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

China Medical University Hospital6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

hUCBOTHER

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 .

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hualien Tzu Chi Hospital

Hualien City, Taiwan, Taiwan

Outcomes

Primary Outcomes

adverse events (AE)and serious adverse reaction(SAE)

any AE or SAE (related or non-related) during the 12-month follow-up period

Time frame: after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months.

Secondary Outcomes

Brain Image(MRI)

changes of Brain Images

Time frame: baseline, after infusion 24 hours, 1, 6, 12months

abdominal sonography-spleen

size changes of spleen

Time frame: baseline, after infusion 24, 72 hours, 3, 12months

NIHSS

neurology functions change

Time frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months

Berg Balance score

motor function changes

Time frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months

Barthel Index

neurology function changes

Time frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months

Blood examination

physical condition monitoring

Time frame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months

cytokine family

for study

Time frame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months

Data from ClinicalTrials.gov

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