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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Best Supportive care | |
| 1-time injection group: Livercellgram | Experimental | Within 1 month after extracting bone marrow, directly inject 5X107 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery. |
|
| 2-time injection group: Livercellgram | Experimental | Within 1 month after extracting bone marrow, directly inject 5X107 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery. Within 1 month after cell injection, re-inject autologous bone marrow-derived mesenchymal stem cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livercellgram | Biological | Livercellgram
|
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological evaluation (Fibrosis Grade - Laennec Scoring System) | 6 month after cell therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison) | 6month | |
| MELD Score | 6month | |
| Child-Pugh grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soon Koo Baik, M.D.,Ph.D | Yonsei University, Wonju Christian Hospital | Principal Investigator |
| Si-Hyun Bae, M.D.,Ph.D | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmicell Co., Ltd. | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40916722 | Derived | Han SK, Kim SH, Koh SB, Kim MY. Transplantation of Autologous Bone Marrow-Derived Mesenchymal Stem Cells for the Treatment of Decompensated Liver Cirrhosis: A Real-World Evidence Study in a Population-Based Cohort. Gut Liver. 2026 May 15;20(3):452-457. doi: 10.5009/gnl250016. Epub 2025 Sep 8. |
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|
|
| 6month |
| Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT) | 6month |
| Visual Inspection (Liver volume, Fibroscan) | 6month |
| ID | Term |
|---|---|
| D008104 | Liver Cirrhosis, Alcoholic |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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