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NCT Number: NCT07102550

Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults. MiMedx placental tissue grafts are registered with the FDA for homologous use in any location in the body as a protective barrier that supports the healing cascade, which is the use the investigators intend it for in this trial.

The main questions this study aims to answer are:

  • Can bile-duct reinforcement using MiMedx placental tissue grafting demonstrate equal-to-improved biliary complications in patients who are recipients of living donor liver transplant?
  • What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting?

Participants will:

  • undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits.
  • consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant.
  • consent to allow the study team to perform a review of their medial records after each standard-of-care follow-up visit to assess presence of any biliary complications up to 1 year post-transplant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults >/= 18 years old
  • Recipient of LDLT

Exclusion criteria

  • 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.

Treatment and study plan

MiMedx AmnioFix

Biological

MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.

Primary outcomes

  1. Biliary complications

    Time frame: 1 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.

Secondary outcomes

  1. Post-operative Complication Rates

    Time frame: 1 year post living donor liver transplant

    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

  2. Post-operative Hospital Length of Stay

    Time frame: From date of transplant until date of discharge from hospital, assessed up to 365 days

    Hospital length of stay

  3. Post-operative ICU Length of Stay

    Time frame: From date of transplant until date of transfer out of ICU, assessed up to 365 days

    ICU length of stay (days)

  4. Readmissions

    Time frame: 1 year post living donor liver transplant

    Number of readmissions post-operatively

Study contacts

Contact information is provided by the study sponsor or research team.

Erlind Allkushi

CONTACT

[email protected]

2164440223

Mary Bilancini

CONTACT

[email protected]

2164448983

Sponsors and collaborators

Lead sponsor

Choon Hyuck David Kwon

Other

Registry information

Official study title

Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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