Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950521
• Other study ID #: DMR-96-IRB-145
• Secondary ID: DOH Approval No:
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2009
• Last updated: April 20, 2011
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2011
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Infarction, Middle Cerebral Artery
• Middle Cerebral Artery Infarction
• Stroke

Intervention

Procedure:
• Intercerebral implantation of Autulogous Stem Cells
2-8 millions Stem cell per patients plus convention therapy

Drug:
• convention therapy
antiplatelet

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIH-stroke scale (NIHSS)		1, 2, 4, 12 weeks, and confirmed at 6 and 12 months	Yes
Secondary	European stroke scale (ESS)		1, 2, 4, 12 weeks, and confirmed at 6 and 12 months	Yes
Secondary	European stroke motor subscale (EMS)		1, 2, 4, 12 weeks, and confirmed at 6 and 12 months	Yes
Secondary	Barthel index and Mini-Mental State Examination (MMSE)		1, 2, 4, 12 weeks, and confirmed at 6 and 12 months	Yes
Secondary	Magnetic resonance imaging (MRI) and computed tomography (CT) scans		1, 2, 4, 12 weeks, and confirmed at 6 and 12 months	Yes