Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
Key facts
- Who runs it
- Pharmicell Co., Ltd.
- Where
- South Korea15 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 200 people, planned
- Started
- 19 Apr 2021
- Expected to end
- 1 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cellgram-LC
- Best Supportive Care (BSC)
- Record updated
- 21 September 2026
Who can take part
- Age
- 20 years to 71 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- At the time of screening, 19 or 70 years
- Patients diagnosed with alcoholic cirrhosis by combining alcohol history, imaging and pathological examination results, and clinical symptoms at screening, and belonging to Child-Pugh grade B or C (Child-Pugh score of 7 or more)
- Those whose survival period is more than 1 year when judged by the tester
- Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner
- In the case of women of childbearing potential, a person who was confirmed negative in the pregnancy test at screening and agreed to use contraception* by the method permitted for this clinical trial during the clinical trial
- Those who can conduct clinical trials according to the clinical trial protocol
- A person who has consented in writing to voluntarily participate in this clinical trial
Who cannot take part
- Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening
- Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening
- Those who participated in other clinical trials within one month before screening and administered (or applied) clinical trial drugs (or medical devices)
- Those who previously participated in clinical trials related to cell therapy
- Those with a history of solid cancer including Hepatocellular Carcinoma (HCC) (within 5 years before screening), those who have been diagnosed with solid cancer and are currently undergoing chemotherapy or those whose hepatocellular carcinoma has been confirmed by screening tests
- Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening
- Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening
- serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor
- Patients unable to collect bone marrow due to bone marrow disease
- Those with a history of gentamicin hypersensitivity reaction
- Those whose medical history or accompanying diseases following the screening time is confirmed; If you have not been diagnosed with a malignant blood disease (acute myelogenous leukemia, acute lymphocytic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma, multiple myelopathy); Severe aplastic anemia; Liver transplant history; Liver diseases of other causes besides alcoholic cirrhosis: hepatitis B and C, autoimmune liver disease (primary cholangitis, primary sclerosing cholangitis and autoimmune hepatitis, etc.), weak liver toxicity, non-alcoholic fatty liver disease , NAFLD), Wilson's disease, iron excess, alpha-1-antitrypsin deficiency, etc.); Extrahepatic biliary stenosis; Active portal vein or hepatic vein thrombosis; Heart failure or respiratory failure; Severe renal impairment (when the result of serum creatinine test exceeds 1.5 times the upper limit of normal); Acute or chronic infection requiring systemic treatment; Severe coagulation disorder (if the tester judges it as a severe coagulation disorder or one of the following 1 to 3; 1. bleeding predisposition, 2. coagulation, 3. platelet≤50,000/mm3 and INR≥1.5)
- Patients who underwent portal systemic shunting in the jugular vein
- Pregnant or lactating women
- Those with substance abuse experience within 1 year before screening
- Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 71 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis.
Read full original descriptionShow less
The main questions it aims to answer are:
* Is Cellgram-LC superior to best supportive care (BSC) in patients with alcoholic cirrhosis? * What medical problems do participants have after receiving Cellgram-LC compared with BSC?
Participants will:
* Receive a single dose of Cellgram-LC at Week 0 or receive best supportive care according to their assigned study group. * Attend clinic visits for scheduled assessments at Week 4 and Months 3, 6, 9, 12, 18, and 24. * Complete scheduled telephone follow-up at Months 2, 4, 5, 7, 8, 10, 11, 15, 21, 27, 30, 33, and 36. * Be followed for transplant-free survival and other study outcomes.
The 2 groups in the trial
- Control groupExisting treatment, for comparison
Best supportive care.
Treatment: Best Supportive Care (BSC)
- Cellgram-LCTreatment being tested
Participants receive a single dose of Cellgram-LC through the hepatic artery.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis
- Fit questions
- Built from NCT04689152, who can take part
- Record updated
- 21 September 2026