Other
Conditions
Interventions
observation group:N/A
Sponsors
Liver Biotechnology (Shenzhen) Co., LTD
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. A informed consent: to be able to provide written informed consent before participating in the study, including compliance with the requirements and restrictions listed in the informed consent. The donor must be able to read, understand, and write the materials required for the study; 2. Age and weight: 2 years to 65 years old, weighing at least 10kg; 3. Gender: male or female; 4. HBV: negative for nucleic acid; 5. HIV: nucleic acid negative; 6. HCV: nucleic acid negative; 7. Gonorrhea: negative for nucleic acid; 8. Syphilis: nucleic acid negative; 9. Emerging infectious diseases: negative for nucleic acid; 10. Tissue canceration in liver group: negative.
Exclusion criteria
Exclusion criteria: 1. Clinical significance was defined as a disease/condition that, according to the investigator's assessment, would pose a safety risk to the donor during study participation or that would worsen during the study to affect the efficacy or safety analysis; 2. Malignancy: existing malignancy or a previous history of cancer in remission for less than 12 months prior to screening (donors whose local skin cancer has been removed and cured are not excluded); 3. Liver disease: current unstable liver disease or biliary tract disease assessed by the investigator based on ascites, encephalopathy, clotting disorders, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis; 4. other comorbidities: endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, liver, hematological, or other system abnormalities that are known to have clinical significance and are not controlled with standard care; 5. Existing malignancies, except basal and squamous skin cancers; 6. liver parasitic infection: visit 1 donor known to have parasitic infection in the previous 6 months; 7. Alcohol/drug abuse: a history (or suspected) of alcohol or drug abuse within the first 2 years of visit; 8. Immunodeficiency: known immunodeficiency; 9. Compliance: donors with known evidence of noncompliance with controlled medication and/or failure to follow physician recommendations; 10. The validity of informed consent is questionable: a history of mental illness, mental retardation, poor motivation, or other medical conditions that would limit the validity of informed consent for participation in the study; 11. Re-screening of donors is permitted only after approval by a medical examiner.
Countries
China
Contacts
Public ContactZhou Ming
Liver Biotechnology (Shenzhen) Co., LTD
Outcome results
None listed