Status:
UNKNOWN
Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.
Lead Sponsor:
Everett Meyer
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
ESRD
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 a...
Detailed Description
The goal of this study is for the recipients of a living related kidney transplant of one HLA haplotype to be withdrawn of immunosuppressive medication and become "tolerant "to their kidney graft.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...
Eligibility Criteria
Inclusion
- 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).
- Patients who agree to participate in the study and sign an Informed Consent.
- Patients who have no known contraindication to administration of rabbit ATG or radiation.
- Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 24 months post-transplant.
- ABO compatible.
Exclusion
- Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
- History of malignancy with the exception of non-melanoma skin malignancies.
- Pregnant women or nursing mothers.
- Serological evidence of HIV, Hepatitis B or Hepatitis C infection.
- Seronegative for Epstein-Barr virus, if donor is seropositive.
- Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3).
- Panel Reactive Antibody greater than 80% or demonstration of donor specific antibody (DSA).
- Prior organ transplantation.
- High risk of primary kidney disease recurrence (e.g atypical HUS). However, patients with primary FSGS will not be excluded.
Key Trial Info
Start Date :
July 14 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 14 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01165762
Start Date
July 14 2010
End Date
June 14 2025
Last Update
June 18 2023
Active Locations (2)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
University of Wisconsin
Madison, Wisconsin, United States, 53792-1690