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Could a stem cell transplant free kidney recipients from a lifetime of anti-rejection drugs?

NCT ID NCT03591302

Disease control Sponsor: Stephan Busque Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a stem cell transplant from the same donor can help people with a functioning kidney transplant stop taking immunosuppressive drugs. Participants receive total lymphoid irradiation and anti-thymocyte globulin to prepare their immune system, followed by an infusion of donor stem cells and T-cells. The goal is to see if the body can accept the kidney without long-term medication. The trial includes adults who have had a kidney transplant from a matched sibling donor for at least one year with no history of rejection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
donor hematopoietic stem cells and T-cells
What this could lead to
If successful, this could allow kidney transplant recipients to stop taking lifelong immunosuppressive drugs without rejecting their kidney.
What could go wrong
This is an early-phase trial with only 25 participants. The conditioning regimen carries risks of infection, graft failure, or rejection, and the approach may not work for everyone.

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 25 people

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

Started

Feb 2024

Expected to finish

Oct 2028

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 years and older

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: 1. All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection. 2. Patients who agree to participate in the study and sign an Informed Consent 3. The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent. 4. The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford. 5. Patients who have no known contraindication to the administration of rabbit ATG or radiation 6. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant. Exclusion Criteria: 1. Known allergy to 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 (HepBsAg+) or Hepatitis C infection. 5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (platelet count \< 100,000/mm3) 6. Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease. 7. Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease or interstitial fibrosis/Tubular Atrophy (IF/TA) score greater than 1.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune tolerance

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Stanford University Medical Center

    RECRUITING

    Palo Alto, California, 94304, United States

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