Clinical trial NCT01438593: Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ischemic Stroke
Ischaemic Cerebral Infarction
Infarction, Middle Cerebral Artery
Ischemia
Brain Ischemia
Keywords: Stroke
Brain disease
Ischemia
Cerebral infraction
Cord Blood
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 6
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: Inclusion Criteria:

1. Subjects can be of either gender and must be between 35 through 75 years of age.
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:

1. 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.
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.

Primary outcomes:
measure: Change from baseline in NIH Stroke Scale (NIHSS)
timeFrame: Change from baseline in NIHSS at 1 weeks
measure: Change from Baseline in NIH Stroke Scale(NIHSS)
timeFrame: Change from Baseline in NIHSS at 2 weeks
measure: Change from baseline in NIH Stroke Scale
timeFrame: Change from baseline in NIHSS at 4 weeks
measure: Change from baseline in NIH Stroke Scale ( NIHSS)
timeFrame: Change from baseline in NIHSS at 12 weeks
Secondary outcomes:
measure: Change from baseline in Brain Image
timeFrame: Change from baseline in Brain Image at 1 week
measure: Change from baseline in Brain Image
timeFrame: Change from baseline in Brain Image at 4 weeks
measure: Change from baseline in Brain Image
timeFrame: Change from baseline in Brain Image at 6 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Shinn-Zong Lin, M.D.;PhD.
role: PRINCIPAL_INVESTIGATOR
References: