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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 60
Updated:6/22/2018
Start Date:July 2010
End Date:June 2021
Contact:Asha Shori, CCRP
Email:ashas@stanford.edu
Phone:(650) 736-0245

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

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change the immune system such that immunosuppressive drugs can be completely withdrawn.

The goal of this study is for the recipients of a living related kidney transplant of one HLA
haplotype to be withdrawn of immunosuppressive medication and become "tolerant "to their
kidney graft. The recipient will receive a conditioning regimen composed of low dose
radiation to the lymphoid tissue (total lymphoid irradiation, TLI) and anti-thymocyte
globulin (ATG) at the time of transplant. They will then be infused with purified "stem cell"
and T-cell from their kidney donors 2 weeks after the transplant to try to achieve mixed
chimerism of their white blood cells with the donor (the recipient would have a mixture some
of the with blood cells of the donor and theirs in their blood). The kidney donor has to
provide peripheral stem cell 6-8 weeks before kidney donation. It is an outpatient procedure
done using peripheral veins after treatment with G-CSF (filgrastim).Immunosuppressive
medication will be decreased gradually and possibly stopped by 1 1/2 year after the
transplantation if the recipient meets withdrawing criteria (persistence of mixed chimerism
more than 18 months, no episode of rejection and no rejection on surveillance kidney biopsy).
Potential candidates need to be approved for kidney transplant and available for close
follow-up at Stanford University Medical Center.

Inclusion Criteria:

1. All consenting adults who are 18 to 60 years, living donor transplant candidates and
have a happlotype related living donor or > 2 HLA antigen matched, unrelated, living
donor (including at least one HLA-DR antigen match pus 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
radiation.

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

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
(DSA).

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.
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: John D Scandling
Phone: 650-736-0245
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