Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

March 31, 2026 updated by: Julie K. Heimbach, Mayo Clinic

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liver Transplant
Subjects with liver disease with planned living donor liver transplantation
Drug: Autologous adipose derived mesenchymal stromal cells (AMSC)
Adipose derived autologous mesenchymal stromal cells; [~500,000 cells/cm2] will be applied once to the biliary anastomosis using approximately 3-5 million cells in 5ml Lactated Ringer solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 24 months
Number of subjects to experience systemic symptoms, irritation, inflammation, infections or biliary obstructions
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biliary complications
Time Frame: 24 months
Number of subjects to develop biliary complications of strictures or leaks
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Julie Heimbach, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-001649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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