Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

NCT06649864 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 24-001649
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications; Liver Diseases

Outcome Measures

Primary Outcomes (1)

• Side effects

  Number of subjects to experience systemic symptoms, irritation, inflammation, infections or biliary obstructions

  24 months

Secondary Outcomes (1)

• Biliary complications

  24 months

Study Arms (1)

Liver Transplant

EXPERIMENTAL

Subjects with liver disease with planned living donor liver transplantation

Drug: Autologous adipose derived mesenchymal stromal cells (AMSC)

Interventions

Autologous adipose derived mesenchymal stromal cells (AMSC) DRUG

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.

Liver Transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Julie Heimbach

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Reiter

CONTACT

507-538-2224; Reiter.Jacqulyn@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)