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ACTIVE NOT RECRUITING
NCT00319657
PHASE1/PHASE2

Kidney and Blood Stem Cell Transplantation That Eliminates Requirement for Immunosuppressive Drugs

Sponsor: Stanford University

View on ClinicalTrials.gov

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 blood stem cells injected after kidney transplantation, in combination with lymphoid irradiation ,will change the immune system such that immunosuppressive drugs can be completely withdrawn. Patients must have a healthy, completely human leukocyte antigen (HLA)-matched brother or sister as the organ and stem cell donor. One to two months before kidney transplant surgery, blood stem cells will be removed from the donor and the cells will be frozen. After transplant surgery, the recipient will receive radiation and anti-T cell antibody treatments for two weeks to prepare for injection of the stem cells. The stem cells will be injected at the end of the two-week treatment. If the stem cells persist in the recipient, immunosuppressive drugs will be gradually reduced until they are withdrawn completely at least six months after transplantation. Patients will be followed in the Stanford clinics for transplant patients. Patients who live outside of the San Francisco Bay Area must remain near Stanford for six weeks after transplant surgery.

Official title: Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-Cell Transfusion in HLA-Matched Living Donor Kidney Transplantation

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2004-07

Completion Date

2026-07

Last Updated

2021-06-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

Hematopoietic cell transplantation

Transplantation of hematopoietic stem cells from the living donor.

RADIATION

Total lymphoid irradiation

Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.

Locations (1)

Stanford University, School of Medicine

Stanford, California, United States