DCreg in Living Donor Liver Transplantation

NCT ID: NCT03164265

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-30
• Study Completion Date: 2024-07-15

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.

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.

Conditions

Living Donor Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study arm

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

Group Type: EXPERIMENTAL

Regulatory Donor-Derived Dendritic Cell infusion

Intervention Type: BIOLOGICAL

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

Interventions

Regulatory Donor-Derived Dendritic Cell infusion

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

Intervention Type: BIOLOGICAL

Other Intervention Names

DCreg

Eligibility Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Angus W. Thomson PhD DSc

OTHER

Sponsor Role: lead

Responsible Party

Angus W. Thomson PhD DSc

Distinguished Professor of Surgery and Immunology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abhinav Humar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: recipient

View Document

Document Type: Informed Consent Form: donor

View Document

Other Identifiers

IND#17271

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY19020267

Identifier Type: -

Identifier Source: org_study_id