A Single-armed, Unblinded, Non-randomized Feasibility Study of Hematopoietic Stem Cell Infusion Following a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Anti-thymocyte Globulin (ATG) in Patients With a Pre-existing, Well-functioning HLA-matched Kidney Transplant
University of California, Los Angeles
Summary
The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).
Description
Immunological tolerance through combined kidney and HPSC transplant has been demonstrated at few centers of excellence within the United States. The ultimate aim of these protocols is to liberate patients from lifelong immunosuppression. Thus far, protocols have been limited to HLA-identical donor recipient pairs, undergoing simultaneous kidney transplant and HPSC infusion. In all protocols, the recipient undergoes a conditioning regimen to optimize engraftment. Our protocol employs a conditioning regimen of TLI and ATG. There are many more patients with pre-existing well-functioning HLA-iden…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Recipient Inclusion Criteria: 1. Males and females ages 18 years and older with a pre- existing kidney transplant from an HLA-matched living donor. 2. Pre-existing living kidney transplant must be within 3 months to 5 years from date of scheduled HPSC infusion. 3. No history of rejection with current HLA matched kidney transplant. 4. Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection. 5. Stable renal function determined per investigator discretion. 6. Agreement to participate in the study and ability to give informed consent.…
Interventions
- Combination ProductConditioning and Stem cell infusion
Patients will undergo a conditioning with TLI and ATG, followed by infusion of hematopoietic stem cells from the same HLA-identical donor that provided the original kidney
Location
- UCLALos Angeles, California