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

Not Recruiting

Trial ID: NCT03591302


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Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Official Title

Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion to Withdraw Immunosuppressive Drugs From Recipients of a Previous HLA Matched Living Donor Kidney Transplantation .

Stanford Investigator(s)

John Scandling
John Scandling

Professor of Medicine (Nephrology) at the Stanford University Medical Center, Emeritus

Stephan Busque
Stephan Busque

Professor of Surgery (Abdominal Transplantation)

Everett Meyer
Everett Meyer

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), of Pediatrics (Stem Cell Transplantation) and, by courtesy, of Surgery (Abdominal Transplantation)

Khoa Thomas Pham
Khoa Thomas Pham

Clinical Associate Professor, Surgery - Abdominal Transplantation

Colin Lenihan
Colin Lenihan

Clinical Associate Professor, Medicine - Nephrology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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

   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


biological: Hematopoietic cell transplantation

radiation: Total Lymphoid irradiation

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305