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Completed

NCT Number: NCT05442437

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

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.

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Key information

Conditions

HBV

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Serum albumin in g/L

    Time frame: 24 weeks

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

  2. alanine aminotransferase in U/L

    Time frame: 24 weeks

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

  3. aspartate aminotransferase in U/L

    Time frame: 24 weeks

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

  4. cholinesterase in U/L

    Time frame: 24 weeks

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

  5. Total bilirubin in μmol/L

    Time frame: 24 weeks

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

  6. Direct bilirubin in μmol/L

    Time frame: 24 weeks

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

  7. Serum cholesterol in mmol/L

    Time frame: 24 weeks

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

  8. Prothrombin activity in percentage

    Time frame: 24 weeks

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

  9. Antithrombin in mg/L

    Time frame: 24 weeks

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

Secondary outcomes

  1. survival rate

    Time frame: 2 years

    survival rate after 2 years since the first therapy

  2. Child-Pugh grade

    Time frame: 24 weeks

    Child-Pugh grade is defined according to hepatic encephalopathy, ascites，serum albumin, total bilirubin, prothrombin time. Score 5-6 is grade A. Score 7-9 is grade B. Score 10-15 is grade C.

    We compare the Child-Pugh grade in first day, 4th, 8th, 12th and 24th week, to describe its tendency.

  3. Rate of weight change

    Time frame: 24 weeks

    We compare the weight in first day, 4th, 8th, 12th and 24th week, to describe its tendency.

  4. Ascites

    Time frame: 24 weeks

    We test the ascites via ultrasound, CT and MRI. We classify the ascite level into none, low and high.

    We compare the Child-Pugh grade in first day, 4th, 8th, 12th and 24th week, to describe its tendency.

  5. clinical symptoms

    Time frame: 24 weeks

    Including lower limb edema, hematemesis, jaundice, fatigue, poor appetite. We compare these symptoms in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  6. Th1 cells in percentage

    Time frame: 24 weeks

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

  7. Th2 cells in percentage

    Time frame: 24 weeks

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

  8. Natural killer T cells in percentage

    Time frame: 24 weeks

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

  9. Interleukin-1β cells in pg/mL

    Time frame: 24 weeks

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

  10. Interleukin-4 cells in pg/mL

    Time frame: 24 weeks

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

  11. Interleukin-6 cells in pg/mL

    Time frame: 24 weeks

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

  12. Interleukin-8 cells in pg/mL

    Time frame: 24 weeks

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

  13. Interleukin-12 cells in pg/mL

    Time frame: 24 weeks

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

  14. Interleukin-15 cells in pg/mL

    Time frame: 24 weeks

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

  15. Interleukin-17A cells in pg/mL

    Time frame: 24 weeks

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

  16. Medical images

    Time frame: 24 weeks

    Ultrasound in first day, 4th, 8th, 12th and 24th; enhanced CT scanning and/or MRI-Primovist scanning in first day, 12th week and 24th week.

  17. The Medical outcomes study 36-item Short Form Health Survay scale (SF-36 scale)

    Time frame: 24 weeks

    SF-36 scale is a measurement for patients' living quality. The scores contain 8 parts, including physical functioning, role-physica, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Conversion score=(actual score-minimum score in this part)/(maximum score in this part-minimum score in this part)*100. Score of each part range from 0 to 100. The higher score means more healthy. We proceed SF-36 test in 12th week and 24th week

  18. MELD score

    Time frame: 24 weeks

    MELD=3.78*Ln(total bilirubin mg/dL)+11.2*Ln(INR)+9.57*Ln(serum creatine mg/dL)+6.43 (for HBV patient) We compare MELD score in first day, 4th, 8th, 12th and 24th week, to describe its tendency.

Other outcomes

  1. Adverse events

    Time frame: 24 weeks

    Including infusion reaction, anaphylaxis, hemolysis, acute liver failure, acute kidney failure. We observe whether participants shows these adverse event during the first whole 2 weeks and 4th, 8th, 12th and 24th weeks

  2. Vital signs

    Time frame: 24 weeks

    body temperature, pulse, respiration, blood pressure. We measure the vital signs in first day, 1st , 2nd, 3rd, 4th, 8th, 12th and 24th week.

  3. Physical examination

    Time frame: 24 weeks

    Including jaundice in skin or sclera, liver palms, spider angioma, abdominal tenderness, borborygms, shifting dullness. We proceed the physical examination in first day, 1st , 2nd, 3rd, 4th, 8th, 12th and 24th week.

  4. Leukocyte in 10^9/L

    Time frame: 24 weeks

    We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  5. Hemoglobin in g/L

    Time frame: 24 weeks

    We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  6. Thrombocyte in 10^9/L

    Time frame: 24 weeks

    We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  7. Serum creatine in

    Time frame: 24 weeks

    We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  8. Serum creatine in μmol/L

    Time frame: 24 weeks

    We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  9. Serum urea nitrogen in mmol/L

    Time frame: 24 weeks

    We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  10. Alpha-fetoprotein in ng/mL

    Time frame: 24 weeks

    We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.

  11. Electrocardiogram of 12 leads

    Time frame: 24 weeks

    Including lead I, II, III, AVL, AVF, AVR, V1 to V6. We record the diagnosis of the ECG, not a specific parameter. We test it in first day, 4th, 8th, 12th and 24th week.

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells for Treating Decompensated Liver Cirrhosis Associated With HBV

Acronym: CS-hUC-MSCs

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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