Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.
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|ClinicalTrials.gov Identifier: NCT01165762|
Recruitment Status : Active, not recruiting
First Posted : July 20, 2010
Last Update Posted : July 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|ESRD||Drug: Immune Tolerance||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion in HLA Haplotype Match Living Donor Kidney Transplantation|
|Actual Study Start Date :||July 14, 2010|
|Estimated Primary Completion Date :||June 14, 2023|
|Estimated Study Completion Date :||June 14, 2025|
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
- Long term freedom from transplant immunosuppressive drugs, safety, rate of infection, graft survival and patient survival. [ Time Frame: 5 years and indefinitely if possible ]Subjects on study will have tapering of the immunosuppressive medication and withdrawal of the immunosuppressive medication if withdrawal criteria are met.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165762
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792-1690|
|Principal Investigator:||Stephan Busque, MD,MS||Stanford University|