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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: HUCB monocyte cells

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 Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shinn-Zong Lin, M.D.;PhD.; Email: shinnzong@yahoo.com.tw
• Study Contact Backup: Name: Shinn-Zong Lin, M.D.;PhD.; Phone Number: 13201 886-3-8561825; Email: shinnzong@yahoo.com.tw

Study Locations

• Taiwan
  • Hualien City, Taiwan, 707
    • Recruiting
    • Hualien Tzu Chi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HUCB monocyte cells w/ Mannitol in acute ischemic stroke; 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.; 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .	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 .; Other Names: 20% Mannnitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: University of South Florida; Buddhist Tzu Chi General Hospital; StemCyte, Inc.; Saneron CCEL Therapeutics, Inc.
• Investigators: Principal Investigator: Shinn-Zong Lin, M.D.;PhD., Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: acute ischemic stroke; umbilical cord blood
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: CMUH101-IRB1-114