Amniotic Tissue for Liver Transplant

Overseen By Mary Bilancini

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Choon Hyuck David Kwon

Disqualifiers: Children, Cognitively-impaired, Pregnant, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of using placental tissue grafts in liver transplants from living donors, focusing on their impact on bile duct health. The treatment under study, MiMedx AmnioFix, uses amniotic tissue. Ideal candidates for this study are those who have had a living donor liver transplant. The trial aims to determine if this new approach can improve outcomes for liver transplant patients. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative liver transplant solutions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that placental tissue grafts are safe for liver transplant recipients?

Research has shown that MiMedx AmnioFix, a type of tissue graft from the placenta, has been studied for safety in medical treatments. In past studies, most patients experienced mild side effects, indicating they could tolerate it without major issues. MiMedx AmnioFix is a tissue allograft, using placenta tissue to aid healing. It has been used in various forms and is considered safe in many medical situations. While detailed information on side effects specifically for liver transplants isn't fully available, its progression to Phase 2 trials suggests confidence in its safety for further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard liver transplant procedures, which typically involve using only the donor's liver tissue, MiMedx AmnioFix introduces an innovative approach by incorporating placental tissue into the transplant process. This placental graft, derived from amniotic tissue, is believed to enhance healing and reduce inflammation. Researchers are excited about this treatment because it has the potential to improve the success rate of liver transplants by promoting better integration and function of the transplanted liver, potentially leading to faster recovery and fewer complications for recipients.

What evidence suggests that MiMedx AmnioFix might be an effective treatment for liver transplant?

Research has shown that MiMedx AmnioFix, a tissue graft made from amniotic material, can improve surgical outcomes. In this trial, participants undergoing a Living Donor Liver Transplant (LDLT) will receive the MiMedx placental graft. Studies with similar placental tissue grafts have been very successful, particularly in reducing post-surgical complications. Among these products, MiMedx has the most extensive and reliable evidence, demonstrating clear positive results. This suggests that using AmnioFix in liver transplants might enhance bile flow, a digestive fluid. Overall, the evidence supports the potential effectiveness of this treatment in liver transplants. ^{1 2 3 5 6}

Who Is on the Research Team?

Choon Hyuck D Kwon, MD, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults who are undergoing a living donor liver transplant. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

I have received a living donor liver transplant.

I am 18 years old or older.

Exclusion Criteria

Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee

I do not want to participate in the trial.

I am unable to give informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplant Procedure

Participants undergo living donor liver transplant with MiMedx placental tissue graft placement

1 day

1 visit (in-person)

Post-operative Care

Participants are monitored for post-operative complications and outcomes, including ICU and hospital stay

Up to 365 days

Follow-up

Participants are monitored for biliary complications and other outcomes up to 1 year post-transplant

1 year

What Are the Treatments Tested in This Trial?

Interventions

• MiMedx AmnioFix

Trial Overview The study is testing the safety of using placental tissue grafts (MiMedx AmnioFix) during liver transplants. It's a pilot study, meaning it's an early-stage trial to gather preliminary data on how well these grafts might work in improving biliary outcomes.

How Is the Trial Designed?

Group I: Living Donor Liver Transplant (LDLT) graft recipient Experimental Treatment 1 Intervention

LDLT recipient with MiMedx placental graft placement

Who Is Running the Clinical Trial?

Choon Hyuck David Kwon

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07102550

Biliary Anastomosis in Living Donor Liver Transplant With ... What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting?

2. patlynk.com patlynk.com/trial/NCT07102550

Amniotic Tissue for Biliary Outcomes in Living Donor Liver ... This study focuses on using placental tissue grafts in adult patients who receive a liver transplant from a living donor. The main aim is to see if these ...

3. withpower.com withpower.com/trial/phase-2-transplantation-liver-9-2024-720d8

Amniotic Tissue for Liver Transplant Interventions. MiMedx AmnioFix. Trial Overview The study is testing the safety of using placental tissue grafts (MiMedx AmnioFix) during liver transplants.

4. mimedx.com mimedx.com/clinical-evidence/

Clinical Evidence MIMEDX has the largest body of Level I evidence among Placental Allograft products. Statistically significant results in randomized controlled trials.

5. docs.publicnow.com docs.publicnow.com/3E9F9F8E8DEF66F32409440FE734EF743F9EC3E5

mimedx The effectiveness of amniotic tissue as a therapy for any particular indication or condition; ... improve surgical outcomes ... AMNIOFIX in Liver. Transplant. RCT ...

6. mimedx.com mimedx.com/amniofix/

AMNIOFIX AMNIOFIX is a tissue allograft composed of dehydrated human amnion/chorion membrane (DHACM). It is available in sheet, fenestrated, and wrap configurations.