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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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
Pharmicell Co., Ltd.
Seoul, South Korea
Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)
Time frame: 6 month after cell therapy
Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison)
Time frame: 6month
MELD Score
Time frame: 6month
Child-Pugh grade
Time frame: 6month
Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT)
Time frame: 6month
Visual Inspection (Liver volume, Fibroscan)
Time frame: 6month
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