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This Long-term follow-up is designed to evaluate the safety of patient with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.
To evaluate the safety for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellgram-LC | Experimental | Patients with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellgram-LC | Biological | Patients who had administered Cellgram-LC in PMC-P-07 study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of AESI | death, neoplasms or malignancies in tissues or organs, Immune response including exacerbation or new outbreaks of previous autoimmune diseases, Other delayed AE related to Cellgram LC) | For 5 years |
| Rate of Liver transplant | Liver transplant | For 5 years |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIYEOUN JEONG | Contact | 82-2-3496-0134 | jyjeong@pharmicell.com |
| Name | Affiliation | Role |
|---|---|---|
| Moonyoung Kim | Wonju Severance Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Hospital | Recruiting | Bucheon-si | South Korea |
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| Soonchunhyang University Hospital | Recruiting | Cheonan | South Korea |
|
| Gangwon National University Hospital | Recruiting | Chuncheon | South Korea |
|
| Hallym Univ. Medical Center | Recruiting | Chuncheon | South Korea |
|
| Gangneung Asan Hospital | Recruiting | Gangneung-si | South Korea |
|
| Eunpyeong St. Mary's Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Soonchunhyang University Hospital | Recruiting | Seoul | South Korea |
|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | South Korea |
|
| Yongin Severance Hospital | Recruiting | Yongin | South Korea |
|
| 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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