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

NCT04357600 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: CT/LC/01/2018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cirrhoses

Keywords

Allogeneic Mesenchymal Stem Cell; Umbilical Cord Mesenchymal Stem Cell; liver cirrhosis due to type B hepatitis

Outcome Measures

Primary Outcomes (9)

• Child Pugh Score

  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.

  1 month after injection

• Child Pugh Score

  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 months after injection

• Child Pugh Score

  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.

  6 months after injection

• Examination of liver function

  assessed from SGOT and SGPT values in laboratory tests result

  1 month after injection

• Examination of liver function

  assessed from SGOT and SGPT values in laboratory tests result

  3 months after injection

• Examination of liver function

  assessed from SGOT and SGPT values in laboratory tests result

  6 months after injection

• MELD Score

  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.

  1 month after injection

• MELD Score

  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.

  3 months after injection

• MELD Score

  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.

  6 months

Study Arms (1)

intravenous injection of UC-MSC

EXPERIMENTAL

The dosage of the intravenous route is 100 million MSCs for each subject.

Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell

Interventions

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.

intravenous injection of UC-MSC

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• PT. Prodia Stem Cell Indonesia: lead

Study Sites (1)

Cipto Mangunkusumo hospital

Jakarta, DKI Jakarta, Indonesia

Location

Study Officials

• Chyntia O Jasirwan, PhD

  Cipto Mangunkusumo Hospital, Jakarta

  PRINCIPAL INVESTIGATOR

• Rima Haifa, B.Sc

  Prodia Stem Cell Indonesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study model is considered as a single group assignment since all the participants are being administered with the same treatment.

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: April 22, 2020
• Study Start: May 17, 2018
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): December 20, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

ID (1)