Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke
Overview
- Phase
- Phase 1
- Intervention
- autologous hematopoiesis stem cell transplantation
- Conditions
- Stroke
- Sponsor
- Zhejiang Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from Baseline in NIH-stroke scale (NIHSS) at 12 months
- Last Updated
- 14 years ago
Overview
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.
Investigators
Yaguo Li
Yaguo Li
Zhejiang Hospital
Eligibility Criteria
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
Arms & Interventions
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Intervention: autologous hematopoiesis stem cell transplantation
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Intervention: Aspirin
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Intervention: Warfarin
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Intervention: Atorvastatin
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Intervention: Edaravone
Convention therapy
The control group just receive drug therapy.
Intervention: Aspirin
Convention therapy
The control group just receive drug therapy.
Intervention: Warfarin
Convention therapy
The control group just receive drug therapy.
Intervention: Atorvastatin
Convention therapy
The control group just receive drug therapy.
Intervention: Edaravone
Outcomes
Primary Outcomes
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months
Time Frame: 1,3,6,12 months after cell transplantation
Secondary Outcomes
- 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)