TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University

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

22 Participants
are divided into 1 treatment group

Sponsors and collaborators

Stanford University

Lead sponsor

California Institute for Regenerative Medicine (CIRM)

Collaborator

Northwestern University

Collaborator