Recruiting

Amniotic Tissue for Biliary Outcomes in Living Donor Liver Transplant

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What is being tested

MiMedx AmnioFix

Biological
Who is being recruted

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorChoon Hyuck David Kwon
Study ContactErlind AllkushiMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 29, 2024

Actual date on which the first participant was enrolled.

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 grafts, specifically the MiMedx placental tissue grafts, can safely reduce complications related to bile ducts, which are crucial for liver function. Bile duct problems are a common issue after liver transplants, and finding a way to reduce these could significantly improve patient outcomes. This is important because it can enhance the healing process and overall success of liver transplants. Participants in this study undergo a liver transplant at the Cleveland Clinic as per standard procedures. During the surgery, a MiMedx placental tissue graft is placed around the bile duct connection. After the transplant, doctors regularly check the patients for a year to see if any bile duct complications arise. The study involves reviewing the participants’ medical records during follow-up visits to track progress and outcomes. This helps researchers understand the effectiveness of the grafts in preventing complications.

Official TitleBiliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
Principal SponsorChoon Hyuck David Kwon
Study ContactErlind AllkushiMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Adults >/= 18 years old

Recipient of LDLT

6 exclusion criteria prevent from participating
Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee.

Patients < 18 years old

Patients who cannot provide informed consent

Patients receiving deceased donor liver transplants, or who are not undergoing Liver transplant (LT)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

LDLT recipient with MiMedx placental graft placement

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Cleveland Clinic

Cleveland, United StatesOpen Cleveland Clinic in Google Maps
Recruiting
One Study Center