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

Trial ID or NCT#

NCT01165762

Status

not recruiting iconNOT RECRUITING

Purpose

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match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.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

Eligibility Criteria

Ages Eligible for Study: 18 to 60
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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 radiation.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.
    1. Exclusion Criteria:
  2. 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.
Exclusion Criteria:
  1. 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.
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Investigator(s)

Stephan Busque
Stephan Busque
Transplant surgeon, Kidney transplant surgeon, Pancreas transplant surgeon
Professor of Surgery (Abdominal Transplantation), and by courtesy, of Medicine (Nephrology)

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Contact

Asha Shori, CCRP
650-736-0245

View on ClinicalTrials.gov