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Could a cell infusion free liver transplant patients from lifelong drugs?

NCT ID NCT03164265

Disease control Sponsor: Angus W. Thomson PhD DSc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether an infusion of special immune cells (regulatory dendritic cells) from the donor could help liver transplant recipients safely reduce their anti-rejection medications. Sixteen low-risk patients received the cell infusion a week before transplant, then followed a gradual drug-weaning schedule over a year. The goal was to see if some patients could achieve 'operational tolerance'—meaning their body accepts the new liver without needing long-term immunosuppression.

What this could mean

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

Active substance
Regulatory donor-derived dendritic cells (DCreg)
What this could lead to
If successful, this could allow some liver transplant recipients to reduce or stop taking lifelong anti-rejection drugs, improving quality of life and reducing side effects.
What could go wrong
This is an early-phase study with only 16 participants, so results may not apply broadly. There is a risk of organ rejection or serious infection if immunosuppression is reduced too much.

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

Aug 2017

Finished

Jul 2024

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 75 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: Donors 1. Able to understand and provide informed consent; 2. Male or female between the ages of 18-55; 3. Meet all standard institutional and UNOS criteria for liver donation; 4. For females of childbearing potential, a negative urine or serum pregnancy test; 5. Negative for HIV (5th generation Test and NAT), HTLV-1, HTLV-2;(\*) 6. Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and NAT)(\*) Recipients 1. Low risk recipient approved for LDLT, irrespective of gender, race, or ethnic background. Low risk is defined by absence of exclusion criteria (below). 2. Between ages 18 and 75 years 3. Undergoing de novo (first) liver transplant 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. (\*)does not preclude donors from undergoing leukapheresis but cells may not be infused into recipient.

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Conditions

The condition(s) this trial relates to.

chronic liver failure

As listed by the trial registrant

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

Living donor liver transplantation

Contacts and locations

Locations

  • UPMC

    Pittsburgh, Pennsylvania, 15261, United States

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