None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Standard therapy group will receive best supportive care for the disease.
lifeliver-treated group
1. Method of administration : The plasma is separated continuou
s blood and administered in the form of extracorporeal circulation circulating the hepatocyte-loaded reactor.
2. Duration, frequency and interval : The dose should be administered within 16 hours of t
s judgement.
Sponsors
HLB CELL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 60 years of age 2. Acute or acute-on-chronic liver failure patients who is waiting for liver transplantation (Korean Netmwork for Organ Sharing(KONOS) liver transplant emergency grade 2 or 3) 3. Hepatic encephalopathy grade II or above 4. INR (international normalized ratio) 2.0 or above 5. Serum ammonia 56 micromole/L or above 6. Total bilirubin 5mg/dL or above 7. Body weight 45kg or above 8. Patient who can not expect effective treatment or prolonged survival 9. Patient or patient's legal representative willing to cooperate and comply with the restrictions during the trial period 10. Patient or patient's legal representative willing to provide informed consent and commit to study procedures
Exclusion criteria
Exclusion criteria: 1. Patient who has contraindication to plasmapheresis 2. Severe hypotension (systolic blood pressure 80mmHg or less) 3. Platelet < 15,000/mm3 4. Contraindications to liver transplantation (sepsis, severe heart disease, uncontrollable hemorrhage, irreversible brain damage) 5. Cerebral hemorrhage 6. Positive HIV infection 7. Serious or life-threatening hemorrhage just before initiation of the study 8. Patients with high gastrointestinal bleeding tendency (a history or suspicion of gastrointestinal bleeding within last 3 months) 9. Hepatocellular carcinoma patient with 7 (or more) tumors or a 6cm (or larger) diameter single tumor 10. Pregnant or lactating women 11. Antibiotics (beta-lactam family) hypersensitive and streptomycin, amphotericin B sensitive patients 12. Patients with inappropriate condition to participate the study under investigator's judgement 13. Patients currently participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety : Incidence of transition of PERV (Porcine Endogenous Retrovirus) (for experimental group only);Efficacy : To campare of 30 days survival rate of LifeLiver treatment with best supportive care;Safety : Occurrence of clinical safety laboratory adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy : Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's MELD score (range of minimum 6 to maximum 40);Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's hepatic encephalopathy grade (range of minimum 1 to maximum 4);Efficacy : To compare of 14 days survival rate of LiveLiver treatment with best supportive care;Efficacy : To compare Median value of duration of survival between experimental group and control group;Efficacy : Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's Glasgow Coma Scale (range of minimum 3 to maximum 15);Efficacy : 4.Kaplan-Meier estimate of subjects with 31= MELD score =37 : To compare Kaplan-Meier estimate of both groups at 14 days and 30 days;Efficacy :Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's value of blood ammonia;Efficacy : Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's value of inflammatory cytokines (TNF-a, Interleukin-6, Interleukin-10);Efficacy :3.Kaplan-Meier estimate of subjects with MELD (Modell for End-stage Liver Disease) score >37 : To compare Kaplan-Meier estimate of both (experimental and control) groups at 14 days and 30 days | — |
Countries
Korea, Republic of
Contacts
Public ContactSinn Dong Hyun
Samsung Medical Center
Outcome results
None listed