New approach to kidney transplantation using donor stem cells and regulatory T cells
Official title: Phase 1 Study of Total Lymphoid Irradiation, Total Body Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+, T-cell and Recipient T Regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation
Run by Stanford University · NCT03943238 · Data updated 2026-11-12
This study is testing a new treatment for people getting a kidney transplant that uses donor stem cells and special immune cells to see if it can help them avoid taking lifelong anti-rejection medication.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Palo Alto, California and 1 other locations) |
| Status | Recruiting |
| Started | February 1, 2020 |
| Main results expected | November 1, 2029 |
| Study ends | December 1, 2029 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT03943238 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 65 who are receiving a living donor kidney transplant and have a haplotype-matched donor.
✕Probably not a fit
Patients with a history of malignancy (except non-melanoma skin cancers), those with certain viral infections, or those who have previously received rabbit ATG may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate a preparatory regimen involving total lymphoid irradiation (TLI), total body irradiation (TBI), and anti-thymocyte globulin (ATG) in conjunction with the infusion of donor hematopoietic stem cells and recipient regulatory T cells (Tregs) for living donor kidney transplant recipients. The goal is to achieve mixed chimerism, which may allow for the eventual withdrawal of immunosuppressive drugs post-transplant. Participants will undergo a series of treatments and monitoring to assess the development of chimerism and the feasibility of stopping immunosuppressive therapy. This innovative approach seeks to enhance graft tolerance and improve long-term outcomes for kidney transplant recipients.
Why it matters
Potential benefit: If successful, this approach could eliminate the need for lifelong immunosuppressive medications in kidney transplant recipients.
How similar studies have gone: While the approach of using donor stem cells and Tregs is innovative, similar studies have shown promise in achieving graft tolerance, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Stanford University
Palo Alto, California, United States Recruiting -
Nothwestern University
Chicago, Illinois, United States Recruiting
Study contacts
- Study coordinator: Kevin Ly, BS
- Email: kevinly@stanford.edu
- Phone: 650-497-6057
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.