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Living Donor Liver TransplantationPhase 1/2NCT03164265

DCreg in Living Donor Liver Transplantation

A Phase 1/2 study testing Regulatory Donor-Derived Dendritic Cell infusion in people with Living Donor Liver Transplantation, run by Angus W. Thomson PhD DSc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived DCreg 1 week prior to transplantation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Living Donor Liver Transplantation
What is being tested?
Regulatory Donor-Derived Dendritic Cell infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
30 Aug 2017to 15 Jul 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Donors
  • Able to understand and provide informed consent;
  • Male or female between the ages of 18-55;
  • Meet all standard institutional and UNOS criteria for liver donation;
  • For females of childbearing potential, a negative urine or serum pregnancy test;
  • Negative for HIV (5th generation Test and NAT), HTLV-1, HTLV-2;(*)
Show all 14Show fewer
  • Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and NAT)(*)
  • Recipients
  • Low risk recipient approved for LDLT, irrespective of gender, race, or ethnic background. Low risk is defined by absence of exclusion criteria (below).
  • Between ages 18 and 75 years
  • Undergoing de novo (first) liver transplant
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry.
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC

    Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

Official title: Safety and Preliminary Efficacy of Donor-derived Regulatory Dendritic Cell (DCreg) Infusion and Immunosuppression Withdrawal in Living Donor Liver Transplantation

Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived DCreg 1 week prior to transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6 months after transplantation. At that time point, recipients meeting specific criteria will be slowly weaned off MPA per standard of care over a period of 6 months. Participants will then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet specific criteria be weaned off Tac over 6 months . Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression.

Read the detailed description

Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived DCreg with concurrent mycophenolic acid (MPA) therapy (1/2 dose) 1 week prior to transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6 months after transplantation. At that time point, recipients meeting specific criteria (no rejection and permissive liver function tests (LFTs)) will be slowly weaned off MPA per standard of care over a period of 6 months. Participants will then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet the criteria of no rejection and permissive LFTs will undergo a protocol liver biopsy and proceed to Tac weaning over 6 months if liver biopsy is permissive. Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression. They will undergo a liver biopsy at 1 yr and 3 yrs after immunosuppression withdrawal. Participants who are removed from the study protocol at any time will return to standard of care but will continue to be followed by the study team and may undergo a liver biopsy at the end of the study (4.5 yrs after transplantation). For subjects who return to standard of care (on immunosuppression at end of study), the year 4.5 biopsy will be optional.

Being tested
Regulatory Donor-Derived Dendritic Cell infusion
Keywords
Regulatory Dendritic Cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regulatory Donor-Derived Dendritic Cell infusionBiological

    Also called DCreg

    Regulatory dendritic cells that were prepared from a donor leukapheresis will be infused into liver transplant recipients 7 days prior to surgery

Study groups in NCT03164265
Study groupRoleWhat they receive
Study armExperimentalLiving donor liver transplant recipients receiving donor-derived DCreg infusion. This is a single arm study
Receives: Biological: Regulatory Donor-Derived Dendritic Cell infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Safety Events

    1. Safety: Safety will be determined by assessing the percentage of subjects experiencing the following events: i) CTCAE Grade 4 or higher infusion reaction; ii) CTCAE Grade 4 or higher infection; iii) Malignancy other than non-melanoma skin cancer or HCC recurrence; iv) Rejection resulting in recipient death or retransplantation; v) Biopsy-proven severe acute rejection; vi) Any grade chronic rejection; vii) Non-surgical graft loss; viii) Recipient death;

    Measured: 6 years

  2. Preliminary Efficacy

    Proportion of patients able to achieve staged immunosuppression withdrawal with operational tolerance

    Measured: 2.5 years

Secondary outcomes (5)

  1. Donor Specific Antigen (DSA) Levels

    DSA levels early (<6 weeks) and late (> 6 weeks) after transplantation

    Measured: 6 years

  2. Change in Renal Function

    Change in renal function measured by change in estimated glomerular filtration rate (eGFR)

    Measured: from baseline to 4.5 years post transplantation

  3. Change in Quality of Life

    Scale title: Short Form 36 (SF-36) Quality of Life questionnaire. Minimum and maximum values 0 to 100 higher scores indicates better health.

    Measured: 1 year post-transplantation (prior to weaning) 4.5 years post transplantation

  4. Change in Cardiovascular Risk Factors (Systolic Blood Pressure)

    Measured: from baseline to 4.5 years post transplantation

  5. Change in Cardiovascular Risk Factors (Triglycerides)

    Measured: from baseline to 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2017
  2. Study start30 Aug 2017
  3. Primary completion15 Jul 2024
  4. Study completion15 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03164265
Sponsor's protocol ID
STUDY19020267
Other IDs
IND#17271
Status last verified
Aug 2025
First submitted
10 May 2017
Last updated
16 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Humar A, Hadjiyannis Y, Macedo C, Tran LM, Elinoff BD, Hughes CB, Ganesh SR, Zahorchak AF, Ables EM, Styn MA, Landsittel D, Zeevi A, Lakkis FG, Metes DM, Thomson AW. Donor-derived regulatory dendritic cell infusion and early immunosuppressive drug withdrawal in living-donor liver transplantation: a phase I/IIa trial. Nat Commun. 2026 Apr 17;17(1):3226. doi: 10.1038/s41467-026-71280-8.

    PubMed 41997912

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Regulatory Donor-Derived Dendritic Cell infusion in people with Living Donor Liver Transplantation, run by Angus W. Thomson PhD DSc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Safety Events (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03164265, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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