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

Liver Cirrhoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04357600
• Other study ID #: CT/LC/01/2018
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 17, 2018
• Est. completion date: December 20, 2023

Study information

• Verified date: June 2022
• Source: PT. Prodia Stem Cell Indonesia
• Contact: Chyntia O Jasirwan, PhD
• Phone: 08121058683
• Email: chyn.madu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis B
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Examination of liver function	assessed from SGOT and SGPT values in laboratory tests result	1 month after injection
Primary	Examination of liver function	assessed from SGOT and SGPT values in laboratory tests result	3 months after injection
Primary	Examination of liver function	assessed from SGOT and SGPT values in laboratory tests result	6 months after injection
Primary	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
Primary	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
Primary	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