Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.


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Trial ID: NCT01165762


The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone marrow Transplantation are enrolling patients into a research study to determine if donor stem cells given after a living related one Haplotype match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.

Official Title

Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion in HLA Haplotype Match 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

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)


Inclusion Criteria:

   1. All consenting adults who are 18 to 60 years, living donor transplant candidates and
   have a haplotype related living donor or > 2 HLA antigen matched, unrelated, living
   donor (including at least one HLA-DR antigen match plus at least one antigen match of
   either HLA-A or HLA-B).

   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

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

   5. ABO compatible.

Exclusion Criteria:

   1. Previous treatment with rabbit ATG or a 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 than 80% or demonstration of donor specific antibody

   8. Prior organ transplantation.

   9. High risk of primary kidney disease recurrence (e.g atypical HUS). However, patients
   with primary FSGS will not be excluded.


drug: Immune Tolerance


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Asha Shori, CCRP