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

Liver Transplant

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 Allkushi
Last updated: August 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 29, 2024Actual 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 Allkushi
Last updated: August 3, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Liver Transplant
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

Biliary complications will be defined as any confirmed leakage of bile into the peritoneal cavity outside of the ductal system or biliary stricture.
Secondary Objectives

Rates of postoperative complications and outcomes including: Re-operation, acute or chronic graft rejection, procedural intervention (in total and biliary in nature), delayed graft function, primary graft non-function, surgical site infection

Hospital length of stay

ICU length of stay (days)

Number of readmissions post-operatively

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 ClinicCleveland, United StatesSee the location
Recruiting
One Study Center