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The purpose of this study was to determine the effectiveness of a combination of intranasal conditioned medium (CM) with intraparenchymal umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in acute stroke patients to induce neurogenesis.
This study has 3 arms namely CM and UC-MSCs treatment, UC-MSCs treatment only, and control. The investigator hypothesized that group of CM and UC-MSCs combination is the optimal treatment to induce neurogenesis in stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment | Experimental | Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10^6 UC-MSCs |
|
| Umbilical cord mesenchymal stem cells treatment | Experimental | Intra-parenchymal transplantation of 20x10^6 UC-MSCs |
|
| Standard treatment (control) | Active Comparator | Neurologic and Neutrophic Drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conditioned Medium | Biological | Intranasal of 3 cc of conditioned medium each, for 3 days in a row |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation | Venous blood collection | Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment |
| Change from baseline Vascular endothelial growth factor at one month, 3 months and 6 months after transplantation | Venous blood collection | Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment |
| Change baseline Magnetic Resonance Imaging at 6 month after transplantation | To observe the brain development (neurogenesis) | Before treatment, 6 month after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| The National Institute of Health Stroke Scale (NIHSS) Scoring | The NIH Stroke Scale (NIHSS) is a 15-item scale that is a well-validated and prognostically important measure of stroke-related neurologic deficits in research and clinical care | Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rima Haifa | Prodia StemCell Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gatot Soebroto Hospital | Jakarta Pusat | DKI Jakarta | 10410 | Indonesia | ||
| PT Prodia StemCell Indonesia |
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|
| Umbilical Cord Mesenchymal Stem Cells | Biological | Intra-parenchymal transplantation of 20x10^6 UC-MSCs |
|
|
| Neurologic and Neutrophic Drugs | Procedure | Such as clopidogrel, piracetam, citicoline |
|
| modified Rankin Scale (mRS) |
The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke |
| Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment |
| Jakarta |
| Indonesia |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017077 | Culture Media, Conditioned |
| D000089282 | Secretome |
| ID | Term |
|---|---|
| D003470 | Culture Media |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D004864 | Equipment and Supplies |
| D055442 | Metabolome |
| D008660 | Metabolism |
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