Not Yet RecruitingPhase 1

Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

United States20 participantsStarted 2027-02

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Side effects

Timeframe: 24 months

Trial details

NCT IDNCT06649864

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Jackie Reiter

507-538-2224 Reiter.Jacqulyn@mayo.edu

View on ClinicalTrials.gov More Liver Transplant; Complications trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.