Liver TransplantPhase 2NCT07102550
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue
A Phase 2 study testing MiMedx AmnioFix in people with Liver Transplant, run by Jaekeun Kim at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- MiMedx AmnioFix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >/= 18 years old
- Recipient of LDLT
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Erlind Allkushi, 2164440223, allkuse2@ccf.org
Mary Bilancini, 2164448983, bilancm@ccf.org
About this study
Official title: Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
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.
Read the detailed 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:
- 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?
- What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting?
Participants will:
- undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits.
- consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant.
- 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
- Liver Transplant
- Being tested
- MiMedx AmnioFix
- Keywords
- Living Donor Liver Transplant, Liver Transplant Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiMedx AmnioFixBiological
MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.
| Study group | Role | What they receive |
|---|---|---|
| Living Donor Liver Transplant (LDLT) graft recipient | Other | LDLT recipient with MiMedx placental graft placement Receives: Biological: MiMedx AmnioFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post living donor liver transplant
Secondary outcomes (4)
Post-operative Complication Rates
Rates of postoperative complications and outcomes including: Re-operation, acute or chronic graft rejection, procedural intervention (in total and biliary in nature), delayed graft function, primary graft non-function, surgical site infection
Measured: 1 year post living donor liver transplant
Post-operative Hospital Length of Stay
Hospital length of stay
Measured: From date of transplant until date of discharge from hospital, assessed up to 365 days
Post-operative ICU Length of Stay
ICU length of stay (days)
Measured: From date of transplant until date of transfer out of ICU, assessed up to 365 days
Readmissions
Number of readmissions post-operatively
Measured: 1 year post living donor liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start29 Oct 2024
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaekeun Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaekeun Kim, The Cleveland Clinic
- Investigators
- Jaekeun Kim, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102550
- Sponsor's protocol ID
- 23-829
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07102550
- Acronym / sponsor ID
- 23-829
- Conditions
- Liver Transplant
- Keywords
- Living Donor Liver Transplant, Liver Transplant Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jaekeun KimUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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?
- What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting?
Participants will:
- undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits.
- consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living Donor Liver Transplant (LDLT) graft recipient | Other | Biological: MiMedx AmnioFixLDLT recipient with MiMedx placental graft placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults >/= 18 years old
- Recipient of LDLT
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiMedx AmnioFixMiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant. | Biological | Living Donor Liver Transplant (LDLT) graft recipient |
Primary outcome
Biliary complications
Time frame: 1 year post living donor liver transplant
Biliary complications will be defined as any confirmed leakage of bile into the peritoneal cavity outside of the ductal system or biliary stricture.
4 secondary outcomes
Post-operative Complication Rates
Time frame: 1 year post living donor liver transplant
Post-operative Hospital Length of Stay
Time frame: From date of transplant until date of discharge from hospital, assessed up to 365 days
Post-operative ICU Length of Stay
Time frame: From date of transplant until date of transfer out of ICU, assessed up to 365 days
Readmissions
Time frame: 1 year post living donor liver transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaekeun Kim, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MiMedx AmnioFix in people with Liver Transplant, run by Jaekeun Kim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erlind Allkushi (2164440223, allkuse2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biliary complications (time frame: 1 year post living donor liver transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.