Characterizing Treg and T Cell Subsets in Liver Transplant Recipients With Operational Tolerance.

Overview

About this study

The purpose of this study is to determine if specific immune signatures, indicative of a balanced immune response and graft acceptance, will distinguish tolerant patients from those requiring ongoing immunosuppressive therapy. Also, to uncover a deeper understanding if the molecular and immunological mechanisms associated with operational tolerance will uncover novel targets for therapeutic interventions, ultimately paving the way for personalized and minimally immunosuppressed liver transplant approaches.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult patients (age ≥ 18 years old) undergoing liver biopsy as part of their clinical care.
  • Participants who are at least three years post-liver transplantation to allow for stabilization of graft function.
    • Patients with a documented history of immunosuppressive medication usage post-transplant; and/or
    • Patients who have been successfully withdrawn from immunosuppressive medication.
  • Individuals with stable graft function, as evidenced by regular liver function tests within the normal range for at least six months.

Exclusion Criteria: 

  • Individuals with active infections that may influence immune status.
  • Patients with a history of multiple organ transplants to ensure a focus on liver-specific tolerance mechanisms.
  • Individuals with significant comorbidities that may impact immune function or complicate the assessment of operational tolerance.
  • Pregnant or breastfeeding individuals
  • Patients with a history of malignancy within the last five years.
    1. Except for any patient with non-melanoma skin cancer that was fully resected and not on systemic therapy may be included
  • Individuals unable or unwilling to comply with study follow-up requirements.
  • Individuals whose etiology of liver disease was PBC, PSC, AIH
  •  At least 2 episodes of acute cellular rejection at any time; at least one episode of moderate-severe rejection; any episode of antibody mediated rejection
  • Individuals having any biliary and/or vascular complications within the liver graft

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/06/2024. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohsen Khosravi Maharlooei, M.D.

Open for enrollment

Contact information:

Allyson Fultz

(480) 301-6198

Fultz.Allyson@mayo.edu

More information

Publications

Publications are currently not available