Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06649864

Enrollment

Registered

2024-10-21

Start date

2027-02-01

Completion date

2028-06-01

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases, Liver Transplant; Complications

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.

Interventions

DRUGAutologous 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTJackie Reiter

Reiter.Jacqulyn@mayo.edu507-538-2224

PRINCIPAL_INVESTIGATORJulie Heimbach

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026