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This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.
40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Allogeneic umbilical cord mesenchymal stem cells |
|
| Control group | Placebo Comparator | Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo:saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cell | Biological | Experimental group receive Allogeneic umbilical cord mesenchymal stem cell,i.v (SCLnow 19#) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor function analysis | Based on Activity of Daily Living Scale (ADL) to analysis efficacy of cell treatment.The score of patient with upper limb >60, and total score >90 is considered good recovery. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological deficits analysis | According to Chinese scale of clinical neurologic deficit to analysis, the result as follow:
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wulan | 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 Enteric-coated Tablets & Atorvastatin Calcium | Drug | Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth. |
|
| Limb motor function analysis | Using fugl-meyer assessment evaluate motor function. Mild movement disorder: 96 - 99; Moderate movement disorder: 85 - 95; Obvious movement disorder: 50 - 84; Serious movement disorder: < 50 | 6 months |
| Barthel Index analysis | Obvious effective: Barthel Index score between 96 - 99, patient with self care ability. Effective:Barthel Index score between 70 - 89, patient with condition improved. Invalid: The effect do not meet above standards. | 6 months |
| 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 |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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