YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation

This is an interventional prevention trial for Liver Diseases focused on measuring Delayed graft function Read More

Inclusion Criteria:

1. Patient will be a recipient of a primary (first) ABO compatible cadaveric liver allograft;
2. Patient's age is >=18 years;
3. Patient is not a recipient of a multivisceral transplant or simultaneous kidney transplant;
4. Patient has not undergone prior organ or cellular transplant of any type;
5. Patient has a Model for End Stage Liver Disease (MELD) score of <28;
6. Cold ischemia time (CIT) anticipated to be less than 12 hours;
7. Donor liver procured by UCLA liver team;
8. Veno-veno bypass is not planned to be used for the patient (e.g. no prior surgery or other factor that indicates a risk for excessive blood loss and therefore a need for veno-veno bypass +/- autologous recovery during surgery);
9. For patients who are women of childbearing potential, patient has a negative pregnancy test (either urine or serum) within 48 hours prior to transplant;
10. Patient (male and female) is willing to use an acceptable form of birth control for at least 3 months post-treatment; and
11. Patient is willing and able to sign informed consent.

Exclusion Criteria:

1. Patient has a prior organ transplant of any type;
2. Patient has known allergic or intolerance reactions to human immune globulins, antibodies, or components of the formulation or known contraindication to administration of YSPSL;
3. Patient has an uncontrolled active infection (on antibiotics with controlled infection is not an exclusion) ;
4. Patient has active Hepatitis B virus (HBV)/transplant for HBV related cirrhosis;
5. Patient has previously participated in this study or another study with YSPSL;
6. Patient has received investigational therapy within 90 days prior to the transplant procedure;
7. Patient has current drug or alcohol abuse or, in the opinion of the investigator, is at risk for poor compliance with the visits in this protocol (no drug testing required);
8. Patient is a pregnant or nursing female, a female of childbearing potential planning to become pregnant within the duration of this study, or is not practicing birth control;
9. Patient is planned to receive a living donor liver transplant;
10. Patient lives >200 miles away or otherwise is not able to participate in study follow-up visits;
11. Donor body mass index >28;
12. Donor liver biopsy >20% macrosteototic fat;
13. Donor age >65.