Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

ConditionsLiver Transplant; Complications Liver Diseases

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Listed for liver transplantation

Non-pediatric patients with a planned LDLT

Ability to communicate with investigative staff

Competence to give written informed consent

Disqualifiers

Planned deceased donor liver transplantation

Uncontrolled / unresolved local or systemic infection

Body mass index > 40

Planned pancreaticoduodenectomy or sleeve gastrectomy

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Liver TransplantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Side effects

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

Time frame

24 months

Secondary outcomes

Biliary complications

Number of subjects to develop biliary complications of strictures or leaks

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: