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Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02433509
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : August 1, 2019
Sponsor:
Collaborators:
StemCyte, Inc.
University of South Florida
Saneron CCEL Therapeutics, Inc.
Buddhist Tzu Chi General Hospital
Information provided by (Responsible Party):
Shinn-Zong Lin, Buddhist Tzu Chi General Hospital

Study Description
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Brief Summary:
The objective of the study is to determine the safely of Human Umbilical Cord Blood mononuclear cells by Intravenous injection in acute ischemic stroke patients.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Other: HUCB monocyte cells Phase 1

Detailed Description:
The study will use Umbilical Cord Blood 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 4 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. Then cells injection by Intravenous in acute ischemic stroke patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: acute ischemic stroke
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke
Study Start Date : May 2015
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: HUCB monocyte cells w/ Mannitol in acute ischemic stroke
  1. The cord blood need to be infusion within less than 10 days after the onset of stroke, with the cord blood mononuclear cells 200 million ~ 500 million will used.
  2. 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .
 Other: HUCB monocyte cells
  1. The cord blood need to be infusion within less than 10 days after the onset of stroke, and the cord blood mononuclear cells 200 million ~ 500 million will used.
  2. 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .
Other Name: 20% Mannnitol


Outcome Measures
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Primary Outcome Measures :
  1. adverse events (AE)and serious adverse reaction(SAE) [ Time Frame: after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months. ]
    any AE or SAE (related or non-related) during the 12-month follow-up period


Secondary Outcome Measures :
  1. Brain Image(MRI) [ Time Frame: baseline, after infusion 24 hours, 1, 6, 12months ]
    changes of Brain Images

  2. abdominal sonography-spleen [ Time Frame: baseline, after infusion 24, 72 hours, 3, 12months ]
    size changes of spleen

  3. NIHSS [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months ]
    neurology functions change

  4. Berg Balance score [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months ]
    motor function changes

  5. Barthel Index [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months ]
    neurology function changes

  6. Blood examination [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months ]
    physical condition monitoring

  7. cytokine family [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months ]
    for study


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The age of Subjects between 45 through 80 years.
  2. Acute Ischemic Stroke.
  3. National Institutes of Health Stroke Scale (NIHSS):6-18
  4. Brain MRI shows the middle cerebral artery region (M1 and M2) of cerebral i infarction stroke patients.
  5. Subjects have no midline shift or hemorrhagic transformation

Exclusion Criteria:

  1. NIHSS score reduced more than 4 within after 24 hours.
  2. Female are pregnant or lactating.
  3. Subjects with impaired liver function, AIDS, cancer or other significant medical condition (including certifiable diseases, rare disease)
  4. Subjects joined other clinical trails or received rt-PA therapy.
  5. Immune dysfunction or receiving other immunosuppressive agents.
  6. Subjects cannot have MRI test
  7. Subjects' HLA typing results match less than 4 out of the 6 genotypes
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02433509


Contacts
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Contact: Shinn-Zong Lin, M.D.;PhD. 886-5-7837901 ext 1204 shinnzong@yahoo.com.tw

Locations
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Taiwan
China Medical University Beigang Hospital Recruiting
Beigang, Yunlin, Taiwan
Contact: shinn-zong Lin, M.D.;PhD.    886-5-7837901 ext 1204      
Sponsors and Collaborators
China Medical University Hospital
StemCyte, Inc.
University of South Florida
Saneron CCEL Therapeutics, Inc.
Buddhist Tzu Chi General Hospital
Investigators
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Study Director: Shinn-Zong Lin, M.D.;PhD. China Medical University Beigand Hospital, Taiwan
More Information
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Responsible Party: Shinn-Zong Lin, Professor of Neurosurgery, China Medical University hospital, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT02433509    
Other Study ID Numbers: CMUH101-IRB1-114
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Keywords provided by Shinn-Zong Lin, Buddhist Tzu Chi General Hospital:
acute ischemic stroke
umbilical cord blood
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia