Actively Recruiting
Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
Led by Pharmicell Co., Ltd. · Updated on 2024-03-21
200
Participants Needed
11
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected hepatic artery.
CONDITIONS
Official Title
Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 70 years at screening
- Diagnosed with alcoholic cirrhosis confirmed by alcohol history, imaging, pathology, and clinical symptoms
- Child-Pugh grade B or C with a score of 7 or more
- Expected survival of more than 1 year as judged by the investigator
- Able to undergo hepatic artery catheterization
- Women of childbearing potential must have a negative pregnancy test and agree to use approved contraception during the trial
- Able to comply with the clinical trial protocol
- Provided written informed consent voluntarily to participate
You will not qualify if you...
- History of solid cancer including hepatocellular carcinoma within 5 years before screening or current chemotherapy for solid cancer
- Confirmed hepatocellular carcinoma by screening tests
- Previous portal systemic shunting in the jugular vein
- Alcohol use or hepatotoxic drug use within 6 months before screening
- Use of high-dose steroids, immunosuppressants, or antimicrobials for severe infections for at least 1 month before screening
- Major surgery, long-term biopsy, or significant trauma within 3 months before screening
- History of gastrointestinal bleeding within 10 days before screening
- Presence of certain medical histories or concomitant diseases as judged at screening
- Positive serologic tests for HIV, HAV, HBV, HCV, or syphilis
- Bone marrow disease preventing bone marrow collection
- History of gentamicin hypersensitivity
- Pregnant or lactating women
- Substance abuse within 1 year before screening
- Participation in other clinical trials within 1 month before screening involving treatment
- Previous participation in cell therapy clinical trials
- Other complications or conditions judged inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Soonchunhyang University Hospital
Bucheon-si, South Korea
Actively Recruiting
2
Soonchunhyang University Hospital
Cheonan, South Korea
Actively Recruiting
3
Gangwon National University Hospital
Chuncheon, South Korea
Actively Recruiting
4
Hallym Univ. Medical Center
Chuncheon, South Korea
Actively Recruiting
5
Gangneung Asan Hospital
Gangneung-si, South Korea
Actively Recruiting
6
Eunpyeong St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
7
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
8
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
9
Soonchunhyang University Hospital
Seoul, South Korea
Actively Recruiting
10
Wonju Severance Christian Hospital
Wŏnju, South Korea
Actively Recruiting
11
Yongin Severance Hospital
Yŏngin, South Korea
Actively Recruiting
Research Team
J
JIYEOUN JEONG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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