Menu
Not yet recruiting NCT06649864

Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

Phase I Interventional Liver Transplant; Complications Liver Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous adipose derived mesenchymal stromal cells (AMSC).
Who it may be relevant to
Registry conditions: Liver Transplant; Complications, Liver Diseases. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Autologous 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.

Primary outcome measures

  • Side effects [Time frame: 24 months]
Secondary outcome measures (1)
  • Biliary complications [Time frame: 24 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06649864 · 24-001649

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗