Could a single infusion of 'Trainer' cells free liver transplant patients from lifelong drugs?

NCT ID NCT04208919

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether a single infusion of donor-derived regulatory dendritic cells (DCreg) can help living donor liver transplant recipients safely stop taking immunosuppression drugs. Participants are low-risk patients who are 1 to 3 years post-transplant. They receive the DCreg infusion and then slowly wean off their anti-rejection medication, with close monitoring for rejection and other complications.

What this could mean

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

Active substance
donor-derived regulatory dendritic cells (DCreg)
What this could lead to
If successful, this approach could allow liver transplant recipients to stop taking lifelong immunosuppression drugs without rejecting the new liver.
What could go wrong
This is an early-phase trial with only 16 participants, so results may not apply broadly. There are risks of severe infusion reactions, infections, rejection, or graft loss.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

16 people

The number who actually took part.

Started

Dec 2019

Finished

Dec 2025

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: Donor 1. Able to understand and provide informed consent 2. Male or female age 18 or older at the time of enrollment 3. Have no contraindication to leukapheresis 4. For females of childbearing potential, a negative urine or serum pregnancy test 5. No live vaccines within 12 weeks prior to leukapheresis 6. Negative health history for risk factors related to Creutzfeldt-Jakob disease 7. Negative for West Nile Virus(a) 8. Negative for HIV (5th generation Test and NAT), HTLV-1, HTLV-2;(a) 9. Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and NAT)(a) 1. does not preclude donors from undergoing leukapheresis but cells may not be infused into recipient. Recipients 1. Low risk LDLT recipients, irrespective of gender, race, or ethnic background. Low risk is defined by absence of exclusion criteria (below). 2. Age 18 or older at the time of enrollment 3. Underwent de novo (first) liver transplant 1 to 3 years prior to enrollment 4. Female subjects of childbearing potential must have a negative pregnancy test upon study entry. 5. Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used from the time that study treatment begins until 1 year after completion of immunosuppression withdrawal. Exclusion Criteria: Recipients 1. History of positive crossmatch (performed prior to transplant) 2. Clinically treated rejection episode within 2 years prior to enrollment 3. Non-permissive LFTs within past 1 month 4. Repeat liver transplant 5. Prior other solid organ transplant 6. Significant co-morbid conditions such as severe heart or lung disease 7. Following etiology of liver disease: Primary Sclerosing Cholangitis (PSC), autoimmune, Primary Biliary Cirrhosis (PBC) 8. If prior history of Hepatitis B or C (HBV or HCV) infection, Hepatitis B or C Virus (HBV or HCV) viral load positive at the time of enrollment (successfully treated HBV or HCV patients are not excluded) 9. Positive antigen-antibody immunoassay for HIV-1/2 10. Any prior biopsy showing significant fibrosis or ductopenia. 11. Any medical condition that the investigator deems incompatible with participation in the trial.

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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.

Contacts and locations

Locations

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

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