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NCT Number: NCT00950521

Efficacy Study of CD34 Stem Cell 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.

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Key information

Conditions

Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Infarction, Middle Cerebral Artery Intracranial Arterial Diseases Ischemia Middle Cerebral Artery Infarction Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

China Medical University Hospital

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intercerebral implantation of Autulogous Stem Cells

Procedure

2-8 millions Stem cell per patients plus convention therapy

Other names: PBSC, CD34 Stem Cell

convention therapy

Drug

antiplatelet

Primary outcomes

  1. NIH-stroke scale (NIHSS)

    Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

Secondary outcomes

  1. European stroke scale (ESS)

    Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

  2. European stroke motor subscale (EMS)

    Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

  3. Barthel index and Mini-Mental State Examination (MMSE)

    Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

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

    Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 31, 2009
Registry last updated
Apr 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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