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The efficacy of intravenous umbilical cord blood mononuclear cells (UCB-MNCs) in patients with decompensated cirrhosis

The efficacy of intravenous umbilical cord blood mononuclear cells (UCB-MNCs) in patients with decompensated cirrhosis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060815
Enrollment
Unknown
Registered
2022-06-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Decompensated stage of cirrhosis

Interventions

MNCs treatment group:Human cord blood mononuclear cells were intravenously transfused according to body weight, once a week, 4 times in total, 2×106/kg/ time
control group:conventional therapy

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Definite diagnostic basis of decompensated stage of cirrhosis. The diagnosis of cirrhosis can be based on the following criteria :(1) definite histological, endoscopic or imaging evidence of cirrhosis; (2) Patients without histological, endoscopic or imaging examination should meet 2 of the following 4 criteria: (1)Platelet count & LT; 100×10^9/L, no other reasons can be explained; (2)albumin = 7 and MELD score 30%, platelet > 50×10^9/L(if there is no obvious bleeding tendency, PLT can be included in 30-50×10^9/L patients), hemoglobin > 70g/L; 9.Female subjects of childbearing age agreed to use contraception throughout the study period.

Exclusion criteria

Exclusion criteria: 1.complicated with liver or any other type of malignant tumor; 2.patients with severe complications within 1 month (digestive tract hemorrhage/acute hemorrhage, hepatic encephalopathy (stage III-IV), severe/acute infection); 3.those who have received immunosuppressant or immunobooster treatment within 3 months; 4.those who have received blood transfusion or other blood products within 1 month; 5.Major organ transplant history or serious diseases of heart, lung, kidney, blood, endocrine and other systems; 6.a history of severe mental illness, especially depression; 7.Patients with unstable vital signs; 8.Patients with poor physical condition who cannot tolerate cell transplantation; 9.highly allergic or have a history of severe allergies; 10.HIV-positive persons; 11.those who used drugs or received methadone treatment within 1 year prior to the start of the study; 12.those who have a history of alcohol and drug abuse and failed to effectively quit; 13.Participated in other clinical trials within 3 months prior to enrollment; 14.pregnant women, breast-feeding women or those with recent birth plans; 15.those who are unable or unwilling to sign the informed consent or fail to comply with the test requirements; 16.a few excessively high expectations or unrealistic demands; 17.Other conditions that the investigator considers inappropriate for patients to participate in this study.

Design outcomes

Primary

MeasureTime frame
The Child - Pugh score;MELD score;Laboratory indicators, clinical symptoms and signs;Sf-36 scale score;

Secondary

MeasureTime frame
Imaging examination and endoscopic evaluation;Body composition related indicators;

Countries

China

Contacts

Public ContactXue Jing
jingxue@qdu.edu.cn+86 18661807575

Outcome results

None listed

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