Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT05155657
Eligibility Criteria:
Inclusion Criteria:
1. Age 18\~60 years old;
2. The subject was diagnosed as decompensated alcoholic liver cirrhosis, according to the Guidelines for the Diagnosis and Treatment of Liver Cirrhosis and the Guidelines for the Prevention and Treatment of Alcoholic Liver Disease (2018);
3. The subject was previously diagnosed but treatment is ineffective;
4. Liver function was in child Pugh grade A or MELD score \< 12;
5. Intermittent albumin supplementation and diuretic treatment are required;
6. The subject's Albumin level is less than 35g/L, total bilirubin is smaller than 10 times of the upper limit of normal value (hepatocyte hepatitis), or smaller than 15 times of the upper limit of normal value (cholestatic hepatitis or hepatocyte combined with cholestatic hepatitis), prothrombin activity is over 40% (grade II or lower hepatic encephalopathy has been controlled);
7. No history of gastrointestinal hemorrhage in the past month;
8. The subject understand and voluntarily sign the informed consent.
Exclusion Criteria:
1. The subject is allergic physique, with a history of drug or food allergies, especially those who are allergic to umbilical cord mesenchymal stem cells and any components in excipients;
2. The subject suffer acute attack of gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome or infection;
3. The subject suffer systemic infection or severe infection during screening;
4. Abnormal laboratory examinations results, including blood routine: peripheral blood white blood cell count \<2.0×10\^9/L or \>12×10\^9/L, hemoglobin (Hb) is less than 70% lower limit of the normal value, platelets \<50×10\^9/L ; Liver function: ALT or AST\> 5 times the upper limit of normal; Renal function: Serum Creatinine (sCr)\> 1.5 times the upper limit of normal; in case of abnormality, test shall be repeated;
5. Those who were positive for Hepatitis B surface Antigen (HBsAg) or Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody or syphilis antibody during screening;
6. Subjects suffer from serious, progressive, or uncontrolled diseases of important organs (including cardiovascular system, liver, lung and kidney), and other autoimmune diseases, malignant tumors, or a history of previous tumors, as well as other diseases that researchers believe that they are not suitable to participate in this clinical study.
7. Subject who has received stem cell therapy within 6 months before the screening;
8. Subject who has received biotherapy or participated in other clinical studies within 3 months before screening;
9. Female subjects who are pregnant, lactating, or premenopausal subject who failed to take medically approved non-drug contraceptive measures (such as intrauterine device, condom, female sterilization) during treatment and within 6 months after the treatment; or have a pregnancy plan within 6 months after the end of the study;
10. Male subjects who fail to take medically approved non-drug contraceptive measures (such as male sterilization or condom) during the treatment period and within 6 months after the end of the treatment;
11. Other factors that the researchers believe are not suitable for entering the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05155657
Study Brief:
Protocol Section:
NCT05155657