Phase 2
N=16
DCreg in Living Donor Liver Transplantation
Living Donor Liver Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT03164265 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Proportion of Safety Events — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Regulatory Donor-Derived Dendritic Cell infusion (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Angus W. Thomson PhD DSc
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Safety Events |
1 | — |
| PRIMARY Preliminary Efficacy |
3 | — |
| SECONDARY Donor Specific Antigen (DSA) Levels |
3; 7; 3 | — |
| SECONDARY Change in Renal Function |
4.42 | — |
| SECONDARY Change in Quality of Life |
-7.7; -12.5; -10; -3.83; -12.4; -13.75 | — |
| SECONDARY Change in Cardiovascular Risk Factors (Systolic Blood Pressure) |
10.5 | — |
| SECONDARY Change in Cardiovascular Risk Factors (Triglycerides) |
98.88 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
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;(*)
- 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.
Data sourced from ClinicalTrials.gov (NCT03164265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.