Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications
NCT ID: NCT06649864
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2026-02-28
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Liver Transplant
Subjects with liver disease with planned living donor liver transplantation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Julie K. Heimbach
Principal Investigator
Principal Investigators
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Julie Heimbach
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Other Identifiers
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24-001649
Identifier Type: -
Identifier Source: org_study_id
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