Skip to content

Clinical study on the effect of umbilical cord mesenchymal stem cells on liver regeneration in patients with decompensated hepatitis b cirrhosis

Clinical study on the effect of umbilical cord mesenchymal stem cells on liver regeneration in patients with decompensated hepatitis b cirrhosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039312
Enrollment
Unknown
Registered
2020-10-23
Start date
2020-04-01
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

Decompensated stage of hepatitis B cirrhosis

Interventions

portal vein group:Conventional therapy, combined with portal vein infusion of stem cells
control group:conventional therapy
peripheral venous group:conventional treatment, combined with peripheral intravenous infusion of stem cells
hepatic artery group:conventional therapy, combined with hepatic arterial infusion of stem cells

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. For those aged 18 or above and 60 or below, there is no gender limit; 2. Patients diagnosed as decompensated hepatitis B cirrhosis; 3. Patients with effective antiviral therapy; 4. The patients with poor effect of routine medical treatment have recurrent disease; 5. Patients who refused liver transplantation; 6. The patients who voluntarily participate in the clinical study can cooperate with the doctor to carry out the study and sign the informed consent; 7. ALB 50 x 10 ^ 9/L (if there is no obvious bleeding tendency, patients with PLT of 30-50 x 10 ^9 /L can also be included), child Pugh score >= 7, MELD score 70g / L.

Exclusion criteria

Exclusion criteria: 1. Patients with history of liver or any other type of malignant tumor; 2. Patients with history of alcoholic hepatitis, drug-induced liver damage, fatty liver, other viral hepatitis, cytomegalovirus infection, Epstein Barr virus infection, autoimmune liver disease, confirmed hereditary liver disease and other diseases that may lead to liver cirrhosis or liver dysfunction; 3. Patients with severe complications (gastrointestinal bleeding, hepatic coma, peritonitis, severe infection, hepatorenal syndrome) within 1 month; 4. Patients with portal vein thrombosis, cavernous transformation of portal vein, Budd Chiari syndrome and other portal vein diseases that are not suitable for stem cell infusion; 5. Patients with biliary obstruction; 6. Patients with history of splenectomy and devascularization, portosystemic shunt and tips; 7. Patients who received immunosuppressant and immunopotentiator treatment within 3 months; 8. Patients who have received blood transfusion and other blood products within one month; 9. Patients with history of major organ transplantation or severe diseases of heart, lung, kidney, blood, endocrine and other systems; 10. Patients with severe mental history, especially those with depression; 11. Patients with unstable vital signs; 12. Patients with high allergic constitution or severe allergic history; 13. HIV positive patients; 14. Patients taking drugs or receiving methadone treatment within one year before the start of the trial; 15. Pregnant women, lactating women or objects with family planning in the near future; 16. Those who are unable or unwilling to sign the informed consent, or who do not comply with the test requirements; 17. Subjects who participated in other clinical trials within 3 months before enrollment; 18. Very few objects with high expectations or unrealistic requirements; 19. Other conditions considered by the researchers that the patients should not participate in this study.

Design outcomes

Primary

MeasureTime frame
glutamic-pyruvic transaminase;glutamic oxalacetic transaminase;albumin;total bilirubin;prothrombin activity;platelets;

Secondary

MeasureTime frame
alkaline phosphatase;Gamma-glutamyl transpeptidase;total bile acid;cholinesterase;liver volume;

Countries

China

Contacts

Public ContactXun Li

The First Hospital of Lanzhou University

lxdr21@126.com+86 13993038612

Outcome results

None listed

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