Recruiting
Phase 1

Stem Transplantation

Sponsor:

Stephan Busque

Code:

NCT03591302

Conditions

Immune Tolerance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hematopoietic cell transplantation

Total Lymphoid irradiation

Study Details

Brief summary:

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Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Conditions

Immune Tolerance

Study ID

NCT03591302

Start date

Feb 2, 2024

Status verified date

Jun, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immune tolerance, Kidney transplantation

Intervention: HLA matched living donor recipients of a functioning kidney transplant graft at one year will receive hematopoietic cell transplantation and Total lymphoid irradiation. The intervention is intended to induce immune tolerance such as to allow withdrawal of the immunosuppressive drugs. Immune tolerance is achieved through the development of donor/recipient mixed chimerism following combined kidney and hematopoietic stem cell transplantation from the living donor.

Interventions

Hematopoietic cell transplantation

Transplantation of hematopoietic stem cells from living donor.

Total Lymphoid irradiation

Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.

Primary outcome measure

  • Percentage of patients no longer dependent on immunosuppressive drugs to maintain normal renal function. [ Time Frame: six months to up to five years post stem cell transplant ]

Central Contacts and Locations

Central contacts

Locations

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Everett Meyer, MD

More Information

Sponsor

Stephan Busque

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Kidney Transplantation
  • Blood Stem Cell Transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stephan Busque on 2026-07-01.