Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)

This study is currently recruiting participants.

Verified January 2012 by Zhejiang Hospital

Sponsor:

Collaborator:

Zhejiang University

Information provided by (Responsible Party):

Yaguo Li, Zhejiang Hospital

ClinicalTrials.gov Identifier:

NCT01518231

First received: January 10, 2012

Last updated: January 24, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 10, 2012

Last Updated Date

January 24, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from Baseline in NIH-stroke scale (NIHSS) at 12 months [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01518231 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Barthel index [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
perfusion magnetic resonance imaging scan [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
Modified Rankin Scale(mRS) [ Time Frame: 3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Stroke

Intervention ^ICMJE

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)
Drug: Warfarin
warfarin 2~6mg,qd,po(patients with fibrillation atrial);
Drug: Atorvastatin
atorvastatin 20mg,qd,po
Drug: Edaravone
edaravone 30mg,bid,ivgtt.
Drug: Warfarin
warfarin 2~6mg,qd,po(patients with fibrillation atrial)
Drug: Edaravone
edaravone 30mg,bid,ivgtt

Study Arm (s)

Experimental: cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Interventions:
- Procedure: autologous hematopoiesis stem cell transplantation
- Drug: Aspirin
- Drug: Warfarin
- Drug: Atorvastatin
- Drug: Edaravone
No Intervention: Convention therapy
The control group just receive drug therapy.
Interventions:
- Drug: Aspirin
- Drug: Warfarin
- Drug: Atorvastatin
- Drug: Edaravone

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yaguo Li, master	0086-0571-87987373 ext 5103	tjqlyg@163.com
Contact: Yumiao Zhou, master	0086-0571-87987373 ext 5094	zlf859@yahoo.com.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01518231

Other Study ID Numbers ^ICMJE

Zhejiang Hospital

Has Data Monitoring Committee

Responsible Party

Yaguo Li, Zhejiang Hospital

Study Sponsor ^ICMJE

Zhejiang Hospital

Collaborators ^ICMJE

Zhejiang University

Investigators ^ICMJE

Study Director:	Yaguo Li, master	Zhejiang Hospital
Principal Investigator:	Yumiao Zhou, master	Zhejiang Hospital

Information Provided By

Zhejiang Hospital

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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