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Could a bone marrow infusion help kidney transplant patients ditch lifelong pills?

NCT ID NCT04571203

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • MSOB

    RECRUITING

    Stanford, California, 94305, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94305, United States

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