Alcoholic Liver Cirrhosis
Conditions
Brief summary
If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability. A participant that satisfies all selection and exclusion criteria is assigned randomly to a test group (1-time or 2-time injection group) or control group (no-cell therapy group). Participants assigned to the 1-time injection group conduct cell therapy within 1 month after bone marrow aspiration. Before implementing cell therapy, implement hepatic artery catheterization which inserts a catheter into the hepatic artery through the right aorta femoralis and inject 5X107 autologous bone marrow-derived mesenchymal stem cells. Participants assigned to the 2-time injection group store 1-time injection amount of mesenchymal stem cells while being cultivated after sampled from the bone marrow, and will re-inject autologous mesenchymal stem cells within 1 month after first injection. Participants will make a total of 8 hospital visits on a 4-week interval after registration, and effectiveness and safety will be evaluated based on a fixed procedure on every visit.
Interventions
BIOLOGICALLivercellgram
Livercellgram * Dosage form and appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip ② Component: Autologous bone marrow-derived mesenchymal stem cell ③ Amount: 5X107 cells, 1-time or 2-time injection ④ Storage Method: Stored in airtight container at 20\ 25℃ * Injection Method: Directly inject into liver through hepatic artery
Sponsors
Pharmicell Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically or clinically diagnosed as alcoholic liver cirrhosis 2. Classified as Child-Pugh grade B or C 3. Age of 20 \ 70 years 4. Capable of conducting hepatic artery catheterization which inserts a catheter up to the hepatic artery 5. In the case of fertile women, confirmed as negative in pregnancy test when screening, and agreed to avoid pregnancy during the trial period 6. 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) 7. Patient who can agree to participate in the clinical trial by oneself or by one's legal representative 8. Able to conduct the clinical trial according to the protocol
Exclusion criteria
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 |
|---|---|
| Histopathological evaluation (Fibrosis Grade - Laennec Scoring System) | 6 month after cell therapy |
Secondary
| Measure | Time frame |
|---|---|
| Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT) | 6month |
| Visual Inspection (Liver volume, Fibroscan) | 6month |
| Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison) | 6month |
| MELD Score | 6month |
| Child-Pugh grade | 6month |
Countries
South Korea
Outcome results
None listed