Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

Stroke Clinical Trial

— AHSCTIS  

Official title:

Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01518231
• Other study ID #: Zhejiang Hospital
• Status: Recruiting
• Phase: Phase 1
• First received: January 10, 2012
• Last updated: January 24, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2012
• Source: Zhejiang Hospital
• Contact: Yaguo Li, master
• Phone: 0086-0571-87987373
• Email: tjqlyg[@]163.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Department of Zhejiang Province
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• autologous hematopoiesis stem cell transplantation
Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.

Drug:
• Aspirin
aspirin 100mg,qd,po(patients with no fibrillation atrial)
• Warfarin
warfarin 2~6mg,qd,po(patients with fibrillation atrial);
• Atorvastatin
atorvastatin 20mg,qd,po
• Edaravone
edaravone 30mg,bid,ivgtt.
• Aspirin
aspirin 100mg,qd,po(patients with no fibrillation atrial)
• Warfarin
warfarin 2~6mg,qd,po(patients with fibrillation atrial)
• Atorvastatin
atorvastatin 20mg,qd,po
• Edaravone
edaravone 30mg,bid,ivgtt

Locations

Country	Name	City	State
China	Yaguo Li	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Hospital	Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in NIH-stroke scale (NIHSS) at 12 months		1,3,6,12 months after cell transplantation	Yes
Secondary	Barthel index		1,3,6,12 months after cell transplantation	Yes
Secondary	perfusion magnetic resonance imaging scan		1,3,6,12 months after cell transplantation	Yes
Secondary	Modified Rankin Scale(mRS)		3,6,12 months after cell transplantation	Yes