Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

Choon Hyuck David Kwon

Status and phase: Enrolling; Phase 2

Conditions: Liver Transplant

Treatments: Biological: MiMedx AmnioFix

Study type: Interventional

Funder types: Other

Identifiers

NCT07102550

23-829

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Living Donor Liver Transplant (LDLT) graft recipient

Other group

Description:

LDLT recipient with MiMedx placental graft placement

Treatment:

Biological: MiMedx AmnioFix