About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs
Treatment groups
Sponsors and collaborators
Stanford University
Lead sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
Northwestern University
Collaborator