RecruitingPhase 1NCT03591302

Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.

Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion to Withdraw Immunosuppressive Drugs From Recipients of a Previous HLA Matched Living Donor Kidney Transplantation .

Sponsor

Stephan Busque

Enrollment

25 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Immune Tolerance

Summary

The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection.
Patients who agree to participate in the study and sign an Informed Consent
The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent.
The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford.
Patients who have no known contraindication to the administration of rabbit ATG or radiation
Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant.

Exclusion Criteria7

Known allergy to 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 (HepBsAg+) or Hepatitis C infection.
Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (platelet count < 100,000/mm3)
Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease.
Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease or interstitial fibrosis/Tubular Atrophy (IF/TA) score greater than 1.