Stroke
Conditions
Keywords
stroke, hematopoietic stem cell transplantation
Brief summary
The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.
Detailed description
Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.
Interventions
PROCEDUREautologous hematopoiesis stem cell transplantation
Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
DRUGAspirin
aspirin 100mg,qd,po(patients with no fibrillation atrial)
DRUGWarfarin
warfarin 2\ 6mg,qd,po(patients with fibrillation atrial);
DRUGAtorvastatin
atorvastatin 20mg,qd,po
DRUGEdaravone
edaravone 30mg,bid,ivgtt.
Sponsors
Zhejiang University
Zhejiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* aged 40\ 70 * no consciousness disorders * internal carotid artery territory infarction * stroke happened \< 1 year * with stable hemiplegia, but remain dependent in daily life * SSS(Scandinavian Stroke Scale) \< 40
Exclusion criteria
* pregnant women * can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in NIH-stroke scale (NIHSS) at 12 months | 1,3,6,12 months after cell transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Barthel index | 1,3,6,12 months after cell transplantation |
| perfusion magnetic resonance imaging scan | 1,3,6,12 months after cell transplantation |
| Modified Rankin Scale(mRS) | 3,6,12 months after cell transplantation |
Countries
China
Contacts
Primary ContactYaguo Li, master
Backup ContactYumiao Zhou, master
Outcome results
None listed