A Phase 1 interventional study of autologous hematopoiesis stem cell transplantation and Aspirin in Stroke, sponsored by Zhejiang Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-01-25.
Sponsored by Zhejiang Hospital · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Zhejiang Hospital is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Procedure: autologous hematopoiesis stem cell transplantation · Drug: Aspirin · Drug: Warfarin · Drug: Atorvastatin · Drug: Edaravone
The control group just receive drug therapy.
Drug: Aspirin · Drug: Warfarin · Drug: Atorvastatin · Drug: Edaravone
Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
aspirin 100mg,qd,po(patients with no fibrillation atrial)
warfarin 2\~6mg,qd,po(patients with fibrillation atrial);
atorvastatin 20mg,qd,po
edaravone 30mg,bid,ivgtt.
aspirin 100mg,qd,po(patients with no fibrillation atrial)
warfarin 2\~6mg,qd,po(patients with fibrillation atrial)
atorvastatin 20mg,qd,po
edaravone 30mg,bid,ivgtt
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months
Time frame: 1,3,6,12 months after cell transplantation
Barthel index
Time frame: 1,3,6,12 months after cell transplantation
perfusion magnetic resonance imaging scan
Time frame: 1,3,6,12 months after cell transplantation
Modified Rankin Scale(mRS)
Time frame: 3,6,12 months after cell transplantation
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Zhejiang Hospital