Combined Blood Stem Cell and Human Leukocyte Antigen (HLA) Haplotype Match Living Donor Kidney Transplantation
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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match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.
| Condition | Intervention |
|---|---|
|
Kidney Transplantation |
Procedure: Total Lymphoid Radiation with Donor hematopoietic stem Cell and Kidney Transplant |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion in HLA Haplotype Match Living Donor Kidney Transplantation |
- Long term freedom from transplant immunosuppressive drugs, safety, rate of infection, graft survival and patient survival. [ Time Frame: 5 years and indefinitely if possible ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
The goal of this study is for the recipients of a living related kidney transplant of one HLA haplotype to be withdrawn of immunosuppressive medication and become "tolerant "to their kidney graft.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 the end of the first year after the transplantation if the recipient meets withdrawing criteria (persistence of mixed chimerism more than 180 days, 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.
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All consenting adult (> 21 years of age) living donor renal transplant recipients at Stanford University Medical Center who have a one haplotype match donor.
- 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 posttransplant.
- The donor and the recipient must have an identical blood group.
Exclusion Criteria:
- 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 CMV, if donor is seropositive.
- Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3).
- PRA greater than 20% or demonstration of donor specific antibody (DSA)
- Prior organ transplantation
- High risk of primary kidney disease recurrence (i.e.FSGS)
Contacts and Locations| Contact: Asha Shori, CCRP | (650) 736-0245 | ashas@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Asha Shori, CCRP 650-736-0245 ashas@stanford.edu | |
| Contact: Stephan Busque, MD (650) 723-5454 sbusque@stanford.edu | |
| Study Director: John D Scandling | |
| Sub-Investigator: Judith Anne Shizuru | |
| Sub-Investigator: Dr. Marc L. Melcher | |
| Sub-Investigator: Richard T. Hoppe | |
| Sub-Investigator: Robert Lowsky | |
| Sub-Investigator: Julie M. Yabu | |
| Study Chair: Samuel Md Strober | |
| Principal Investigator: Stephan Busque | |
| Principal Investigator: | Stephan Busque | Stanford University |
More Information
Publications:
| Responsible Party: | Stephan Busque, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01165762 History of Changes |
| Other Study ID Numbers: | SU-06232010-6408, 18731 |
| Study First Received: | July 13, 2010 |
| Last Updated: | July 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Antilymphocyte Serum Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013