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

NCT05442437 | Completed Early Phase 1

• 1 other identifier: 03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HBV

Outcome Measures

Primary Outcomes (9)

• Serum albumin in g/L

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

• alanine aminotransferase in U/L

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

• aspartate aminotransferase in U/L

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

• cholinesterase in U/L

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

• Total bilirubin in μmol/L

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

• Direct bilirubin in μmol/L

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

• Serum cholesterol in mmol/L

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

• Prothrombin activity in percentage

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

• Antithrombin in mg/L

  We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  24 weeks

Secondary Outcomes (18)

• survival rate

  2 years

• Child-Pugh grade

  24 weeks

• Rate of weight change

  24 weeks

• Ascites

  24 weeks

• clinical symptoms

  24 weeks

Other Outcomes (11)

• Adverse events

  24 weeks

• Vital signs

  24 weeks

• Physical examination

  24 weeks

Study Arms (3)

Low-dose group

EXPERIMENTAL

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

Biological: hUCMSCs

medium-dose group

EXPERIMENTAL

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

Biological: hUCMSCs

High-dose group

EXPERIMENTAL

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

Biological: hUCMSCs

Interventions

hUCMSCs BIOLOGICAL

Human umbilical cord mesenchymal stem cell preparation, 100ml/ bag, containing 2.5×107 cells, 5.0×107 cells, 1.0 x 108 cells

High-dose group; Low-dose group; medium-dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We allocate 24 participants into 3 group, low-dose, medium-dose and high-dose group. It is going to proceeded sequential from low-dose group to high-dose group. Next group is allowed to be started only the last group has been finished. 1. Low-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 2.5×10\^7 cells; 2. medium-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 5.0×10\^7 cells; 3. High-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 1.0×10\^8 cells

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: July 5, 2022
• Study Start: September 8, 2019
• Primary Completion: July 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 1, 2023

Record last verified: 2021-12

Locations

CN (1)