Alcoholic CirrhosisPhase 3Cellgram-LCNCT04689152
Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
A Phase 3 study testing Cellgram-LC in people with Alcoholic Cirrhosis, run by Pharmicell Co., Ltd. at 15 sites in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis. 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… Read more about this study
- Who is it for?
- Ages 20 to 71 years
- Conditions the study is for
- Alcoholic Cirrhosis
- What is being tested?
- Cellgram-LC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 19 Apr 2021to 1 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
- Patients who underwent portal systemic shunting in the jugular vein
- Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening
- Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening
- Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening
- Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening
Show all 25Show fewer
- 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)
- 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
- Pregnant or lactating women
- Those with substance abuse experience within 1 year 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
- Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
South Korea15 sites, 13 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
Sung-hee Kang, +82-31-412-4996, shkang0114@gmail.com
- Recruiting
Soonchunhyang University Hospital
Bucheon-si
Sang-gyun Kim, mcnulty@schmc.ac.kr
- Terminated
Soonchunhyang University Hospital
Cheonan
- Terminated
Gangwon National University Hospital
Chuncheon
- Recruiting
Hallym Univ. Medical Center
Chuncheon
Ki-tae Seok, diarrhea100@hanmail.net
- Recruiting
Gangneung Asan Hospital
Gangneung-si
Gapjin Cheon, 1000@gnah.co.kr
- Recruiting
Eunpyeong St. Mary's Hospital
Seoul
Sihyeon Bae, baesh@catholic.ac.kr
- Recruiting
Gangnam Severance Hospital
Seoul
Hyun-Woong Lee, +82-2-2019-3315, LHWDOC@yuhs.ac
- Recruiting
Korea University Anam Hospital
Seoul
Yeonseok Seo, drseo@korea.ac.kr
- Recruiting
Seoul National University Hospital
Seoul
Jeonghwan Yoon, yoonjh@snu.ac.kr
- Recruiting
Seoul St. Mary's Hospital
Seoul
Jung-Won Jang, +82-2-2258-6015, garden@catholic.ac.kr
- Not yet recruiting
Severance Hospital
Seoul
Seung-Up Kim, +82-2-2228-1982, ksukorea@yuhs.ac
- Recruiting
Soonchunhyang University Hospital
Seoul
Jaeyoung Jang, jyjang@schmc.ac.kr
- Recruiting
Wonju Severance Christian Hospital
Wŏnju
Moonyoung Kim, drkimmy@yonsei.ac.kr
Sun-gu Baek
- Recruiting
Yongin Severance Hospital
Yŏngin
Jakyung Kim, ceciliak@yuhs.ac
About this study
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
The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis.
The main questions it aims to answer are:
Read more
- 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.
- Conditions
- Alcoholic Cirrhosis
- Being tested
- Cellgram-LC, Best Supportive Care (BSC)
- Keywords
- Cellgram-LC, Alcoholic Cirrhosis, Liver Cirrhosis, Mesenchymal Stem Cell, Bone Marrow-Derived Mesenchymal Stem Cell, Cell Therapy, Regenerative Medicine
- Medical subject headings
- Liver Cirrhosis, Alcoholic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellgram-LCBiological
Participants receive a single injection of 7 × 10^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.
Best Supportive Care (BSC)Other
Participants receive best supportive care.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Best supportive care. Receives: Other: Best Supportive Care (BSC) |
| Cellgram-LC | Experimental | Participants receive a single dose of Cellgram-LC through the hepatic artery. Receives: Biological: Cellgram-LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival (TFS)
Transplant free survival (TFS), the median survival time and 95% confidence interval for each group were presented using the Kaplan-Meier method, and the difference in the survival distribution between the two groups was used as a Cox proportional hazards model corrected for stratification Black.
Measured: For 3 years
Secondary outcomes (8)
Survival rate
For the survival rate, the survival rate and 95% confidence interval at each time point are presented using the Kaplan-Meier method, and the difference in survival rate between the two groups is tested using the Z statistic.
Measured: month 24 and 36
Change amount of Child-Pugh score
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
CP score was calculated using five factors: hepatic encephalopathy, prothrombin time, bilirubin, serum albumin, and ascites, and the score range was 5-15 points.
In the Child-Pugh grade, scores of the five factors are summed and evaluated as A if it is less than 7 points, B if it is 7-9, and C if it exceeds 9 points.
Measured: week -6 and 0
Change amount of MELD score
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
The higher the score, the higher the mortality rate.
Measured: week -6 and 0
Change amount of Liver function test
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
Measured: month 0, 1, 3, 6, 9, 12, 18 and 24
Change amount of Fibrosis-4
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
Measured: month 0, 6, 12, 18 and 24
Change amount of FibroScanⓇ
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
Measured: week -6 and 0
Change amount of EQ-5D
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
The higher the score, the higher the quality of life.
Measured: month -1, 6, 12, 18 and 24
Change amount of EQ-VAS
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
The higher the score, the higher the quality of life.
Measured: month -1, 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start19 Apr 2021
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive a single dose of Cellgram-LC or best supportive care, with randomization stratified by Child-Pugh grade (B or C).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmicell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moonyoung Kim, Principal investigator, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689152
- Sponsor's protocol ID
- PMC-P-07
- Acronym
- Cellgram-LC
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04689152
- Acronym / sponsor ID
- Cellgram-LC / PMC-P-07
- Conditions
- Alcoholic Cirrhosis
- Keywords
- Cellgram-LC, Alcoholic Cirrhosis, Liver Cirrhosis, Mesenchymal Stem Cell, Bone Marrow-Derived Mesenchymal Stem Cell, Cell Therapy, Regenerative Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pharmicell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive a single dose of Cellgram-LC or best supportive care, with randomization stratified by Child-Pugh grade (B or C).
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Best Supportive Care (BSC)Best supportive care. |
| Cellgram-LC | Experimental | Biological: Cellgram-LCParticipants receive a single dose of Cellgram-LC through the hepatic artery. |
Who may qualify
- Ages
- 20 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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
- Patients who underwent portal systemic shunting in the jugular vein
- Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening
- Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening
- Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellgram-LCParticipants receive a single injection of 7 × 10^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery. | Biological | Cellgram-LC |
| Best Supportive Care (BSC)Participants receive best supportive care. | Other | Control group |
Primary outcome
Transplant free survival (TFS)
Time frame: For 3 years
Transplant free survival (TFS), the median survival time and 95% confidence interval for each group were presented using the Kaplan-Meier method, and the difference in the survival distribution between the two groups was used as a Cox proportional hazards model corrected for stratification Black.
8 secondary outcomes
Survival rate
Time frame: month 24 and 36
Change amount of Child-Pugh score
Time frame: week -6 and 0
Change amount of MELD score
Time frame: week -6 and 0
Change amount of Liver function test
Time frame: month 0, 1, 3, 6, 9, 12, 18 and 24
Change amount of Fibrosis-4
Time frame: month 0, 6, 12, 18 and 24
Change amount of FibroScanⓇ
Time frame: week -6 and 0
Change amount of EQ-5D
Time frame: month -1, 6, 12, 18 and 24
Change amount of EQ-VAS
Time frame: month -1, 6, 12, 18 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moonyoung Kim principal investigator
Wonju Severance Christian Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cellgram-LC in people with Alcoholic Cirrhosis, run by Pharmicell Co., Ltd. at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YUJEONG KIM (82-2-3496-0137, yjkim@pharmicell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant free survival (TFS) (time frame: For 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.