Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke

An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells

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.

Study Overview

• Status: Unknown
• Conditions: Ischemia; Ischemic Stroke; Brain Ischemia; Infarction, Middle Cerebral Artery; Ischaemic Cerebral Infarction
• Intervention / Treatment: Procedure: Intercerebral implantation of allogenic CD34+ 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

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Woei-Cherng Shyu, M.D.;PhD.; Phone Number: 7813 886-4-22052121; Email: shyu9423@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 244
    • China Medical University Hospital
    • Contact: Woei-Cherng Shyu, M.D.;PhD.; Phone Number: 7813 886-4-22052121; Email: shyu9423@gmail.com
    • Principal Investigator: Shinn-Zong Lin, M.D.;PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HUCB, Medicine, Rehabilitation; Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.	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: Hematopoietic stem cell; Cord Blood Stem Cell; UCB Stem Cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in NIH Stroke Scale (NIHSS)	Evaluate change from Baseline in NIHSS at 1 week	Change from baseline in NIHSS at 1 weeks
Change from Baseline in NIH Stroke Scale(NIHSS)	Evaluate change from Baseline in NIHSS at 2 weeks	Change from Baseline in NIHSS at 2 weeks
Change from baseline in NIH Stroke Scale	Evaluate change from baseline in NIHSS at 4 weeks	Change from baseline in NIHSS at 4 weeks
Change from baseline in NIH Stroke Scale ( NIHSS)	Evaluate change from baseline in NIHSS at 12 weeks	Change from baseline in NIHSS at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Brain Image	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 at 1 week
Change from baseline in Brain Image	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 at 4 weeks
Change from baseline in Brain Image	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.	Change from baseline in Brain Image at 6 months

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Shinn-Zong Lin, M.D.;PhD., China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 21, 2011
• First Posted (Estimate): September 22, 2011

Study Record Updates

• Last Update Posted (Estimate): August 2, 2012
• Last Update Submitted That Met QC Criteria: July 31, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Stroke; Ischemia; Brain disease; Cord Blood; Cerebral infraction
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Infarction; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Stroke; Ischemic Stroke; Brain Ischemia; Ischemia; Cerebral Infarction; Infarction, Middle Cerebral Artery
• Other Study ID Numbers: DMR97-IRB-178-4