Liver Transplant; ComplicationsPhase 1NCT06649864
Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications
A Phase 1 study testing Autologous adipose derived mesenchymal stromal cells (AMSC) in people with Liver Transplant; Complications and Liver Diseases, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant; Complications, Liver Diseases
- What is being tested?
- Autologous adipose derived mesenchymal stromal cells (AMSC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Phase I Study of Autologous Adipose-derived Mesenchymal Stromal Cells in Preventing Biliary Complications After Living Donor Liver Transplant
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.
- Conditions
- Liver Transplant; Complications, Liver Diseases
- Being tested
- Autologous adipose derived mesenchymal stromal cells (AMSC)
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant | Experimental | Subjects with liver disease with planned living donor liver transplantation Receives: Drug: Autologous adipose derived mesenchymal stromal cells (AMSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects
Number of subjects to experience systemic symptoms, irritation, inflammation, infections or biliary obstructions
Measured: 24 months
Secondary outcomes (1)
Biliary complications
Number of subjects to develop biliary complications of strictures or leaks
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study startFeb 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie K. Heimbach, Mayo Clinic
- Investigators
- Julie Heimbach, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649864
- Sponsor's protocol ID
- 24-001649
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Autologous Adipose-derived Mesenchymal Stromal Cells in Preventing Biliary Complications After Living Donor Liver Transplant
- ClinicalTrials.gov ID
- NCT06649864
- Acronym / sponsor ID
- 24-001649
- Conditions
- Liver Transplant; Complications, Liver Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant | Experimental | Drug: Autologous adipose derived mesenchymal stromal cells (AMSC)Subjects with liver disease with planned living donor liver transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Liver Transplant |
Primary outcome
Side effects
Time frame: 24 months
Number of subjects to experience systemic symptoms, irritation, inflammation, infections or biliary obstructions
1 secondary outcome
Biliary complications
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Heimbach principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous adipose derived mesenchymal stromal cells (AMSC) in people with Liver Transplant; Complications and Liver Diseases, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jackie Reiter (507-538-2224, Reiter.Jacqulyn@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.