Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Choon Hyuck David Kwon
Study ID
NCT07102550
Phase
PHASE2
Status
Recruiting
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Conditions

  • Liver Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 29, 2024
Status verified
Jul 2025
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Other: Living Donor Liver Transplant (LDLT) graft recipient
    LDLT recipient with MiMedx placental graft placement

Primary Outcome Measure

Biliary complications [ Time Frame: 1 year post living donor liver transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Erlind Allkushi
[email protected]
216-444-0223
Mary Bilancini
[email protected]
2164448983
Choon Hyuck D Kwon, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic· Cleveland, OH

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