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NCT Number: NCT06649864

Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

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.

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Key information

Conditions

Liver Transplant; Complications Digestive System Diseases Liver Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Side effects

    Time frame: 24 months

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

Secondary outcomes

  1. Biliary complications

    Time frame: 24 months

    Number of subjects to develop biliary complications of strictures or leaks

Study contacts

Contact information is provided by the study sponsor or research team.

Jackie Reiter

CONTACT

[email protected]

507-538-2224

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Phase I Study of Autologous Adipose-derived Mesenchymal Stromal Cells in Preventing Biliary Complications After Living Donor Liver Transplant

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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