NCT07102550

Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Choon Hyuck David Kwon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. 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? 2. What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting? Participants will: 1. undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits. 2. consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant. 3. 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.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
BIOLOGICAL	MiMedx AmnioFix	MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.

Timeline

• Start date: 2024-10-29
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study