Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

April 20, 2011 updated by: China Medical University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PBSC Treatment
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
Procedure: Intercerebral implantation of Autulogous Stem Cells
2-8 millions Stem cell per patients plus convention therapy
Other Names:
  • PBSC
  • CD34 Stem Cell
Active Comparator: Control
Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication
Drug: convention therapy
antiplatelet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NIH-stroke scale (NIHSS)
Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Shinn-Zong Lin, MD, DMSci, China Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 30, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

April 21, 2011

Last Update Submitted That Met QC Criteria

April 20, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMR-96-IRB-145
  • DOH Approval No:098004365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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