Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.
NCT03591302 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2022-05-10
Summary
The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.
Conditions
- Immune Tolerance
Interventions
- BIOLOGICAL
-
Hematopoietic cell transplantation
Transplantation of hematopoietic stem cells from living donor.
- RADIATION
-
Total Lymphoid irradiation
Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.
Sponsors & Collaborators
-
Stephan Busque
lead OTHER
Principal Investigators
-
Samuel Md Strober, MD · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-13
- Primary Completion
- 2025-10-01
- Completion
- 2025-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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