Recruiting
Phase 1

TLI, TBI, ATG & HSCT

Sponsor:

Stanford University

Code:

NCT03943238

Conditions

Living Donor Kidney Transplantation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs

Study Details

Brief summary:

This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.

Conditions

Living Donor Kidney Transplantation

Study ID

NCT03943238

Start date

Feb 1, 2020

Status verified date

Jun, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Nov 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.
2. Patients who agree to participate in the study and sign an Informed Consent.
3. Patients who have no known contraindication to administration of rabbit ATG or radiation.
4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant

Exclusion Criteria:

1. Previous treatment with rabbit 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 surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.
5. Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3).
6. Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and/or current donor specific antibody (DSA)
7. Prior organ transplantation
8. High risk of primary kidney disease recurrence
9. Advanced coronary or vascular disease.

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combined kidney/stem cell transplants and recipient's Tregs

Preparatory regimen including TLI, TBI, ATG after kidney transplantation followed by infusion of donor CD34+, T cell and recipient Tregs

Interventions

Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs

Living donor kidney transplant recipients will receive after a preparatory regimen of total lymphoid irradiation, total body irradiation and anti-thymocyte globulin an infusion of purified donor CD34+ of >10 x10\^6 cells /Kg, 100 x 10\^6 donor T cell/ Kg and and an escalated dose of recipient Tregs starting at 25 x10\^6/Kg.

Primary outcome measure

  • Count of participants with sustained mixed chimerism of >25% at 18 months [ Time Frame: Month 18 ]
  • Count of participants able to withdraw from immunosuppressive drugs without evidence of rejection at 18 months [ Time Frame: Month 18 ]

Central Contacts and Locations

Central contacts

Kevin Ly, BS

650-497-6057kevinly@stanford.edu

Stephan Busque, MD

650-498-6189sbusque@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Renata Gilfanova

650-736-0245Rgilfan@stanford.edu

Stephan Busque, MD

650-498-6189sbusque@stanford.edu

Principal Investigator:

Everett Meyer, MD

Nothwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Leah Goudy, RN

312-694-0242leah.goudy@northwestern.edu

Joseph Leventhal, MD

312-695-8900jleventh@nm.org

Principal Investigator:

Joseph Leventhal, MD

More Information

Sponsor

Stanford University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • kidney transplant
  • Immunological Tolerance
  • Tregs
  • Stem cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-07-01.