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| Name | Class |
|---|---|
| Mid-America Transplant | OTHER |
| OrganOx Ltd. | INDUSTRY |
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This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.
This is a single center, prospective, non-randomized, clinical trial to assess the feasibility of successful transplantation of NMP-treated livers to patients. First, up to 71 marginal livers declined for transplantation will be treated with NMP using the OrganOx® metra device and tested for viability using previously defined criteria. NMP-treated viable livers will be subsequently transplanted to patients (n=5 in the 1st stage; additional 10 transplantation in the 2nd stage; additional 10 transplantation in the 3rd stage: total N=25). Patients will be closely followed for clinical outcomes of the transplantation during 6 months post-transplantation. The follow-up will also be extended up to 1 year post-transplantation. The trial will compare the results to those of three comparison groups - 1) matched patients who received liver transplantation at Washington University/Barnes Jewish Hospital; 2) matched patients who received DBD liver transplantation in the OPTN/UNOS database; and 3) matched patients who received DCD liver transplantation in the OPTN/UNOS database. Given that patient safety is the priority, the trial uses a multi-stage design in which the study stops earlier when NMP-treated liver transplantation is observed to be ineffective (see trial schema in Section 3.1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Declined liver in Normothermic Machine Perfusion (NMP) | Experimental | The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. NMP of the donated declined liver utilizing the OrganOx® metra device. NMP involves (warm) machine perfusion with oxygenated blood at normal body temperature. During NMP, the device also allows for ongoing assessment of donor liver function and further viability assessment to help determine suitability of the organ for transplant. |
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| Standard cold preservation of liver | Active Comparator | This group will receive liver transplant using the standard method of preservation. There will be 3 comparison groups: one local comparison group and two comparison groups from the national UNOS data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Declined liver in Normothermic Machine Perfusion (NMP) | Device | The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with no graft failure at 6 months | 6-month graft and patient survival as an indicator of liver function after NMP- treated liver transplantation. 6-month patient survival rate will be estimated as the number of patients who survive by 6 months post-transplantation with NMP-treated livers This is a nationally accepted outcome routinely assessed in organ transplantation programs. 6-month graft survival rate = (Number of patients with no graft failure at 6-month post transplantation)/(Total number patients who received transplantation with NMP-treated liver) 6-month graft and patient survival rates will be compared to those in each comparison group using Fisher's Exact test. Kaplan-Meier survival curve will be examined as well. | Up to 6 months |
| Total number of patients who received NMP-treated liver transplantation | 6-month patient survival rate will be estimated as the number of patients who survive by 6 months post-transplantation with NMP-treated livers divided by the total number of patients who received NMP-treated liver transplantation. 6-month patient survival rate = (Number of patients who survive by 6-month post transplantation)/(Total number patients who received transplantation with NMP-treated liver) 6-month graft and patient survival rates will be compared to those in each comparison group using Fisher's Exact test. Kaplan-Meier survival curve will be examined as well. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess liver graft function and survival after transplantation | Liver graft function assessment: early allograft dysfunction (EAD) and primary non-function (PNF). Long-term survivals of patient and graft will provide additional evidence on the safety of using NMP-treated liver for transplantation. | 3 months to 1 year |
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PRE-NMP DECLINED LIVER ELIGIBILITY:
Inclusion Criteria:
Exclusion Criteria:
LIVER TRANSPLANTATION - HUMAN
Inclusion criteria:
Subject must be greater than or equal to 18 years of age.
Subject with end-stage liver disease who is actively listed for primary liver transplantation on the UNOS waiting list
Subject, or a legally authorized representative, has given informed consent to participate in the study
Subject has a frailty classification of "Mild frailty/No frailty (Robust)", based on the Liver Frailty Index (LFI), which has been assessed within 6 months prior to liver transplant OR Subject is able to perform >350 m on a 6 minute walk test (6MWT) within 6 months prior to liver transplant.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Will Chapman, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36728302 | Derived | Olumba FC, Zhou F, Park Y, Chapman WC; RESTORE Investigators Group. Normothermic Machine Perfusion for Declined Livers: A Strategy to Rescue Marginal Livers for Transplantation. J Am Coll Surg. 2023 Apr 1;236(4):614-625. doi: 10.1097/XCS.0000000000000555. Epub 2023 Jan 11. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2026 | May 19, 2026 | 10 | ||
| Jun 3, 2026 |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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To successfully transplant NMP-treated livers to patients that would otherwise have been discarded.
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| Standard cold preservation of liver | Procedure | The study will have three comparison groups - one local comparison group and two comparison groups from the national UNOS data. Comparison group 1 will be patients who received a standard liver transplantation and follow-up care at the Washington University/ Barnes Jewish Hospital (n=50). Patients will be matched by a 5-year age category, sex, MELD score, donor liver graft type (e.g., DCD, DBD), donor age (5-year category), and donor sex. Washington University/ Barnes Jewish Hospital maintains a liver transplantation database that prospectively collects pre- and post-transplantation patient data. Comparison group 2 will be patients who received DBD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex. Comparison group 3 will be patients who received DCD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex. |
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| Assess survival after transplantation |
90-day graft and patient survival 1-year graft and patient survival Long-term survivals of patient and graft will provide additional evidence on the safety of using NMP-treated liver for transplantation. |
| 3 months to 1 year |
| To assess morbidity associated with receipt of NMP-treated liver |
Incidence rates of adverse outcomes will provide additional evidence on the safety of using previously declined, NMP-treated liver for transplantation | 3 months to 1 year |
| Quality of Life Score Questionnaire | Quality of life score using EQ-5D-5L questionnaire. To evaluate the effect of liver transplantation on patient's quality of life. Quality of life questionnaire will be completed at 3 timepoints: Baseline (prior to transplantation), 90 days and month 6 | 6 months |
| Estimate proportion of declined livers that can be used for transplantation following NMP | To estimate the proportion of declined livers that can be used for transplantation following NMP. Rescue-rate that is the number of viable NMP- treated livers divided by the total number of NMP-treated livers. The organ recovery rate provides additional evidence on the feasibility of using NMP-treated liver for transplantation. | 12 months to 18 months |
| Jun 30, 2026 |
| 11 |