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Clinical Trials in South Korea / NCT04689152
Recruiting Phase 3

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

NCT04689152 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2021-04-19
Last updated
2026-09-21

Condition(s) studied

Alcoholic Cirrhosis

Investigational drug(s) / intervention(s)

Cellgram-LCBest Supportive Care (BSC)

Cellgram-LC: 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): Participants receive best supportive care.

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
71 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
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

More Pharmicell Co., Ltd. trials in South Korea

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04689152 on ClinicalTrials.gov ↗ ← All trials in South Korea