Clinical Study of hUC-MSCs Treating Decompensated Liver Cirrhosis With HBV (CS-hUC-MSCs)

Zhongnan Hospital

Status and phase: Completed; Early Phase 1

Conditions: HBV

Treatments: Biological: hUCMSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT05442437

03

Details and patient eligibility

About

The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV.

Full description

Investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with HBV, dividing them into 3 group：1) low-dose group: 100mL with 2.5×10^7 cells；2) medium-dose group: 100mL with 5.0×10^7 cells；3) high-dose group: 100mL with 1.0×10^8 cells. Each group contains 8 patients. Investigators treat the participants with human umbilical cord mesenchymal stem cells via venous transfusion. First investigators arrange a whole test for participants, such as vital sign examination, laboratory test, ECG, CT, MRI, ultrasound etc. Investigators screen these patients with a complete eligibility criteria. Then investigators proceed the therapy in the 1st, 8th and 15th day. There are 8 times of follow-up visit for these patients, 4 times of those are proceeded during the hospitalization, while other 4 times happens after the discharge. The follow-up visit includes vital sign examination, laboratory test, ECG, CT, MRI, ultrasound, Child-Pugh grade, MELD grade, SF-36 test. These follow-up visit last 24 weeks since the first treatment. After that, investigators also arrange a survival visit through phone or clinic each 6 months, lasting another 1.5 years. The main object of this research is investigating the survival rate, promotion of the liver function, improvement of health, safety of hUC-MSCs, tolerability of patients, for exploring a new way for the therapy of decompensated liver cirrhosis with HBV.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 18 and 65 (including 18 and 65), regardless of gender;
• Decompensated stage of viral hepatitis B cirrhosis;
• The effect of conventional medical treatment is not good, and the condition is repeated;
• ALB < 35g/L, TBIL < 170μmol/L, INR > 30%, Child-pugh score ≥7; MELD score ≤15;
• Hgb > 70g/L, PLT > 3×109/L;
• Unconditional acceptance for liver transplantation; 7）Participate in the clinical study voluntarily, cooperate with doctors to carry out the study, and sign informed consent.

Exclusion criteria

• With spontaneous peritonitis or other serious infection;
• Patients with hepatorenal syndrome;
• Severe hepatic encephalopathy, massive hemorrhage of digestive tract or varicose 4. vein in recent 1 month;
• Portal vein thrombosis; Complicated with serious diseases of heart, lung, kidney,
• blood and endocrine system;
• HIV positive;
• Positive autoantibodies related to autoimmune liver disease;
• Presence of liver or any type of malignant tumor;
• Pregnant women, breast-feeding women or those with recent birth plans;
• Those who have a history of alcohol and drug abuse and failed to get rid of it effectively;
• Participated in other clinical trials within 3 months prior to enrollment;
• Participated in clinical research on stem cells;
• Unwillingness to sign informed consent;
• Other conditions that the investigator considers inappropriate for patients to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Low-dose group

Experimental group

Description:

100mL human umbilical cord mesenchymal stem cell preparation, containing 2.5×10\^7 cells.

Treatment:

Biological: hUCMSCs

medium-dose group

Experimental group

Description:

100mL human umbilical cord mesenchymal stem cell preparation, containing 5.0×10\^7 cells.

Treatment:

Biological: hUCMSCs

High-dose group

Experimental group

Description:

100mL human umbilical cord mesenchymal stem cell preparation, containing 1.0×10\^8 cells.

Treatment:

Biological: hUCMSCs