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Recombinant Protein

1 for Ischemia Reperfusion Injury (YSPSL Trial)

Phase 2
Waitlist Available
Research Sponsored by Y's Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post trasplant
Awards & highlights

YSPSL Trial Summary

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. This study is an extension of the recent pilot study YSPSL-0002 with an almost identical study protocol. The rationale of this and the previous study is based on the recent observation that 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.

Eligible Conditions
  • Ischemia Reperfusion Injury

YSPSL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post trasplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post trasplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety will be evaluated by clinical and laboratory assessments, an abbreviated pharmacokinetic (PK) profile of the administered dose of YSPSL, and graft function and patient and graft survival through 6 months post-transplant.
Secondary outcome measures
To evaluate the potential efficacy of prophylaxis with YSPSL on ischemia reperfusion injury (IRI) as assessed by proposed efficacy evaluations of IRI in liver transplants, in patients who meet eligibility criteria for the trial.

Side effects data

From 2009 Phase 3 trial • 8323 Patients • NCT00057330
87%
Pain
48%
Upper respiratory tract infection
45%
Fatigue
42%
Headache
36%
Redness
33%
Malaise
31%
Swelling
9%
Fever
1%
Abortion spontaneous
100%
80%
60%
40%
20%
0%
Study treatment Arm
Herpes Simplex Virus Group
Havrix Group

YSPSL Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Active Group: (18 subjects) YSPSL administered as an ex vivo flush (20 mg YSPSL in Viaspan® 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. One extra IV dose of 1 mg/kg will be given at the end of the procedure only to patients that have experienced an intraoperative blood loss of greater than 10 units.
Group II: 2Placebo Group1 Intervention
Placebo Control: (18 subjects) Ex vivo flush of placebo control (200 mL Viaspan®) 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. One additional infusion of 0.1 mL/kg placebo control (saline) will be given at the end of the procedure to patients that have experienced an intraoperative blood loss of greater than 10 units.

Find a Location

Who is running the clinical trial?

Y's Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
87 Total Patients Enrolled
Stefan Hemmerich, PhDStudy DirectorY's Therapeutics, Inc.
3 Previous Clinical Trials
87 Total Patients Enrolled

Frequently Asked Questions

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~2 spots leftby Apr 2025