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

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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhoses
• Intervention / Treatment: Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Chyntia O Jasirwan, PhD; Phone Number: 08121058683; Email: chyn.madu@gmail.com
• Study Contact Backup: Name: Cynthia R Sartika, M.Sc; Email: c.sartika@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Recruiting
      • Cipto Mangunkusumo Hospital
      • Contact: Wahyu purnomo, GP; Phone Number: 082190790535; Email: wahyupurnama@gmail.com
      • Contact: Rima Haifa, B.Sc; Phone Number: 085717109438; Email: asct.prostem@gmail.com
      • Principal Investigator: Chyntia O jasirwan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: intravenous injection of UC-MSC; The dosage of the intravenous route is 100 million MSCs for each subject.

Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: PT. Prodia Stem Cell Indonesia
• Investigators: Principal Investigator: Chyntia O Jasirwan, PhD, Cipto Mangunkusumo Hospital, Jakarta

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2018
• Primary Completion (ANTICIPATED): June 20, 2023
• Study Completion (ANTICIPATED): December 20, 2023

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Umbilical Cord Mesenchymal Stem Cell; Allogeneic Mesenchymal Stem Cell; liver cirrhosis due to type B hepatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Fibrosis; Hepatitis B; Hepatitis; Liver Cirrhosis
• Other Study ID Numbers: CT/LC/01/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No