Alcoholic Cirrhosis
Conditions
Brief summary
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.
Detailed description
To evaluate the safety for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.
Interventions
Patients who had administered Cellgram-LC in PMC-P-07 study
Sponsors
Study design
Eligibility
Inclusion criteria
1. Those who participated in PMC-P-07 clinical trials and received Cellgram-LC 2. Those who voluntarily agreed in writing to participate in this investigation
Exclusion criteria
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Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of AESI | For 5 years | 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) |
| Rate of Liver transplant | For 5 years | Liver transplant |
Countries
South Korea