Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke - Full Text View

Sponsor:	China Medical University Hospital
Information provided by (Responsible Party):	Shinn-Zong Lin, China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT01438593

Purpose

The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.

Condition	Intervention	Phase
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
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy

MedlinePlus related topics: Brain Diseases

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:

Change from baseline in NIH Stroke Scale (NIHSS) [ Time Frame: Change from baseline in NIHSS at 1 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Evaluate change from baseline in NIHSS at 12 weeks

Secondary Outcome Measures:

Change from baseline in Brain Image [ Time Frame: Change from baseline in Brain Image at 1 week ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	6
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell

Other Names:

Hematopoietic stem cell
Cord Blood Stem Cell
UCB Stem Cell

Detailed Description:

The study will use CD34+ cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 5 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438593

Contacts

Contact: Woei-Cherng Shyu, M.D.;PhD.

886-4-22052121 ext 7813

Shyu9423@gmail.com

Locations

Taiwan
China Medical University Hospital	Not yet recruiting
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.

Sponsors and Collaborators

China Medical University Hospital

Investigators

Principal Investigator:

Shinn-Zong Lin, M.D.;PhD.

China Medical University Hospital

More Information

No publications provided

Responsible Party:	Shinn-Zong Lin, Professor of Neurosurgery, China Medical University, China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT01438593 History of Changes
Other Study ID Numbers:	DMR97-IRB-178-4
Study First Received:	September 7, 2011
Last Updated:	September 28, 2011
Health Authority:	Taiwan: Department of Health

Keywords provided by China Medical University Hospital:

Stroke
Brain disease
Ischemia
Cerebral infraction
Cord Blood

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Brain Ischemia
Infarction
Ischemia
Infarction, Middle Cerebral Artery
Brain Infarction
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Cerebral Arterial Diseases
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on May 23, 2012