Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
Cellgram-LC
A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis
1 other identifier
interventional
200
1 country
11
Brief Summary
This phase III clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected hepatic artery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2021
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedStudy Start
First participant enrolled
March 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 2, 2028
March 21, 2024
March 1, 2024
6.4 years
December 21, 2020
March 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
For 3 years
Secondary Outcomes (8)
Survival rate
month 24 and 36
Change amount of Child-Pugh score
week -6 and 0
Change amount of MELD score
week -6 and 0
Change amount of Liver function test
month 0, 1, 3, 6, 9, 12, 18 and 24
Change amount of Fibrosis-4
month 0, 6, 12, 18 and 24
- +3 more secondary outcomes
Other Outcomes (1)
α-fetoprotein test
week -6, month 3, 6, 9, 12, 18, 24
Study Arms (2)
Control group
NO INTERVENTIONBest Supportive care
Injection group: Cellgram-LC
EXPERIMENTALWithin 1 month after extracting bone marrow, directly inject 7X10\^7 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery.
Interventions
Patients will receive single injection of Cellgram-LC(mesenchymal stem cell) hepatic artery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Soonchunhyang University Hospital
Bucheon-si, South Korea
Soonchunhyang University Hospital
Cheonan, South Korea
Gangwon National University Hospital
Chuncheon, South Korea
Hallym Univ. Medical Center
Chuncheon, South Korea
Gangneung Asan Hospital
Gangneung-si, South Korea
Eunpyeong St. Mary's Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Soonchunhyang University Hospital
Seoul, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Yongin Severance Hospital
Yŏngin, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moonyoung Kim
Wonju Severance Christian Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2020
First Posted
December 30, 2020
Study Start
March 2, 2021
Primary Completion (Estimated)
August 2, 2027
Study Completion (Estimated)
January 2, 2028
Last Updated
March 21, 2024
Record last verified: 2024-03