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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStephan Busque

About this trial

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Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Eligibility criteria

Qualifiers

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.

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

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

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

Disqualifiers

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

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

Pregnant women or nursing mothers.

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

Trial design

Treatments tested in this trial

  • Hematopoietic cell transplantation
  • Total Lymphoid irradiation

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Stephan Busque

Lead sponsor

Stanford University

Sponsor institution