Clinical trial NCT02433509: Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke
Official title: Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
umbilical cord blood
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Buddhist Tzu Chi General Hospital
name: StemCyte Taiwan Co., Ltd.
First posted: 2015-05-05
Enrollment: 6
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: acute ischemic stroke
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: adverse events (AE)and serious adverse reaction(SAE)
timeFrame: after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months.
Secondary outcomes:
measure: Brain Image(MRI)
timeFrame: baseline, after infusion 24 hours, 1, 6, 12months
measure: abdominal sonography-spleen
timeFrame: baseline, after infusion 24, 72 hours, 3, 12months
measure: NIHSS
timeFrame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
measure: Berg Balance score
timeFrame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
measure: Barthel Index
timeFrame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
measure: Blood examination
timeFrame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months
measure: cytokine family
timeFrame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
Study officials:
affiliation: Buddhist Tzu Chi General Hospital
name: Shinn-Zong Lin, M.D.;PhD.
role: PRINCIPAL_INVESTIGATOR
References: