Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

Phase 1

• Conditions: Stroke
• Interventions: Procedure: autologous hematopoiesis stem cell transplantation; Drug: Aspirin; Drug: Warfarin; Drug: Atorvastatin; Drug: Edaravone

• Registration Number: NCT01518231
• Lead Sponsor: Zhejiang Hospital

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.

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-24
• Last Update Submitted: 2012-01-24
• Study First Posted: 2012-01-25
• Last Update Posted: 2012-01-25
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cell transplantation	autologous hematopoiesis stem cell transplantation	The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
cell transplantation	Warfarin	The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Convention therapy	Aspirin	The control group just receive drug therapy.
cell transplantation	Aspirin	The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
cell transplantation	Atorvastatin	The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
cell transplantation	Edaravone	The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Convention therapy	Warfarin	The control group just receive drug therapy.
Convention therapy	Atorvastatin	The control group just receive drug therapy.
Convention therapy	Edaravone	The control group just receive drug therapy.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months	1,3,6,12 months after cell transplantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yaguo Li; 🇨🇳 Hangzhou, Zhejiang, China