Recruiting
Phase 2

Placental Tissue Grafts

Sponsor:

Choon Hyuck David Kwon

Code:

NCT07102550

Conditions

Liver Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MiMedx AmnioFix

Study Details

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

Study ID

NCT07102550

Start date

Oct 29, 2024

Status verified date

Jul, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Living Donor Liver Transplant (LDLT) graft recipient

LDLT recipient with MiMedx placental graft placement

Interventions

MiMedx AmnioFix

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Erlind Allkushi

2164440223allkuse2@ccf.org

Mary Bilancini

2164448983bilancm@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Erlind Allkushi

216-444-0223allkuse2@ccf.org

Mary Bilancini

2164448983bilancm@ccf.org

Principal Investigator:

Choon Hyuck D Kwon, MD, PhD

More Information

Sponsor

Choon Hyuck David Kwon

Last update posted

Aug 3, 2025

Last verified

Jul, 2025

Keywords

  • Living Donor Liver Transplant
  • Liver Transplant Complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Choon Hyuck David Kwon on 2025-08-03.