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

NCT02433509 | Completed Phase 1 DMC

• 1 other identifier: CMUH101-IRB1-114
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; umbilical cord blood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Brain Image(MRI)

  baseline, after infusion 24 hours, 1, 6, 12months

• abdominal sonography-spleen

  baseline, after infusion 24, 72 hours, 3, 12months

• NIHSS

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

• Berg Balance score

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

• Barthel Index

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

Study Arms (1)

hUCB w/ Mannitol in acute ischemic stroke

EXPERIMENTAL

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 .

Other: hUCB

Interventions

hUCB OTHER

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 .

Also known as: 20% Mannnitol

hUCB w/ Mannitol in acute ischemic stroke

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age of Subjects between 45 through 80 years.
• Acute Ischemic Stroke.
• National Institutes of Health Stroke Scale (NIHSS):6-18
• Brain MRI shows the middle cerebral artery region (M1 and M2) of cerebral i infarction stroke patients.
• Subjects have no midline shift or hemorrhagic transformation

You may not qualify if:

• NIHSS score reduced more than 4 within after 24 hours.
• Female are pregnant or lactating.
• Subjects with impaired liver function, AIDS, cancer or other significant medical condition (including certifiable diseases, rare disease)
• Subjects joined other clinical trails or received rt-PA therapy.
• Immune dysfunction or receiving other immunosuppressive agents.
• Subjects cannot have MRI test
• Subjects' HLA typing results match less than 4 out of the 6 genotypes

Sponsors & Collaborators

• China Medical University Hospital: lead
• Buddhist Tzu Chi General Hospital: collaborator
• StemCyte Taiwan Co., Ltd.: collaborator

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Taiwan, 707, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shinn-Zong Lin, M.D.;PhD.

  Buddhist Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hualien Tzu Chi Medical Center

Model Details: acute ischemic stroke

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 5, 2015
• Study Start: May 1, 2015
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: August 6, 2025

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)