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This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).
This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).
This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic liver cirrhosis. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, occurrence of adverse events and serious adverse events, clinical laboratory tests, vital sign, physical examinations.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no Intervention | Long-term follow up of no intervention group | ||
| 1-time injection group | Long-term follow up of 1-time injection group | ||
| 2-time injection group | Long-term follow up of 2-time injection group |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations |
| 5-year(+30 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have completed the Livercellgram phase 2 study and can agree to participate in the long term observation study by oneself.
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| Name | Affiliation | Role |
|---|---|---|
| Soon Koo Baik, M.D.,Ph.D | Wonju Severance Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
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| ID | Term |
|---|---|
| D008104 | Liver Cirrhosis, Alcoholic |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| 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 |