Inducing Graft Tolerance in HLA Haplotype Matched Related and 3 Ag Matched Unrelated Living Donor Kidney Transplantation

• Status: Recruiting
• Trial end date: 2024-02-14
• Target enrollment: 0
• Participant gender: All

Summary

This research study is to determine if donor blood stem cells given after living, related, HLA antigen (Ag) haplotype match or living, unrelated donor kidney transplantation. Minimal HLA antigen matching will include matching of 2 HLA antigens that can be either HLA A, B, and /or DR. This research will change the immune system such that immunosuppressive drugs can be completely withdrawn or reduced to minimal dose without kidney rejection.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samuel Strober
• Collaborators: California Institute for Regenerative Medicine; California Institute for Regenerative Medicine (CIRM)
• Treatments: Antilymphocyte Serum; Immunosuppressive Agents

Criteria

Inclusion Criteria:

1. All consenting adults (18 years of age) living donor renal transplant recipients at Stanford University Medical Center who have a one haplotype match donor.

2. Patients who agree to participate in the study and sign an Informed Consent.

3. Patients who have no known contraindication to administration of rabbit ATG or radiation.

4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 24 months posttranplant.

Exclusion Criteria:

1. Previous treatment with rabbit ATG or known allergy to rabbit proteins.

2. History of malignancy with the exception of non-melanoma skin malignancies.

3. Pregnant women or nursing mothers.

4. Serological evidence of HIV, Hepatitis B or Hepatitis C infection.

5. Seronegative for Epstein-Barr virus , if donor is seropositive.

6. Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3)

7. Panel Reactive antibody greater then 20% or demonstration of donor specific antibody (DSA).

8. Prior organ transplantation.

9. High risk of primary kidney disease recurrence (i.e. primary FSGS).