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This study is to evaluated the safety and efficacy of BMSCs transplantation in the treatment of ischemic stroke, so as to provide a basis for future clinical application of BMSCs transplantation in the treatment of ischemic stroke.
Routine treatment:
1.1. If arterial plaque is found, use lipid-lowering therapy (routine dose of atorvastatin or rosuvastatin). If no plaque is found, use atorvastatin or rosuvastatin based on the maintenance of normal blood lipid;
1.2. If venous thrombosis or arterial plaques are found in the lower limbs, use dabigatran to prevent platelet aggregation; if no vascular problems are found in the lower limbs, use aspirin or clopidogrel to prevent platelet aggregation;
1.3. During the treatment, cerebrovascular stenosis (non responsible vessels) can be treated intravascularly;
1.4. The use of neurotrophic drugs is prohibited during the study;
1.5. Elevated homocysteine was treated with mecobalamin and folic acid;
1.6. Hypertension, diabetes and other basic diseases receive routine treatment, and the combined medication is recorded in the case report form.
Grouping:
2.1. BMSCs group: BMSCs were transplanted on the basis of routine treatment: the transplanted cells were injected intravenously and transplanted in two times, with a dose of 1 × 106 / kg body weight, each volume of 80ml ± 5ml, and the time interval between two transplants was 1 week;
2.2. Routine treatment group: only receiving routine treatment;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine treatment group | No Intervention | No special measures were taken and routine treatment was adopted | |
| BMSCs group | Experimental | BMSCs were transplanted on the basis of routine treatment: the transplanted cells were injected intravenously and transplanted in two times at a dose of 1 × 106/kg body weight, each volume was 80ml ± 5ml, and the time interval between two transplants was 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation of self BMSCs | Biological | Bone marrow was collected, cultured in vitro and injected back into the body |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline after the first transplant. | The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline at week 96 ±30 days after the first transplant. | 96 weeks ±30 days after the first transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score after the first transplantation | The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Xiaodan | Contact | 18680288751 | jiangxd@smu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510220 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Improvement rate of the modified Barthel Index Rating Scale score from baseline after the first transplant |
Improvement rate of the modified Barthel Index Rating Scale score from baseline at 48 weeks ±15 days after the first transplantation |
| 48 weeks ±15 days after the first transplantation |
| Improvement rate of the modified Barthel Index Rating Scale score from baseline | Improvement rate of the modified Barthel Index Rating Scale score from baseline at 96 weeks ±30 days after the first transplant | 96 weeks ±30 days after the first transplantation |
| Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation | Improvement rate of Fugl-Meyer scale score from baseline at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation | Improvement rate of Fugl-Meyer scale score from baseline at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| Improvement rate of Simple Mental State Examination Scale (MMSE) score | Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| Improvement rate of Simple Mental State Examination Scale (MMSE) score | Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline after the first transplantation | The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline after the first transplantation | The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential after the first transplantation | MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential after the first transplantation | MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline after the first transplantation | The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline after the first transplantation | The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) after the first transplantation | Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) after the first transplantation | Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| Changes in CTA from baseline after the first transplantation | Changes in CTA from baseline at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| Changes in CTA from baseline after the first transplantation | Changes in CTA from baseline at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| Changes in CTP from baseline after the first transplantation | Changes in CTP from baseline at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| Changes in CTP from baseline after the first transplantation | Changes in CTP from baseline at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| Changes in mRS Scores from baseline after the first transplantation | Changes in mRS Scores from baseline at 48 weeks ±15 days after the first transplantation | 48 weeks ±15 days after the first transplantation |
| Changes in mRS Scores from baseline after the first transplantation | Changes in mRS Scores from baseline at 96 weeks ±30 days after the first transplantation | 96 weeks ±30 days after the first transplantation |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |