Stem Cell Therapy for Liver Transplant Complications

Overseen By Jackie Reiter

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Investigational drugs

Disqualifiers: Infections, BMI > 40, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate during transplantation

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking any investigational drugs or using investigational devices, you must stop at least 60 days before joining the study.

Is stem cell therapy using adipose-derived mesenchymal stem cells safe for humans?

The research primarily involves animal studies, which suggest that adipose-derived mesenchymal stem cells (AD-MSCs) are generally safe and show potential in treating liver injuries in mice and rats. However, more human studies are needed to confirm their safety in people. ^{1 2 3 4 5}

How is the treatment using autologous adipose-derived mesenchymal stem cells different from other treatments for liver transplant complications?

This treatment is unique because it uses stem cells taken from the patient's own fat tissue, which reduces the risk of immune rejection. These cells can help repair liver damage by producing growth factors and cytokines (proteins that aid in healing) and by modulating the immune response, which is different from traditional treatments that may not address these aspects. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Autologous Adipose-Derived Mesenchymal Stem Cell for liver transplant complications?

Research shows that adipose-derived stem cells (ADSCs) can help repair liver damage in animal models, such as rats and mice, by promoting liver regeneration and reducing inflammation. These findings suggest that ADSCs might be beneficial for treating liver complications in humans as well. ^{1 2 3 8 9}

Who Is on the Research Team?

Julie Heimbach

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am on the liver transplant list.

I am mentally capable of understanding and signing the consent form.

My gender does not affect my eligibility for this study.

Exclusion Criteria

I am scheduled for surgery on my pancreas or stomach.

Body mass index > 40

Treatment with any investigational drug/device within 60 days prior to study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous Adipose-Derived Mesenchymal Stem Cells during Living Donor Liver Transplantation

Immediate during transplantation

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on biliary complications and side effects

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Adipose-Derived Mesenchymal Stem Cell

Trial Overview 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.

How Is the Trial Designed?

Group I: Liver Transplant Experimental Treatment 1 Intervention

Subjects with liver disease with planned living donor liver transplantation

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic potential and related signal pathway of adipose-derived stem cell transplantation for rat liver injury. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adipose derived mesenchymal stem cells efficiently rescue carbon tetrachloride-induced acute liver failure in mouse. [2022]

3. Singapore pubmed.ncbi.nlm.nih.gov

Effects of xenogeneic adipose-derived stem cell transplantation on acute-on-chronic liver failure. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Adipose tissue-derived mesenchymal stem cell transplantation promotes hepatic regeneration after hepatic ischemia-reperfusion and subsequent hepatectomy in rats. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Adipose-Derived Stem Cell Transplantation Attenuates Inflammation and Promotes Liver Regeneration after Ischemia-Reperfusion and Hemihepatectomy in Swine. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Adipose-derived mesenchymal stem cells slow disease progression of acute-on-chronic liver failure. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of adipose tissue-mesenchymal stem cell transplantation in rats with acetaminophen liver injury. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Cytokines in adipose-derived mesenchymal stem cells promote the healing of liver disease. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Efficacy of adipose tissue-derived mesenchymal stem cells for fulminant hepatitis in mice induced by concanavalin A. [2018]