A Phase I Study of Autologous Adipose-derived Mesenchymal Stromal Cells in Preventing Biliary Complications After Living Donor Liver Transplant

Mayo Clinic2 sites in 1 country20 target enrollmentFebruary 1, 2027

InterventionsAutologous adipose derived mesenchymal stromal cells (AMSC)

DrugsAutologous adipose derived mesenchymal stromal cells (AMSC)

Overview

Phase: Phase 1
Intervention: Autologous adipose derived mesenchymal stromal cells (AMSC)
Conditions: Not specified
Sponsor: Mayo Clinic
Enrollment: 20
Locations: 2
Primary Endpoint: Side effects
Status: Not yet recruiting
Last Updated: 26 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety of autologous Adipose-Derived Mesenchymal Stem Cell for use in End-Stage Liver Disease patients undergoing the creation of a duct-to-duct anastomosis during Living Donor Liver Transplantation.

Registry

clinicaltrials.gov

Start Date

February 1, 2027

End Date

June 1, 2028

Last Updated

26 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Julie K. Heimbach

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Listed for liver transplantation
•Non-pediatric patients with a planned LDLT
•Ability to communicate with investigative staff
•Competence to give written informed consent
•Ability to comply with the entire study procedure
•All sexes and genders will be eligible for the study

Exclusion Criteria

•Planned deceased donor liver transplantation
•Uncontrolled / unresolved local or systemic infection
•Body mass index \> 40
•Planned pancreaticoduodenectomy or sleeve gastrectomy
•Anticipation of 3 biliary anastomoses (we will include those anticipated to have 1 or 2 biliary anastomoses as detailed below)
•Pregnancy or breastfeeding
•Non-liver cancers (we will include certain patients with primary liver cancer as detailed below)
•Treatment with any investigational drug / device within 60 days prior to study entry
•Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs
•Patients who are employees or relatives of the investigator