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

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I'm Interested

Trial ID: NCT03292445

Purpose

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 This research will change the immune system such that immunosuppressive drugs can be completely withdrawn or reduced to minimal dose without kidney rejection.

Official Title

Induction of Immune Tolerance by Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T Cell Transfusion in HLA Haplotype Matched Related and 3 Antigen HLA Matched Unrelated Living Donor Kidney Transplantation

Stanford Investigator(s)

Stephan Busque
Stephan Busque

Professor of Surgery (Abdominal Transplantation)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Marc L. Melcher
Marc L. Melcher

Professor of Surgery (Abdominal Transplantation)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Eligibility


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).

Intervention(s):

procedure: Immune tolerance after kidney transplant

drug: Donor blood stem cells and T cells

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Asha Shori, CCRP
650-736-0245