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

Phase 1

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Other: HUCB monocyte cells

• Registration Number: NCT02433509
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-29
• Study Start: 2015-05
• Study First Posted: 2015-05-05
• Status Verified: 2021-11
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HUCB monocyte cells w/ Mannitol in acute ischemic stroke	HUCB monocyte cells	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 .

Primary Outcome Measures

Name	Time	Method
adverse events (AE)and serious adverse reaction(SAE)	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

Name	Time	Method
NIHSS	baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months	neurology functions change
Berg Balance score	baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months	motor function changes
abdominal sonography-spleen	baseline, after infusion 24, 72 hours, 3, 12months	size changes of spleen
Brain Image(MRI)	baseline, after infusion 24 hours, 1, 6, 12months	changes of Brain Images
Barthel Index	baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months	neurology function changes
cytokine family	baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months	for study
Blood examination	baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months	physical condition monitoring

Trial Locations

Locations (1)

Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Taiwan