What this study is
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.
What's being tested
- Autologous adipose derived mesenchymal stromal cells (AMSC)
Intervention · 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.
Study details
- Official title
- A Phase I Study of Autologous Adipose-derived Mesenchymal Stromal Cells in Preventing Biliary Complications After Living Donor Liver Transplant
- Sponsor
- Mayo Clinic
- Conditions
- Liver Transplant; Complications · Liver Diseases
- Enrolling
- 20 people
- Starts
- 2027-02
- Est. completion
- 2028-06
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
Study team
Sponsor
Mayo Clinic
Study ID 24-001649
Principal investigator
Julie Heimbach
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.