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The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous injection of UC-MSC | Experimental | The dosage of the intravenous route is 100 million MSCs for each subject. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chyntia O Jasirwan, PhD | Cipto Mangunkusumo Hospital, Jakarta | Principal Investigator |
| Rima Haifa, B.Sc | Prodia Stem Cell Indonesia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo hospital | Jakarta | DKI Jakarta | Indonesia |
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The study model is considered as a single group assignment since all the participants are being administered with the same treatment.
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| 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 |