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NCT Number: NCT04357600

Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B

The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.

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Key information

Conditions

Liver Cirrhoses

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cipto Mangunkusumo hospital

Jakarta, DKI Jakarta, Indonesia

About this study

The study is investigating the effect and safety of stem cells therapy in patients with liver cirrhosis that is specifically caused by Hepatitis B infection, the participants will be chosen based on inclusive and exclusive criteria to ensure the eligibility of the patients for this study. The patients will be given therapy in the form of allogeneic mesenchymal stem cells transplantation, the stem cells in this study were provided from Prodia Stem Cell Indonesia (ProSTEM). The stem cells being will also be subjected to certain criteria to ensure the utmost safety. The data of this study will be derived from the observation results of the patients' liver damage status in weeks 4, 6 and 12. Aside from that, hemodynamic will be conducted as a part of the observation

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with decompensated cirrhosis (Child-Pugh B) caused by hepatitis B infection (Cirrhosis is evidenced by the results of ultrasonography examination and chronic hepatitis B infection is found in patients who are taking hepatitis B drugs)

Exclusion criteria

  • Patients who refuse to participate in research
  • Having malignancies disease, both liver malignancies or other malignancies
  • Having another co-infections such as hepatitis C and Human Immunodeficiency Virus (HIV).
  • Pregnant or lactation patients as evidenced by positive pregnancy test results
  • Having complications disease such as diabetes mellitus, severe heart disease, kidney disease, and respiratory disease
  • Having the case of alcohol dependence and NASH
  • Patients who have undergone transplantation and other stem cell therapy

Treatment and study plan

Allogeneic Umbilical Cord Mesenchymal Stem Cell

Biological

All research samples will be treated by Intravenous injection of allogeneic mesenchymal stem cells and hemodynamic observation will be done for 24 hours after treated. Periodic post-treatment observation will be done on 1st month, 3rd month, and 6th month after therapy. The Independent variable in this research is Child-Pugh B Cirrhosis caused by Hepatitis B, while the dependent variable is the degree of liver function damage consisting of an examination of liver function, Child-Pugh score, and MELD score.

Primary outcomes

  1. Child Pugh Score

    Time frame: 1 month after injection

    a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.

  2. Child Pugh Score

    Time frame: 3 months after injection

    a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.

  3. Child Pugh Score

    Time frame: 6 months after injection

    a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.

  4. Examination of liver function

    Time frame: 1 month after injection

    assessed from SGOT and SGPT values in laboratory tests result

  5. Examination of liver function

    Time frame: 3 months after injection

    assessed from SGOT and SGPT values in laboratory tests result

  6. Examination of liver function

    Time frame: 6 months after injection

    assessed from SGOT and SGPT values in laboratory tests result

  7. MELD Score

    Time frame: 1 month after injection

    a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.

  8. MELD Score

    Time frame: 3 months after injection

    a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.

  9. MELD Score

    Time frame: 6 months

    a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2020
Registry last updated
Feb 25, 2026

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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