Overview

Tolerance by Engaging Antigen During Cellular Homeostasis

Status:
Recruiting
Trial end date:
2027-04-01
Target enrollment:
Participant gender:
Summary
Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine if: - it is safe to give mesenchymal stromal cells (MSCs) to kidney transplant recipients, and - the combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs can allow a kidney transplant recipient to slowly reduce and/or then completely stop all anti-rejection drugs, without rejection of their kidney (renal) allograft, a process called "immunosuppression withdrawal".
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Immune Tolerance Network (ITN)
PPD
Rho Federal Systems Division, Inc.
Treatments:
Abatacept
Alemtuzumab
Everolimus
Mycophenolic Acid
Prednisone
Sirolimus