A Phase I Study of Autologous Adipose-derived Mesenchymal Stromal Cells in Preventing Biliary Complications After Living Donor Liver Transplant
Mayo Clinic
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 bil…
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.
Location
- Mayo Clinic in RochesterRochester, Minnesota