Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

Mayo Clinic

Status and phase

Not yet enrolling

Phase 1

Conditions

Liver Transplant; Complications

Liver Diseases

Treatments

Drug: Autologous adipose derived mesenchymal stromal cells (AMSC)

Study type

Interventional

Funder types

Other

Identifiers

NCT06649864

24-001649

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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