Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

Phase 1

Not yet recruiting

• Conditions: Liver Transplant; Complications; Liver Diseases
• Interventions: Drug: Autologous adipose derived mesenchymal stromal cells (AMSC)

• Registration Number: NCT06649864
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-18
• Study Start: 2026-02
• Primary Completion: 2028-01
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liver Transplant	Autologous adipose derived mesenchymal stromal cells (AMSC)	Subjects with liver disease with planned living donor liver transplantation

Primary Outcome Measures

Name	Time	Method
Side effects	24 months	Number of subjects to experience systemic symptoms, irritation, inflammation, infections or biliary obstructions

Secondary Outcome Measures

Name	Time	Method
Biliary complications	24 months	Number of subjects to develop biliary complications of strictures or leaks

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States