A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT03284242|
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : October 3, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Kidney Transplant||Procedure: Apheresis||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single intravenous infusion of autologous, ex vivo, expanded Treg cells in renal transplant recipients who are on Everolimus-based immunosupressive therapy.|
|Masking:||None (Open Label)|
|Official Title:||Tolerance Induction Using Autologous Regulatory T Cell Infusion and Zortress (Everolimus) in Renal Transplant Recipients: a Pilot Study|
|Actual Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: 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.
Collect white blood cells to isolate Treg cells for expansion. Once the blood cells are collected the cells will be cultured in the laboratory and will be expanded. After approximately 3 weeks in culture, the cells will have increased in number and be ready for the autologous Treg cell infusion.
- Changes in Tregs Infusion Toxicities [ Time Frame: 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 [ Time Frame: for 2 years from the start of the study ]Creatinine level measurement
- Changes In Steroid Resistance Rejection Rates [ Time Frame: 1, 6 and 12 months post Tregs infusion ]Laboratory measurement
- Infectious Complications [ Time Frame: for 2 years from the start of the study ]Laboratory measurement
- Treg cell measurements within the allograft [ Time Frame: 6 to 12 weeks post transplant ]Renal biopsy
- Circulating T cell subset measurements [ Time Frame: twice a week for 4 weeks then weekly for 3 months ]laboratory analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284242
|United States, Kentucky|
|University of Kentucky Medical Center||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Roberto Gedaly, MD 859-323-1691 email@example.com|
|Principal Investigator:||Roberto Gedaly, MD||University of Kentucky|