Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
- Conditions
- Alcoholic Cirrhosis
- Interventions
- Biological: Cellgram-LC
- Registration Number
- NCT05093881
- Lead Sponsor
- Pharmicell Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Those who participated in PMC-P-07 clinical trials and received Cellgram-LC
- Those who voluntarily agreed in writing to participate in this investigation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cellgram-LC Cellgram-LC Patients with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Gangwon National University Hospital
🇰🇷ChunCheon, Korea, Republic of
Hallym Univ. Medical Center
🇰🇷ChunCheon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung-si, Korea, Republic of
Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Yongin Severance Hospital
🇰🇷Yongin, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of