Status:
UNKNOWN
Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B
Lead Sponsor:
PT. Prodia Stem Cell Indonesia
Conditions:
Liver Cirrhoses
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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.
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04357600
Start Date
May 17 2018
End Date
December 20 2023
Last Update
June 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cipto Mangunkusumo hospital
Jakarta, DKI Jakarta, Indonesia