Stem Cell Therapy for Liver Transplant Complications
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety of a special type of stem cell therapy for individuals with severe liver disease undergoing a liver transplant from a living donor. The goal is to determine if these stem cells, derived from a person's own fat (autologous adipose-derived mesenchymal stem cells), can enhance the surgery process and recovery. This study targets individuals scheduled for a living donor liver transplant who do not have other major health issues, such as active infections or very high body weight. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
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 there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that using a person's own fat-derived stem cells may improve liver health. These cells can reduce liver scars and help restore liver function. However, some clinical trials have reported side effects, with blood clots and liver scarring being the most common.
As this trial is in its early stages, it primarily focuses on safety. Researchers are still learning how well patients tolerate the treatment. Prospective participants should understand these possible risks.12345Why do researchers think this study treatment might be promising?
Researchers are excited about using autologous adipose-derived mesenchymal stem cells for liver transplant complications because these stem cells have the unique ability to repair and regenerate damaged liver tissues. Unlike traditional immunosuppressive drugs and supportive care, which primarily manage symptoms and prevent rejection, these stem cells work by promoting healing directly at the cellular level. This approach not only has the potential to improve liver function more effectively but may also reduce the need for long-term medication, minimizing side effects and enhancing overall recovery.
What evidence suggests that this treatment might be an effective treatment for liver transplant complications?
Research has shown that certain stem cells, such as those from fat tissue, may help treat liver issues. Studies have found that these stem cells can improve liver health, reduce scarring, and enhance liver function. A review of several studies found that stem cell therapy can significantly increase survival rates and improve outcomes for people with liver failure. Early research also suggests that similar treatments have helped improve liver function in people with liver cirrhosis, which involves scarring of the liver. This trial will investigate the use of autologous adipose-derived mesenchymal stem cells in liver transplant patients, aiming to potentially reduce complications and improve liver health.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive autologous Adipose-Derived Mesenchymal Stem Cells during Living Donor Liver Transplantation
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on biliary complications and side effects
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Adipose-Derived Mesenchymal Stem Cell
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor