Phase
Condition
Hyponatremia
Scar Tissue
Hepatic Fibrosis
Treatment
Cellgram-LC
Clinical Study ID
Ages 20-71 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- At the time of screening, 19 or 70 years
- Patients diagnosed with alcoholic cirrhosis by combining alcohol history, imaging andpathological examination results, and clinical symptoms at screening, and belonging toChild-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 thehepatic artery at the judgment of the examiner
- In the case of women of childbearing potential, a person who was confirmed negative inthe pregnancy test at screening and agreed to use contraception* by the methodpermitted 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 clinicaltrial
Exclusion
Exclusion Criteria:
- 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 arecurrently undergoing chemotherapy or those whose hepatocellular carcinoma has beenconfirmed by screening tests
- Patients who underwent portal systemic shunting in the jugular vein
- Patients with alcohol consumption or hepatotoxic drugs within 6 months prior toscreening
- Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severeinfections for at least 1 month of screening
- Those who have major surgical operations, long-term biopsy, or significant trauma asjudged by the investigator within 3 months before screening
- Those whose history of gastrointestinal bleeding is confirmed within 10 days ofscreening
- Those whose medical history or accompanying diseases following the screening time isconfirmed
- If you have not been diagnosed with a malignant blood disease (acute myelogenousleukemia, 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 andautoimmune hepatitis, etc.), weak liver toxicity, non-alcoholic fatty liverdisease , 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 1.5times the upper limit of normal)
- Acute or chronic infection requiring systemic treatment
- Severe coagulation disorder (if the tester judges it as a severe coagulationdisorder or one of the following 1 to 3; 1. bleeding predisposition, 2.coagulation, 3. platelet≤50,000/mm3 and INR≥1.5)
- 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
- Pregnant or lactating women
- Those with substance abuse experience within 1 year before screening
- Those who participated in other clinical trials within one month before screening andadministered (or applied) clinical trial drugs (or medical devices)
- Those who previously participated in clinical trials related to cell therapy
- Patients judged to be inappropriate to participate in this clinical trial due tocomplications, etc., when judged by the investigator before screening or registration
Study Design
Study Description
Connect with a study center
Soonchunhyang University Hospital
Bucheon,
Korea, Republic ofActive - Recruiting
Soonchunhyang University Hospital
Cheonan,
Korea, Republic ofActive - Recruiting
Gangwon National University Hospital
ChunCheon,
Korea, Republic ofActive - Recruiting
Hallym Univ. Medical Center
ChunCheon,
Korea, Republic ofActive - Recruiting
Gangneung Asan Hospital
Gangneung-si,
Korea, Republic ofActive - Recruiting
Eunpyeong St. Mary's Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Korea University Anam Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Soonchunhyang University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Wonju Severance Christian Hospital
Wonju,
Korea, Republic ofActive - Recruiting
Yongin Severance Hospital
Yongin,
Korea, Republic ofActive - Recruiting
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