Clinical research for treatment of liver cirrhosis by human allogeneic hepatic cells

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032383

Enrollment

Unknown

Registered

2020-04-27

Start date

2020-05-01

Completion date

Unknown

Last updated

2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cirrhosis

Interventions

Low-dose group:Transfusion with high dose of human hepatic cells

Medium-dose group:Transfusion with medium dose of human hepatic cells

High-dose group:Transfusion with high dose of human hepatic cells

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, both men and women; 2. Clinical diagnosis of liver cirrhosis, Child-Pugh score 5-7 points; 3. ECOG physical status score 0-1 or KPS score> 70 points; 4. Have a safe puncture path for percutaneous liver biopsy; 5. Have safe vascular access via transhepatic artery intubation; 6. No severe coagulopathy or hemorrhagic constitution (such as hemophilia); 7. Patients with hepatitis B or C cirrhosis are receiving standardized antiviral treatment; 8. Ability to understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. With liver cancer or other malignant tumors; 2. Patients who cannot cooperate; 3. The prothrombin time (PT) exceeds the upper limit of the normal control by more than 3 to 5 seconds; 4. International standardized ratio (INR) <=1.5; 5. PLT < 60x106^9/L; 6. Recently used (last 7 days) anticoagulant or antiplatelet drugs; 7. Recently (within 4 weeks) upper gastrointestinal bleeding or spontaneous peritonitis; 8. Moderate or massive peritoneal effusion; 9. Severe dysfunction of important organs such as heart and lungs; 10. Pregnant or lactating women; 11. HIV positive; 12. Any uncontrollable active infection; 13. The investigator assesses that the patient is unable or unwilling to comply with the requirements of the study protocol.

Design outcomes

Primary

Measure	Time frame
Liver function (serum albumin ALB, alanine aminotransferase ALT, aspartate aminotransferase AST, cholinesterase CHE, total bilirubin TBIL, direct bilirubin DB, serum cholesterol CHO, prothrombin activity PTA, antithrombin AT);	—

Secondary

Measure	Time frame
Liver ultrasound imaging;Liver enhanced MRI / CT;Liver fibrosis hematological indicators (type III procollagen, type IV collagen, laminin and hyaluronidase;Liver biopsy histopathology;	—

Countries

China

Contacts

Public ContactXia Qiang

Renji Hospital, Shanghai Jiaotong University School of Medicine

Xiaqiang@medmail.com.cn+86 13661889035

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026