Evaluating Cellgram-LC for Alcoholic Cirrhosis Treatment

A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis

This study is testing whether a new treatment using stem cells can help people with alcoholic cirrhosis feel better and improve their liver health.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 20 Years to 71 Years
• Sex: All
• Sponsor: Pharmicell Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 11 sites (Bucheon-si and 10 other locations)
• Trial ID: NCT04689152 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial aims to assess the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) administered via hepatic artery in patients with alcoholic cirrhosis. Participants will receive a single dose of Cellgram-LC, and their health will be monitored for 60 months to evaluate treatment outcomes. The study focuses on patients diagnosed with Child-Pugh grade B or C alcoholic cirrhosis, ensuring a thorough assessment of the intervention's impact on liver function and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 to 70 with a diagnosis of alcoholic cirrhosis classified as Child-Pugh grade B or C.

Not a fit: Patients with a history of solid cancer or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver function and quality of life for patients suffering from alcoholic cirrhosis.

How similar studies have performed: While there have been studies on stem cell therapies for liver diseases, this specific approach using Cellgram-LC in alcoholic cirrhosis is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. At the time of screening, 19 or 70 years
2. 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)
3. Those whose survival period is more than 1 year when judged by the tester
4. Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner
5. 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
6. Those who can conduct clinical trials according to the clinical trial protocol
7. A person who has consented in writing to voluntarily participate in this clinical trial

Exclusion Criteria:

1. 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
2. Patients who underwent portal systemic shunting in the jugular vein
3. Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening
4. Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening
5. Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening
6. Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening
7. 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)
8. serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor
9. Patients unable to collect bone marrow due to bone marrow disease
10. Those with a history of gentamicin hypersensitivity reaction
11. Pregnant or lactating women
12. Those with substance abuse experience within 1 year before screening
13. Those who participated in other clinical trials within one month before screening and administered (or applied) clinical trial drugs (or medical devices)
14. Those who previously participated in clinical trials related to cell therapy
15. Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration

Where this trial is running

Bucheon-si and 10 other locations

• Soonchunhyang University Hospital — Bucheon-si, South Korea (Recruiting)
• Soonchunhyang University Hospital — Cheonan, South Korea (Recruiting)
• Gangwon National University Hospital — Chuncheon, South Korea (Recruiting)
• 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)
• Korea University Anam Hospital — Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Soonchunhyang University Hospital — Seoul, South Korea (Recruiting)
• Wonju Severance Christian Hospital — Wŏnju, South Korea (Recruiting)
• Yongin Severance Hospital — Yŏngin, South Korea (Recruiting)

Study contacts

• Principal investigator: Moonyoung Kim — Wonju Severance Christian Hospital
• Study coordinator: Jiyeoun Jeong

Conditions Alcoholic Cirrhosis