount of the solution will be approximately 300 ml and the infusion will take about 3 to 4 hours.
干预措施: Treg (Drug)
结局指标
主要结局
Infectious Complications
时间窗: for 2 years from the start of the study
Laboratory measurement
Changes in Tregs Infusion Toxicities
时间窗: Immediately following Tregs infusion and again within 24 hours after Tregs infusion
Laboratory measurement and observed toxicities immediately and with in 24 hours post infusion of Tregs.
Changes in Kidney Function
时间窗: for 2 years from the start of the study
Creatinine level measurement
Changes In Steroid Resistance Rejection Rates
时间窗: 1, 6 and 12 months post Tregs infusion
Laboratory measurement
次要结局
- Circulating T cell subset measurements(twice a week for 4 weeks then weekly for 3 months)
- Treg cell measurements within the allograft(6 to 12 weeks post transplant)
研究者
Roberto Gedaly
Sponsor/Investigator
University of Kentucky