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

Ki vehet részt

• 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

Ki nem vehet részt

• Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening
• Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months 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
• 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
• Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening
• Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening
• 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
• 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)
• Patients who underwent portal systemic shunting in the jugular vein
• Pregnant or lactating women
• Those with substance abuse experience within 1 year before screening
• Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration