Transplanting stem cells and kidneys from the same donor to prevent rejection
Official title: Phase 1b/2a Trial of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) From an HLA-partially Matched Related or Unrelated Donor After TCRαβ+ T-cell/CD19+ B-cell Depletion for Patients Who Will Receive a Kidney Transplant (KT) From the Same HSCT/KT Donor
Run by Stanford University · NCT05508009 · Data updated 2026-11-12
This study is testing if giving patients stem cells and a kidney from the same donor can help prevent kidney rejection without needing lifelong medication to suppress their immune system.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 30 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Status | Recruiting |
| Started | January 10, 2023 |
| Main results expected | October 2032 |
| Study ends | October 2034 |
| Registry record updated | July 17, 2023 |
| Trial ID | NCT05508009 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with specific genetic or immunologic diseases requiring a kidney transplant and who have a matched donor.
✕Probably not a fit
Patients who do not have a suitable matched donor or those with conditions not listed in the eligibility criteria 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 trial investigates the sequential transplantation of αβdepleted hematopoietic stem cells followed by kidney transplantation in patients who require a kidney transplant. The goal is to prevent kidney rejection without the need for lifelong immunosuppression, thereby reducing the risk of chronic rejection and the necessity for repeated transplants. The study is non-randomized and open-label, focusing on patients with specific genetic and immunologic conditions leading to kidney failure. It involves administering a combination of chemotherapy and radiation to prepare patients for the transplant.
Why it matters
Potential benefit: If successful, this approach could eliminate the need for lifelong immunosuppression in kidney transplant recipients.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in reducing rejection rates in transplant patients, though this specific methodology is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Anticipated need for kidney transplant due to: a. Underlying genetic/immunologic disease the following conditions i. SIOD ii. FSGS iii. Cystinosis iv. SLE v. Membranoproliferative glomerulonephritis vi. Renal vasculitis characterized by positivity of the presence of ANCA vii. Other genetic diseases leading to kidney disease requiring KT Or b. Patients who have rejected a previous KT regardless of the underlying disease * Chronic kidney disease (CKD) stage 3 or greater * Steroids \< 0.5 mg/Kg/day * The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DQB1 and HLA-DRB1 * Lansky/Karnofsky score \> 50; the Karnofsky Scale will be used in subjects ≥ 16 years of age, and the Lansky Scale will be used for those \< 16 years of age. * Able to give informed consent or have an LAR available to provide consent * Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any cGvHD Exclusion Criteria: * Pregnant or lactating females. * Greater than Grade II aGvHD or severe, unmanaged extensive cGvHD due to a previous allograft at the time of inclusion * Dysfunction of liver (ALT/AST \> 10 times upper normal value, or direct bilirubin \> 3 times upper normal value), unmanageable dysfunction of renal function while undergoing dialysis * Severe cardiovascular disease at the time of evaluation unresponsive to nutritional and dialytic support (left ventricular ejection fraction \< 40%), or clinical or echocardiographic evidence of severe diastolic dysfunction * Current active infectious disease. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load. * Serious concurrent uncontrolled medical disorders except for primary disease leading to chronic kidney disease * Lack of patient/parent/guardian informed consent * Any severe concurrent disease which, in the judgement of the investigator would place the patient at increased risk during participation in the study
Where it's running
-
Lucile Packard Children's Hospital
Palo Alto, California, United States Recruiting
Study contacts
- Principal investigator: Alice Bertaina, MD — Stanford University
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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.