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Living Donor Liver Transplant with Amniotic Tissue

This study is looking at whether using MiMedx AmnioFix, a special tissue graft made from placenta, can help reduce problems with bile ducts after a living donor liver transplant. The study will place MiMedx AmnioFix around the bile duct connection during your transplant. Researchers want to see if this helps prevent complications like bile leaks or blockages within one year after your transplant. You might be able to join if you are an adult (18 or older) who is having a living donor liver transplant. The study aims to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is a pilot study that is not randomized, meaning participants are not randomly assigned to different groups. It is a single-arm study, so all 40 participants will receive the MiMedx AmnioFix.
What's involved
You will undergo a living donor liver transplant as usual, and consent to having the MiMedx AmnioFix placed during the surgery. The study team will review your medical records after your regular follow-up visits for up to one year after your transplant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after their living donor liver transplant to assess for biliary complications.

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NCT07102550

Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

Recruiting
PHASE2Ages 18+InterventionalPrevention
Choon Hyuck David Kwon
~40 participants
Updated 2025-08-03 on ClinicalTrials.gov
What's tested:MiMedx AmnioFix

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biliary complications
Measured over 1 year post living donor liver transplant

Conditions

Liver Transplant

Explore related trials

Liver Transplantation

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Choon Hyuck D Kwon, MD, PhD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Erlind Allkushi
[email protected]
2164440223
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults \>/= 18 years old
Recipient of LDLT

Exclusion

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)
Patients who do not wish to participate
Children, cognitively-impaired persons, pregnant women, students and house staff under the direct supervision of the investigator are considered vulnerable populations and will, therefore, be excluded from participation.

What this trial measures

  • Biliary complications1 year post living donor liver transplant

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