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

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.

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