A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients

• Status: Completed
• Trial end date: 2024-04-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roberto Gedaly
• Collaborator: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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