Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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

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Liver Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Living Donor Liver Transplant (LDLT) graft recipient

LDLT recipient with MiMedx placental graft placement

Group Type OTHER

MiMedx AmnioFix

Intervention Type BIOLOGICAL

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

Interventions

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MiMedx AmnioFix

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No