DCreg in Living Donor Liver Transplantation

NCT03164265 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: STUDY19020267IND#17271
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Living Donor Liver Transplantation

Keywords

Regulatory Dendritic Cells

Outcome Measures

Primary Outcomes (2)

• 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;

  6 years

• Preliminary Efficacy

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

  2.5 years

Secondary Outcomes (5)

• Donor Specific Antigen (DSA) Levels

  6 years

• Change in Renal Function

  from baseline to 4.5 years post transplantation

• Change in Quality of Life

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

• Change in Cardiovascular Risk Factors (Systolic Blood Pressure)

  from baseline to 4.5 years post transplantation

• Change in Cardiovascular Risk Factors (Triglycerides)

  from baseline to 4.5 years

Study Arms (1)

Study arm

EXPERIMENTAL

Living donor liver transplant recipients receiving donor-derived DCreg infusion. This is a single arm study

Biological: Regulatory Donor-Derived Dendritic Cell infusion

Interventions

Regulatory Donor-Derived Dendritic Cell infusion BIOLOGICAL

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

Also known as: DCreg

Study arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angus W. Thomson PhD DSc: lead
• University of Pittsburgh: collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15261, United States

Location

Results Point of Contact

• Title: Dr. Angus Thomson
• Organization: University of Pittsburgh

thomsonaw@upmc.edu

(412) 624-6392

Study Officials

• Abhinav Humar, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Distinguished Professor of Surgery and Immunology

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 23, 2017
• Study Start: August 30, 2017
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)