None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Before implementing cell therapy, implement hepatic artery catheterization which inserts a catheter into the hepatic artery through the right aorta femoralis and inject
Sponsors
FCB-Pharmicell
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or clinically diagnosed as alcoholic liver cirrhosis (2) Classified as Child-Pugh grade B or C (3) Capable of conducting hepatic artery catheterization which inserts a catheter up to the hepatic artery (4) In the case of fertile women, confirmed as negative in pregnancy test when screening, and agreed to avoid pregnancy during the trial period (5) Women capable of pregnancy must satisfy the following conditions; Has been through menopause for at least 1 year, has no possibility of pregnancy via surgery/procedure, or effectively used acceptable contraceptive methods (Intrauterine device-loop, mirena, diaphragm or condom/femidom, oral contraceptive pills, non-oral contraceptives) (6) Patient who can agree to participate in the clinical trial by oneself or by one's legal representative (7) Able to conduct the clinical trial according to the protocol
Exclusion criteria
Exclusion criteria: Patients who apply to at least one of the following exclusion criteria must be excluded from this clinical trial. (1) Diagnosed with malignant hematologic disease (acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma) and not cured from it (2) Patient with severe aplastic anemia (3) Has a medical record of solid cancer(within 5 years prior to screening), or diagnosed with solid cancer and currently receiving cancer treatment (4) Incapable of conducting hepatic artery (5) Patient who consumed alcohol and took hepatotoxic drugs within 6 months prior to registration (6) Has continuously taken a large amount of steroids or antibiotics for 1 month prior to registration (7) Judged by a researcher to have had major orthopedic surgery, organ biopsy, or similar external injury within 3 months prior to registration (8) Evidence of active autoimmune liver disease (9) Patient with extrahepatic biliary stricture (10) Patient who conducted transjugular intrahepatic portosystemic shunt (11) Has active thrombosis of the portal or hepatic veins (12) Patient with sepsis (13) Patient who suffers heart, renal, respiratory failure (14) Patient who is positive in pathogenic test (HIV, Syphilis,HBV,HCV) (15) Pregnant or lactating woman (16) Patient who cannot adapt to the protocol and follow-up observation (17) Patient who has experienced drug abuse for the past 1 year (18) Participated in the other clinical trials within 30 days before registration (19) Patient with any disease or condition which the investigator feel would interfere with trial or the safety of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic Fibrosis Grade - Laennec Scoring System | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver cirrhosis fibrosis grade(Ratio of 1-time injection group to 2-time injection group comparison);MELD score ;Child-Pugh' score ;Liver Function Test(ALT, AST, ALP, Albumin, bilirubin, r-GT);Imaging examination(liver volume, fibroscan) | — |
Countries
Korea, Republic of
Contacts
Public ContactMoon Kim
Yonsei University, Wonju Severance Christian Hospital
Outcome results
None listed