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Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

Primary Purpose

Stroke, Middle Cerebral Artery Infarction

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Intercerebral implantation of Autulogous Stem Cells

convention therapy

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Stem Cell, Cell Therapy, CD34 Stem cell, Peripheral blood Stem cell

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

aged 35-70 chronic stroke adult patient,
with stroke history of more than 6 months, less than 60 months，
with stable hemiplegia condition, and
NIHSS (NIH Stroke Scale) score is between 9-20.

Exclusion Criteria:

patients aged less than 35 or more than 70,
hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
pregnant women,
impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.

Sites / Locations

China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PBSC Treatment

Control

Arm Description

Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication

Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication

Outcomes

Primary Outcome Measures

NIH-stroke scale (NIHSS)

Secondary Outcome Measures

European stroke scale (ESS)

European stroke motor subscale (EMS)

Barthel index and Mini-Mental State Examination (MMSE)

Magnetic resonance imaging (MRI) and computed tomography (CT) scans

Full Information

NCT ID

NCT00950521

First Posted

July 30, 2009

Last Updated

April 20, 2011

Sponsor

China Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00950521

Brief Title

Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

Official Title

Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

China Medical University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.

Detailed Description

30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Middle Cerebral Artery Infarction

Keywords

Stroke, Stem Cell, Cell Therapy, CD34 Stem cell, Peripheral blood Stem cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PBSC Treatment

Arm Type

Active Comparator

Arm Description

Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication

Intervention Type

Procedure

Intervention Name(s)

Intercerebral implantation of Autulogous Stem Cells

Other Intervention Name(s)

PBSC, CD34 Stem Cell

Intervention Description

2-8 millions Stem cell per patients plus convention therapy

Intervention Type

Drug

Intervention Name(s)

convention therapy

Intervention Description

antiplatelet

Primary Outcome Measure Information:

Title

NIH-stroke scale (NIHSS)

Time Frame