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The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of ischemia reperfusion injury following liver transplantation by administering YSPSL into the liver graft directly ex vivo via the portal vein and to the recipient intravenously prior to reperfusion. Recently, P-selectin expression has been associated in liver grafts with prolonged cold storage times and rejection. By examining biomarkers of IRI including P-selectin by immunohistochemistry and/or quantitative PCR, liver histology and hepatic blood flow using established techniques, the goal of this study is to evaluate the feasibility of using these modalities for future studies of safety and efficacy.
This will be a single-center, single-dose study. The study will be a randomized, double-blind, placebo-controlled, single-dose study. Patients who are undergoing cadaveric orthotopic liver transplantation and are at risk for development of DGF, based upon known risk factors, will be eligible to participate in the study. 12 patients will be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | YSPSL (rPSGL-Ig) |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YSPSL | Drug | YSPSL administered as an ex vivo flush (20 mg YSPSL in ViaspanĀ® 200 mL total volume) into the portal vein prior to transplant at the back table; YSPSL 1 mg/kg administered IV to the transplant recipient prior to arterial reperfusion of the liver. |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed graft function post transplant | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function parameters through 6 months post transplant | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Hemmerich, PhD | Y's Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Medicine | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C055206 | University of Wisconsin-lactobionate solution |
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| Placebo | Drug | Ex vivo flush of placebo control (200 mL ViaspanĀ®) into the portal vein prior to transplant and 0.1 mL/kg placebo control (saline) IV to the transplant recipient prior to arterial reperfusion of the liver. |
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