Amniotic (placental) tissue to protect the bile-duct connection after living-donor liver transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, non-randomized phase 2 pilot enrolls adult recipients of living-donor liver transplants at the Cleveland Clinic who consent to placement of a MiMedx AmnioFix placental tissue graft around the biliary anastomosis during surgery. The graft is intended as a protective barrier to support healing of the bile-duct connection. Participants receive standard pre- and post-operative care and the study team reviews medical records for biliary complications and other postoperative outcomes for up to one year. The primary focus is safety, with descriptive reporting of biliary complication rates and other postoperative events compared to historical expectations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Jaekeun Kim, MD, PhD — The Cleveland Clinic
• Study coordinator: Erlind Allkushi
• Email: allkuse2@ccf.org
• Phone: 2164440223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.