Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

NCT07102550 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-829
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplant

Keywords

Living Donor Liver Transplant; Liver Transplant Complications

Outcome Measures

Primary Outcomes (1)

• Biliary complications

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

  1 year post living donor liver transplant

Secondary Outcomes (4)

• Post-operative Complication Rates

  1 year post living donor liver transplant

• Post-operative Hospital Length of Stay

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

• Post-operative ICU Length of Stay

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

• Readmissions

  1 year post living donor liver transplant

Study Arms (1)

Living Donor Liver Transplant (LDLT) graft recipient

OTHER

LDLT recipient with MiMedx placental graft placement

Biological: MiMedx AmnioFix

Interventions

MiMedx AmnioFix BIOLOGICAL

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

Living Donor Liver Transplant (LDLT) graft recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Choon Hyuck David Kwon: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Choon Hyuck D Kwon, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erlind Allkushi

CONTACT

2164440223; allkuse2@ccf.org

Mary Bilancini

CONTACT

2164448983; bilancm@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 3, 2025
• Study Start: October 29, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)