Could a single infusion of 'Trainer' cells free liver transplant patients from lifelong drugs?
NCT ID NCT04208919
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
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Dec 2019
- Finished
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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
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18 years and older
- Sex
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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 Hide 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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Other studies related to the condition(s) this trial covers.
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