Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke
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ClinicalTrials.gov Identifier: NCT01438593 |
Recruitment Status : Unknown
Verified December 2011 by Shinn-Zong Lin, China Medical University Hospital.
Recruitment status was: Not yet recruiting
First Posted : September 22, 2011
Last Update Posted : August 2, 2012
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Condition or disease | Intervention/treatment | Phase |
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Ischemic Stroke Ischaemic Cerebral Infarction Infarction, Middle Cerebral Artery Ischemia Brain Ischemia | Procedure: Intercerebral implantation of allogenic CD34+ stem cell | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells |
Study Start Date : | January 2013 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
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Experimental: HUCB, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.
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Procedure: 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 Names:
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- Change from baseline in NIH Stroke Scale (NIHSS) [ Time Frame: Change from baseline in NIHSS at 1 weeks ]Evaluate change from Baseline in NIHSS at 1 week
- Change from Baseline in NIH Stroke Scale(NIHSS) [ Time Frame: Change from Baseline in NIHSS at 2 weeks ]Evaluate change from Baseline in NIHSS at 2 weeks
- Change from baseline in NIH Stroke Scale [ Time Frame: Change from baseline in NIHSS at 4 weeks ]Evaluate change from baseline in NIHSS at 4 weeks
- Change from baseline in NIH Stroke Scale ( NIHSS) [ Time Frame: Change from baseline in NIHSS at 12 weeks ]Evaluate change from baseline in NIHSS at 12 weeks
- Change from baseline in Brain Image [ Time Frame: Change from baseline in Brain Image at 1 week ]Brain Image will be performed by MRI. The MRI evaluation includes DEI, T1W, T2W, MRS, and DTI, and change from baseline will be evaluated at 1 week
- Change from baseline in Brain Image [ Time Frame: Change from baseline in Brain Image at 4 weeks ]Brain Image will be performed by MRI. The MRI evaluation includes DEI,T1W,T2W,MRS and DTI , and evaluate the change from baseline at 4 weeks
- Change from baseline in Brain Image [ Time Frame: Change from baseline in Brain Image at 6 months ]Brain Image will be performed by MRI.MRI image includes DEI,T1W, T2W, and DTI, and change from baseline will be evaluated at 6 months.

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Ages Eligible for Study: | 35 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects can be of either gender and must be between 35 through 75 years of age.
- Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
- Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
- 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.
- Subjects must have stroke in the middle cerebral artery territory.
- Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
- 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:
- Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory.
- Pregnant or lactating women.
- History of alcohol or drug abuse in the previous 3 months.
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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.
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438593
Contact: Woei-Cherng Shyu, M.D.;PhD. | 886-4-22052121 ext 7813 | Shyu9423@gmail.com |
Taiwan | |
China Medical University Hospital | |
Taichung, Taiwan, 244 | |
Contact: Woei-Cherng Shyu, M.D.;PhD. 886-4-22052121 ext 7813 shyu9423@gmail.com | |
Principal Investigator: Shinn-Zong Lin, M.D.;PhD. |
Principal Investigator: | Shinn-Zong Lin, M.D.;PhD. | China Medical University Hospital |
Responsible Party: | Shinn-Zong Lin, Professor of Neurosurgery, China Medical University, China Medical University Hospital |
ClinicalTrials.gov Identifier: | NCT01438593 |
Other Study ID Numbers: |
DMR97-IRB-178-4 |
First Posted: | September 22, 2011 Key Record Dates |
Last Update Posted: | August 2, 2012 |
Last Verified: | December 2011 |
Stroke Brain disease Ischemia Cerebral infraction Cord Blood |
Stroke Ischemic Stroke Cerebral Infarction Brain Ischemia Infarction, Middle Cerebral Artery Ischemia Infarction Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Necrosis Brain Infarction Cerebral Arterial Diseases Intracranial Arterial Diseases |