Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.
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match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.
|Study Design:||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 ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Immune Tolerance, Kidney transplantation
Induction of immune tolerance in Haplotype matched living donor kidney transplantation.
Drug: Immune Tolerance
Immune tolerance Kidney and hematopoietic cell transplantation with a conditioning regimen of total lymphoid irradiation and antithymocyte globulin followed by immunosuppressive drugs for 18 months. Immunosuppressive drugs are stopped if stable chimerism is achieved and there is no rejection of the transplant kidney.
The IDE used in this study is the column used for hematopoietic cell sorting.
Other Name: Kidney transplantation
The goal of this study is for the recipients of a living related kidney transplant of one HLA haplotype to be withdrawn of immunosuppressive medication and become "tolerant "to their kidney graft.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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165762
|Contact: Asha Shori, CCRP||(650) email@example.com|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Asha Shori, CCRP 650-736-0245 firstname.lastname@example.org|
|Principal Investigator: 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|
|Principal Investigator: Samuel Md Strober|
|Principal Investigator: Stephan Busque|
|Principal Investigator:||Stephan Busque||Stanford University|