Could a bone marrow infusion help kidney transplant patients ditch lifelong pills?
NCT ID NCT04571203
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This phase 1 trial tests whether giving a bone marrow infusion along with a deceased donor kidney transplant can help the body accept the new kidney without needing lifelong anti-rejection drugs. The study enrolls adults with end-stage kidney disease who are already listed for a transplant. Participants receive a special conditioning regimen with low-dose radiation and an immune-suppressing drug to encourage the donor bone marrow cells to engraft and create immune tolerance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Combined deceased donor kidney and hematopoietic cell transplant with radiation and anti-thymocyte globulin (ATG)
- What this could lead to
- If successful, this approach could allow kidney transplant recipients to take fewer or no lifelong anti-rejection medications, improving quality of life.
- What could go wrong
- This is an early phase 1 study with only 30 participants, so results may not apply broadly. Risks include graft-versus-host disease, infections, and failure to achieve immune tolerance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: RECIPIENT INCLUSION CRITERIA: 1. Patient is ≥ 18 years old, and \<65 years of age. 2. Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care. 3. Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation. 4. A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR. 5. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant. 6. Females have a negative serum pregnancy test. 7. Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial. 8. No known contraindication to administration of rabbit ATG or low dose irradiation. DONOR INCLUSION CRITERIA: 1. Brain dead donor aged ≥ 16 and ≤ 55 2. Organ Procurement Organization (OPO) consent for vertebral body procurement 3. Organ Procurement Organization consent for research 4. Projected cold ischemia time \<24 hours. Exclusion Criteria: RECIPIENT EXCLUSION CRITERIA: 1. Known allergy to rabbit protein. 2. History of malignancy with the exception of non melanoma skin malignancy. 3. Pregnant woman or nursing mother. 4. Body weight \>90kg or BMI \>35. 5. Evidence of HIV 1/2 antibody (Ab), HTLV 1 and HTLV 2 Ab (Human T-Lymphotropic Virus), Hepatitis B sAg (surface antigen), Hepatitis C Ab, or positive syphilis screen. 6. EBV (Epstein Bar Virus)Ab positive donor to EBV Ab negative recipient. 7. Active bacterial, viral or fungal infection defined as currently taking medication for the infection. 8. Leukopenia (white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3). 9. Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk. 10. Concern for alcohol or other substance abuse. 11. Kidney disease at high risk for post transplant recurrence: aHUS (atypical hemolytic- uremic syndrome) and C3 glomerulopathy 12. Panel reactive antibody (PRA) \>80%. 13. Positive donor specific antibody (DSA). 14. Prior or combined organ transplant. 15. Patients with \>5 pack year smoking history, smoking within 10 years of enrollment, or first degree relative with lung cancer. DONOR EXCLUSION CRITERIA: 1. History of malignancy with the exception of non melanoma skin malignancy. 2. History of autoimmune disease. 3. Known medical diagnosis of Zika virus infection within the prior 6 months, including post mortem screening. 4. Serological evidence of HIV, Hepatitis B (surface antigen positive), or Hepatitis C infection. 5. Evidence of systemic infection. 6. Kidney Donor Profile Index (KDPI) \> 70%.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MSOB
RECRUITINGStanford, California, 94305, United States
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Stanford University
RECRUITINGPalo Alto, California, 94305, United States
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