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determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor.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).
Males and females ages 18 years and older with a pre- existing kidney transplant from an HLA-matched living donor.
Pre-existing living kidney transplant must be within 3 months to 5 years from date of scheduled HPSC infusion.
No history of rejection with current HLA matched kidney transplant.
Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection.
Donor is identical twin.
Major ABO incompatibility with donor
Positive HLA Donor-Specific Antibody (DSA)
History of multi-organ transplantation
Single group
Conditioning and Stem cell infusion
Combination productPatients 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
Incidence of successful discontinuation of immunosuppression
To determine whether patients with pre-existing kidney transplants from a haploidentical living donor can be withdrawn from immunosuppressive drugs while maintaining stable graft function within 12 months of hematopoietic stem cell infusion from the same HLA-identical living donor, preceded by conditioning with TLI and ATG.
Incidence of allograft rejection
To determine the percentage of subjects with graft rejection within 48 months post-HPSC infusion defined as (1) meets Banff criteria for rejection on biopsy performed to confirm clinical suspicion of rejection or (2) clinical suspicion of rejection demonstrating response to corticosteroids in absence of biopsy when confirmatory biopsy contraindicated or declined.
Graft survival
To determine graft survival within the first 24 months post-HPSC infusion.
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