Kidney and Blood Stem Cell Transplantation That Eliminates Requirement for Immunosuppressive Drugs
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Immune Tolerance
In brief
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with lymphoid irradiation ,will change the immune system such that immunosuppressive drugs can be completely withdrawn.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 If the stem cells persist in the recipient, immunosuppressive drugs will be gradually reduced until they are withdrawn completely at least six months after transplantation.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.
Key facts
- Study ID
- NCT00319657
- Run by
- Stanford University
- People needed
- 15
- Starts
- 2004-07-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2021-06-18
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Kidney transplant performed at Stanford University Medical Center
- Have an HLA-matched sibling donor
- No known contraindication to administration of rabbit ATG or radiation
- Willing to use a reliable form of contraception for at least 24 months following transplantation
You may not qualify if…
- Previous treatment with rabbit ATG or a known allergy to rabbit proteins
- History of cancer, other than non-melanoma skin cancer
- Pregnant or breastfeeding
- HIV, Hepatitis B, or Hepatitis C infection
- Previous organ transplant
- Leukopenia (white blood cell count less than 3000/mm³)
- Thrombocytopenia (platelet count less than 100,000/mm³)
- cPRA>80%
Where it is running
- Stanford University, School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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