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| Name | Class |
|---|---|
| Tarumanagara University | OTHER |
| Liver Clinic Prof Ali Sulaiman | UNKNOWN |
| Pelni Hospital | UNKNOWN |
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The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with liver cirrhosis. The main questions it ams to answer are:
Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored and given their usual drugs)
Patients will:
Be injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months. Do several test such us fibroscan, stroop test, psychometric hepatic encephalopathy score, short form 36 questionnaire, IL-6, TNF alfa and blood test for albumin, SGOT, SGPT, direct bilirubin, indirect bilirubin, INR, creatinine, ureum, hemoglobin, hematocrite, leukocyte, and thrombocyte.
Visit the clinic once every two weeks to receive drugs and treatment for 4 months.
Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment),10th months (6 months post treatment)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secretome Injection | Experimental | patient will receive secretome injection every two weeks for four months |
|
| Best Treatment Practice | No Intervention | patient will receive hepatoprotector drugs and Urodeoxycolate acid for four months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secretome | Drug | 3 ml Injection of secretome for 8 times two weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fibroscan and M2BPGi six month after secretome injections | Patients achieved a response if there are changes in Fibroscan and M2BPGi after secretome injections within six months.best outcome when the M2BPGi Fibroscan decrease, worst outcome when the M2BPGi and Fibroscan increase | From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months |
| Changes in Complete Blood Count and Kidney function after secretome injections | Secretome is safe If hemoglobin and hematocrit, leukocyte, platelet, ureum, and creatinine are still in normal level after secretome injection (best outcome) Secretome is not safe if hemoglobin and hematocrit, leukocyte, platelet, ureum, and creatinine are out of the normal level after secretome injection (worst outcome) | From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months |
| Changes of albumin, SGOT and SGPT levels in six month after secretome injections | Patients achieved a response if there are changes in albumin, SGOT and SGPT levels after secretome injections within six months.best outcome when the albumin, SGOT and SGPT decrease, worst outcome when the albumin, SGOT and SGPT increase | From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of CTP and MELD score in six month after secretome injections | Patients achieved a response if there are changes in CTP and MELD score after secretome injections within six months.best outcome when the CTP and MELD score decrease, worst outcome when the CTP and MELD score increase | From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hans Ulrich Baer, Prof. Dr. med | Contact | 628156963254 | hans.baer@baermed.ch | |
| Siufui Hendrawan, M.D., Ph.D. | Contact | +41 387 30 70 | siufui@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver Clinic Prof Ali Sulaiman | Jakarta | DKI Jakarta | 10150 | Indonesia |
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| Label | URL |
|---|---|
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Case Report Form (all collected IPD)
After publication with no end date
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| Changes of IL-6 and TNF-α levels in six month after secretome injections | Patients achieved a response if there are changes in IL-6 and TNF-α levels after secretome injections within six months.best outcome when the IL-6 and TNF-α decrease, worst outcome when the IL-6 and TNF-α increase | From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months |
| Changes of Stroop test dan PHES score in six month after secretome injections | Patients achieved a response if there are changes inStroop test dan PHES score after secretome injections within six months.best outcome when the Stroop test dan PHES score increase, worst outcome when the Stroop test dan PHES score decrease | From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months |
| Changes of SF-36 questionnaire score in six month after secretome injections | Patients achieved a response if there are changes in SF-36 questionnaire score after secretome injections within six months.best outcome when the SF-36 questionnaire score increase, worst outcome when the SF-36 questionnaire score decrease | From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000089282 | Secretome |
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D055442 | Metabolome |
| D008660 | Metabolism |
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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