Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis

NCT04689152 | Recruiting Phase 3

• 1 other identifier: PMC-P-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

Brief 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 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

Keywords

Cellgram-LC; Alcoholic Cirrhosis; Liver Cirrhosis; Mesenchymal Stem Cell; Bone Marrow-Derived Mesenchymal Stem Cell; Cell Therapy; Regenerative Medicine

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

Other Outcomes (1)

• α-fetoprotein test

  week -6, month 3, 6, 9, 12, 18, 24

Study Arms (2)

Control group

ACTIVE COMPARATOR

Best supportive care.

Other: Best Supportive Care (BSC)

Cellgram-LC

EXPERIMENTAL

Participants receive a single dose of Cellgram-LC through the hepatic artery.

Biological: Cellgram-LC

Interventions

Cellgram-LC BIOLOGICAL

Participants receive a single injection of 7 × 10\^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.

Cellgram-LC

Best Supportive Care (BSC) OTHER

Participants receive best supportive care.

Control group

Eligibility Criteria

• Age: 20 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (15)

Korea University Ansan Hospital

Ansan, South Korea

RECRUITING

Soonchunhyang University Hospital

Bucheon-si, South Korea

RECRUITING

Soonchunhyang University Hospital

Cheonan, South Korea

TERMINATED

Gangwon National University Hospital

Chuncheon, South Korea

TERMINATED

Hallym Univ. Medical Center

Chuncheon, South Korea

RECRUITING

Gangneung Asan Hospital

Gangneung-si, South Korea

RECRUITING

Eunpyeong St. Mary's Hospital

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

NOT YET RECRUITING

Soonchunhyang University Hospital

Seoul, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

Yongin Severance Hospital

Yongin, South Korea

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Moonyoung Kim

  Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YUJEONG KIM

CONTACT

82-2-3496-0137; yjkim@pharmicell.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study in which investigators and participants are aware of the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 30, 2020
• Study Start: April 19, 2021
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (15)