Trial Search Results

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

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injected after kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.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 If the stem cells persist in the recipient, immunosuppressive drugs will be gradually reduced until they are withdrawn completely at least six months after transplantation.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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Intervention(s):

  • Device: Immune tolerance

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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%

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Stephan Busque, MD
650-498-6189
Recruiting