Liver Cirrhoses
Conditions
Keywords
Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, liver cirrhosis due to type B hepatitis
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 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
Interventions
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.
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study model is considered as a single group assignment since all the participants are being administered with the same treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Pugh Score | 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. |
| Examination of liver function | 1 month after injection | assessed from SGOT and SGPT values in laboratory tests result |
| MELD Score | 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. |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORChyntia O Jasirwan, PhD
Cipto Mangunkusumo Hospital, Jakarta
STUDY_CHAIRRima Haifa, B.Sc
Prodia Stem Cell Indonesia
Outcome results
None listed