This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.
All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.
Patients who agree to participate in the study and sign an Informed Consent.
Patients who have no known contraindication to administration of rabbit ATG or radiation.
Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant
Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
History of malignancy with the exception of non-melanoma skin malignancies.
Pregnant women or nursing mothers.
Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.
Single group
Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs
Biological/VaccineLiving donor kidney transplant recipients will receive after a preparatory regimen of total lymphoid irradiation, total body irradiation and anti-thymocyte globulin an infusion of purified donor CD34+ of \>10 x10\^6 cells /Kg, 100 x 10\^6 donor T cell/ Kg and and an escalated dose of recipient Tregs starting at 25 x10\^6/Kg.
Count of participants with sustained mixed chimerism of >25% at 18 months
Chimerism is defined as the co-existence of the immune cell from both the donor and the recipient.
Count of participants able to withdraw from immunosuppressive drugs without evidence of rejection at 18 months
Count of participants with adverse events associated with the infusion of the Tregs cell product
Count of participants with bacterial, viral, or fungal infections
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Stanford University
Lead sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
Northwestern University
Collaborator
