Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

NCT ID: NCT01518231

Last Updated: 2012-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cell transplantation

The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.

Group Type EXPERIMENTAL

autologous hematopoiesis stem cell transplantation

Intervention Type PROCEDURE

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

Aspirin

Intervention Type DRUG

aspirin 100mg,qd,po(patients with no fibrillation atrial)

Warfarin

Intervention Type DRUG

warfarin 2\~6mg,qd,po(patients with fibrillation atrial);

Atorvastatin

Intervention Type DRUG

atorvastatin 20mg,qd,po

Edaravone

Intervention Type DRUG

edaravone 30mg,bid,ivgtt.

Convention therapy

The control group just receive drug therapy.

Group Type NO_INTERVENTION

Aspirin

Intervention Type DRUG

aspirin 100mg,qd,po(patients with no fibrillation atrial)

Warfarin

Intervention Type DRUG

warfarin 2\~6mg,qd,po(patients with fibrillation atrial)

Atorvastatin

Intervention Type DRUG

atorvastatin 20mg,qd,po

Edaravone

Intervention Type DRUG

edaravone 30mg,bid,ivgtt

Interventions

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autologous hematopoiesis stem cell transplantation

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

Intervention Type PROCEDURE

Aspirin

aspirin 100mg,qd,po(patients with no fibrillation atrial)

Intervention Type DRUG

Warfarin

warfarin 2\~6mg,qd,po(patients with fibrillation atrial);

Intervention Type DRUG

Atorvastatin

atorvastatin 20mg,qd,po

Intervention Type DRUG

Edaravone

edaravone 30mg,bid,ivgtt.

Intervention Type DRUG

Aspirin

aspirin 100mg,qd,po(patients with no fibrillation atrial)

Intervention Type DRUG

Warfarin

warfarin 2\~6mg,qd,po(patients with fibrillation atrial)

Intervention Type DRUG

Atorvastatin

atorvastatin 20mg,qd,po

Intervention Type DRUG

Edaravone

edaravone 30mg,bid,ivgtt

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role collaborator

Zhejiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yaguo Li

Yaguo Li

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaguo Li, master

Role: STUDY_DIRECTOR

Zhejiang Hospital

Yumiao Zhou, master

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Hospital

Locations

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Yaguo Li

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yaguo Li, master

Role: CONTACT

0086-0571-87987373 ext. 5103

Yumiao Zhou, master

Role: CONTACT

0086-0571-87987373 ext. 5094

Facility Contacts

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Yumiao Zhou, master

Role: primary

0086-0571-87987373 ext. 5094

Other Identifiers

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Zhejiang Hospital

Identifier Type: -

Identifier Source: org_study_id

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