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A prospective clinical controlled study evaluating the effectiveness and safety of umbilical cord mesenchymal stem cells in the treatment ofdecompensated liver cirrhosis

A prospective clinical controlled study evaluating the effectiveness and safety of umbilical cord mesenchymal stem cells in the treatment of decompensated liver cirrhosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047110
Enrollment
Unknown
Registered
2021-06-08
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-01-24

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

Conditions

decompensated liver cirrhosis

Interventions

umbilical cord mesenchymal stem cells treatment group:umbilical cord mesenchymal stem cells and given conventional drug treatment
control group :given conventional drug treatment.

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Clinically diagnosed as a patient with decompensated liver cirrhosis; 2.Aged 18 to 65 years; 3.The HBV/HCV viral load has been lower than the detection level for more than 6 months. Child-Pugh B or C or MELD score > 10; 4.For other causes of liver cirrhosis,the liver function is decompensated; 5.After standard medical treatment for at least 6 months, the liver function continued to deteriorate with the at least one episode of the following complications:massive ascites, spontaneous bacterial peritonitis, variceal bleeding and hepatic encephalopathy; 6.Need intermittent albumin infusion and diuretic treatment; 7.At the time of stem cell treatment, the albumin should be 30% (prothrombin time = 7 points; 8.No active variceall bleeding in the past 4 weeks, and the the rebleeding risk is not very high before treatment; 9.Not able to received orthotopic liver transplantation; 10.Agree to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Malignant tumors of the liver or other organs or any history of malignant tumors; 2.Complicated with variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, liver and kidney syndrome, and acute infection at the time of treatment; 3.Patients with severe heart, lung, kidney or blood system diseases; 4.Pregnant or breastfeeding women; 5.Allergic constitution; 6.People who have a history of alcohol or drug abuse and have not compleately quited; 7.Participated in other clinical trials within 3 months; 8.Any reasons that the investigators believe that patients should not participate in other situations in this study.

Design outcomes

Primary

MeasureTime frame
The 2-year overall survival rate;Overall survival;

Secondary

MeasureTime frame
Liver function;Model for end-stage liver disease;Child-pugh score;Karnofsky functional status score improvement;

Countries

China

Contacts

Public ContactZhu Yueyong

The First Affiliated Hospital of Fujian Medical University

ezhu066@sina.com+86 13950233535

Outcome results

None listed

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