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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02433509
• Other study ID #: CMUH101-IRB1-114
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2021
• Source: China Medical University Hospital
• Contact: Shinn-Zong Lin, M.D.;PhD.
• Email: shinnzong[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• HUCB monocyte cells
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 .

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital	Hualien City

Sponsors (5)

Lead Sponsor	Collaborator
China Medical University Hospital	Buddhist Tzu Chi General Hospital, Saneron CCEL Therapeutics, Inc., StemCyte, Inc., University of South Florida

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events (AE)and serious adverse reaction(SAE)	any AE or SAE (related or non-related) during the 12-month follow-up period	after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months.
Secondary	Brain Image(MRI)	changes of Brain Images	baseline, after infusion 24 hours, 1, 6, 12months
Secondary	abdominal sonography-spleen	size changes of spleen	baseline, after infusion 24, 72 hours, 3, 12months
Secondary	NIHSS	neurology functions change	baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Secondary	Berg Balance score	motor function changes	baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Secondary	Barthel Index	neurology function changes	baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Secondary	Blood examination	physical condition monitoring	baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months
Secondary	cytokine family	for study	baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months