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Completed

NCT Number: NCT02433509

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hualien Tzu Chi Hospital

Hualien City, Taiwan, 707

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

hUCB

Other
  • 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.
  • 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .

Other names: 20% Mannnitol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • Buddhist Tzu Chi General Hospital
  • StemCyte Taiwan Co., Ltd.

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
May 5, 2015
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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