Tolerance Through Mixed Chimerism (Sip-Tego)
This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.
• Male or female 18-65 years of age.
• Subjects with chronic kidney disease stage V (GFR\<15ml/min/1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.
• Candidate for a living-donor renal allograft from an HLA matched or mismatched donor
• First or second renal transplant.
• EBV Seropositive
• Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation
• Ability to understand and provide informed consent.
• Negative COVID-19 test during screening and two days prior to procedure
• Male or female 18-70 years of age.
• For females of childbearing potential: a serum pregnancy test showing negative results.
• Excellent health per conventional pre-donor workup (medical and psychosocial evaluation)
• Acceptable laboratory parameters (hematology in normal or near-normal range; Liver function \<2 times the upper limit of normal, and normal creatinine).
• Negative for viral infection with HBV (HbsAg and NAT), HIV (antibody and NAT), HCV (NAT), or HTLV-1.
• Cardiac/pulmonary function within normal limits (CXR, ECG).
• Ability to understand and provide informed consent.
• Meets standard institutional criteria for bone marrow aspiration and kidney donation.
• Negative COVID-19 test during screening and two days prior to procedure