Trial Search Results

Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.

The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stephan Busque

Intervention(s):

  • Biological: Hematopoietic cell transplantation
  • Radiation: Total Lymphoid irradiation

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   1. All consenting adults of age 18 years and older with previous HLA matched sibling
   living donor renal transplants who still have their HLA- matched kidney donor
   available, and who have no history of acute or chronic rejection.

   2. Patients who agree to participate in the study and sign an Informed Consent

   3. The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell
   donation, agrees to participate and has signed an Informed Consent.

   4. The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the
   histocompatibility laboratory at Stanford.

   5. Patients who have no known contraindication to the administration of rabbit ATG or
   radiation

   6. Males and females of reproductive potential who agree to practice a reliable form of
   contraception for at least 18 months post transplant.

Exclusion Criteria:

   1. Known allergy to ATG or a known allergy to rabbit proteins.

   2. History of malignancy with the exception of non-melanoma skin malignancies.

   3. Pregnant women or nursing mothers.

   4. Serological evidence of HIV, Hepatitis B (HepBsAg+) or Hepatitis C infection.

   5. Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (platelet
   count < 100,000/mm3)

   6. Previous history of acute or chronic rejection of the kidney transplant or recurrence
   of the original disease.

   7. Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of
   original disease or interstitial fibrosis/Tubular Atrophy (IF/TA) score greater than
   1.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting