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| Name | Class |
|---|---|
| Tarumanagara University | OTHER |
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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 epilepsy. The main questions it ams to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secretome Injection | Experimental | patient will receive 4 times secretome injection every two weeks for two months |
|
| Best Treatment Practice | No Intervention | patient will receive standart therapy for four months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secretome | Drug | 3 ml Injection of secretome for 4 times two weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections | Patients achieved a response if there are changes in frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections.Best outcome when the frequency and duration of the seizures less frequent, worst outcome when the frequency and duration of the seizures get more frequent | From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months |
| Changes in EEG and qEEG (Alpha,Beta, Delta, and Theta wave) results of drugs resistant epilepsy after two months secretome injections | Patients achieved a response if there are changes in EEG and qEEG (Alpha,Beta, Delta, and Theta wave) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the EEG and qEEG (Alpha,Beta, Delta, and Theta wave) get a better results, worst outcome when EEG and qEEG (Alpha,Beta, Delta, and Theta wave) get a worse results | From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Mini Mental State Examination (MMSE) results of drugs resistant epilepsy after two months secretome injections | Patients achieved a response if there are changes in Mini Mental State Examination (MMSE) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the Mini Mental State Examination (MMSE) get a increase results, worst outcome when Mini Mental State Examination (MMSE) get a decrease results |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of The Life in Epilepsy Inventory (QOLIE-31) results of drugs resistant epilepsy after two months secretome injections | Patients achieved a response if there are changes in Quality of The Life in Epilepsy Inventory (QOLIE-31) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the Quality of The Life in Epilepsy Inventory (QOLIE-31) get a increase results, worst outcome when Quality of The Life in Epilepsy Inventory (QOLIE-31) get a decrease results |
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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Clinic Prof. Dadang Hawari | Jakarta | DKI Jakarta | 12810 | Indonesia |
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|---|---|
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Case Report Form (all collected IPD)
After publication with no end date
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| From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months |
| Changes in Perceived Stress Scale (PSS) results of drugs resistant epilepsy after two months secretome injections | Patients achieved a response if there are changes in Perceived Stress Scale (PSS) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the Perceived Stress Scale (PSS) get a increase results, worst outcome when Perceived Stress Scale (PSS) get a decrease results | From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months |
| Changes in Gait Deviation Index (GDI) results of drugs resistant epilepsy after two months secretome injections | Patients achieved a response if there are changes in Gait Deviation Index (GDI) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the Gait Deviation Index (GDI) get a increase results, worst outcome when Gait Deviation Index (GDI) get a decrease results | From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months |
| From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000089282 | Secretome |
| ID | Term |
|---|---|
| D055442 | Metabolome |
| D008660 | Metabolism |
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