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Could a stem cell infusion free kidney transplant patients from lifelong drugs?

NCT ID NCT03943238

Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a special treatment before a kidney transplant can help the body accept the new organ without needing lifelong anti-rejection drugs. Participants receive radiation and immune-suppressing drugs, followed by an infusion of donor stem cells and the patient's own regulatory immune cells (Tregs). The goal is to see if this allows patients to safely stop taking anti-rejection medication after 18 months. The trial involves adults aged 18 to 65 receiving a kidney from a living donor.

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 recipient regulatory T cells (Tregs)
What this could lead to
If successful, this approach could allow kidney transplant recipients to stop taking lifelong anti-rejection drugs, reducing side effects and improving quality of life.
What could go wrong
This is an early-phase trial with a small number of participants. The regimen involves radiation and immune-suppressing drugs, which carry risks of infection and other complications. It 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 22 people

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

Started

Feb 2020

Expected to finish

Dec 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: 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.

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

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

Living donor kidney transplantation

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

  • Nothwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94305, United States

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