Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

Phase 2

Completed

• Conditions: Stroke; Middle Cerebral Artery Infarction
• Interventions: Procedure: Intercerebral implantation of Autulogous Stem Cells; Drug: convention therapy

• Registration Number: NCT00950521
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-20
• Last Update Posted: 2011-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBSC Treatment	Intercerebral implantation of Autulogous Stem Cells	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	convention therapy	Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication

Primary Outcome Measures

Name	Time	Method
NIH-stroke scale (NIHSS)	1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
European stroke scale (ESS)	1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
European stroke motor subscale (EMS)	1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Barthel index and Mini-Mental State Examination (MMSE)	1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Magnetic resonance imaging (MRI) and computed tomography (CT) scans	1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan