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The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg |
|
| Group 2 | Placebo Comparator | Aspirin Tablet, 100mg/d; Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) | Biological | Allogeneic umbilical cord mesenchymal stem cells will transfusion into by forearm intravenous transplantation, 0.5 - 1 *10^6/kg. once a month, total 3 times. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related-adverse events counting | patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale | After the first time transplantation, follow-up visit for 26 weeks. Based on Modified Rankin Scale, counting the percentage of different symptom changes to evaluate MSC efficacy:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Temuqile | Inner Mongolia International Mongolian Hospital | Study Director |
| Lei Guo, Dr. | China-Japan Union Hospital, Jilin University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inner Mongolia International Mongolian Hospital | Hohhot | Inner Mongolia | 010065 | China |
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| Aspirin Tablet | Drug | Drug: Aspirin Tablet, 100 mg/d |
|
| 26 weeks |
| Barthel activities of daily living (ADL) Index | Based on Activity of Daily Living Scale (ADL) to counting the percentage of patients in following condition:
| 26 weeks |
| NIH stroke scale (NIHSS) | According to NIHSS changes after the treatment, evaluate MSCs efficacy by counting the percentage of patients in following condition:
| 26 weeks |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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