Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke
NCT ID: NCT01438593
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
6 participants
INTERVENTIONAL
2013-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HUCB, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.
Intercerebral implantation of allogenic CD34+ stem cell
Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
Interventions
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Intercerebral implantation of allogenic CD34+ stem cell
Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
3. Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
4. Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 5-15.
5. Subjects must have stroke in the middle cerebral artery territory.
6. Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
7. Subjects must be able to read and understand the informed consent form that has been approved by the appropriate Institutional Review Board (IRB). The subject must sign and date the informed consent form before any study-specific procedures. (Note: If a subject consents to participation but is not in a position to sign and date the informed consent form personally because of his or her physical conditions, the consent form must be confirmed orally at the time of consent, marked or finger printed by the subject voluntarily). The informed consent procedure must be observed by an independent witness who is present throughout the whole informed consent process and sign the consent form.
Exclusion Criteria
2. Pregnant or lactating women.
3. History of alcohol or drug abuse in the previous 3 months.
4. Subjects must not have the following conditions in documents:
* significant renal, cardiovascular, hepatic, or psychiatric disease
* abnormal blood coagulation parameters,
* immunodeficiency (e.g. AIDS)
* tumors, leukemia, and other cancer that may interfere with the clinical trial protocol
* infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation.
5. Subject must not be currently participating in another investigational study or taking any investigational drug within the last four weeks before the screening of this study.
6. Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study.
35 Years
70 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Shinn-Zong Lin
Professor of Neurosurgery, China Medical University
Principal Investigators
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Shinn-Zong Lin, M.D.;PhD.
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
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China Medical University Hospital
Taichung, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Woei-Cherng Shyu, M.D.;PhD.
Role: primary
Other Identifiers
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DMR97-IRB-178-4
Identifier Type: -
Identifier Source: org_study_id