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Stem Cell Therapy

Stem Cell Therapy for Liver Transplant Complications

Phase 1
Waitlist Available
Led By Julie Heimbach
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Listed for liver transplantation
Non-pediatric patients with a planned LDLT
Must not have
Planned pancreaticoduodenectomy or sleeve gastrectomy
Planned deceased donor liver transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to evaluate the safety of using a patient's own stem cells from fat tissue in liver disease patients undergoing a specific type of liver transplant surgery."

Who is the study for?
This trial is for adults listed for liver transplantation who can give informed consent and follow the study procedures. It's not for those with a BMI over 40, recent investigational drug/device use, multiple biliary anastomoses planned, non-liver cancers, uncontrolled infections, or expecting to receive a deceased donor liver transplant.
What is being tested?
The study tests the safety of using one's own fat-derived stem cells (AMSC) in patients with end-stage liver disease during live donor liver transplants to prevent bile duct complications.
What are the potential side effects?
Potential side effects may include typical risks associated with stem cell therapy such as immune reactions, infection at injection site, and possible interference with liver function or healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on the liver transplant list.
Select...
I am an adult scheduled for a living donor liver transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for surgery on my pancreas or stomach.
Select...
I am scheduled for a liver transplant from a deceased donor.
Select...
I am expected to undergo up to 3 bile duct connections.
Select...
I do not have any ongoing infections that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Side effects
Secondary study objectives
Biliary complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Liver TransplantExperimental Treatment1 Intervention
Subjects with liver disease with planned living donor liver transplantation

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,061,012 Total Patients Enrolled
Julie HeimbachPrincipal InvestigatorMayo Clinic
~13 spots leftby Jan 2027
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