Adipose-Derived Mesenchymal Stem Cell for Preventing Bili... | NCT06649864

Studies
Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

NCT06649864

Sponsor

Mayo Clinic

Status

Not yet recruiting

Last Update Posted

Apr 6, 2026Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Liver Transplant; Complications
Liver Diseases

Interventions

Autologous adipose derived mesenchymal stromal cells (AMSC)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2027Estimated

Primary Completion Date

Jan 2028Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Oct 17, 2024

First Submission Date that Met QC Criteria

Oct 17, 2024

First Posted Date

Oct 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver Transplant	Experimental	Subjects with liver disease with planned living donor liver transplantation	Drug: Autologous adipose derived mesenchymal stromal cells (AMSC)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Side effects	Number of subjects to experience systemic symptoms, irritation, inflammation, infections or biliary obstructions	24 months

Secondary Outcomes

Measure	Description	Time Frame
Biliary complications	Number of subjects to develop biliary complications of strictures or leaks	24 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jackie Reiter	Contact	507-538-2224		Reiter.Jacqulyn@mayo.edu

Overall Officials

Name	Affiliation	Role
Julie Heimbach	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided