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

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
HUCB monocyte cells
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke, umbilical cord blood

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hualien Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HUCB monocyte cells w/ Mannitol in acute ischemic stroke

Arm Description

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 .

Outcomes

Primary Outcome Measures

adverse events (AE)and serious adverse reaction(SAE)
any AE or SAE (related or non-related) during the 12-month follow-up period

Secondary Outcome Measures

Brain Image(MRI)
changes of Brain Images
abdominal sonography-spleen
size changes of spleen
NIHSS
neurology functions change
Berg Balance score
motor function changes
Barthel Index
neurology function changes
Blood examination
physical condition monitoring
cytokine family
for study

Full Information

First Posted
April 21, 2015
Last Updated
November 22, 2021
Sponsor
China Medical University Hospital
Collaborators
StemCyte, Inc., University of South Florida, Saneron CCEL Therapeutics, Inc., Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02433509
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
Collaborators
StemCyte, Inc., University of South Florida, Saneron CCEL Therapeutics, Inc., Buddhist Tzu Chi General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
acute ischemic stroke, umbilical cord blood

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
acute ischemic stroke
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HUCB monocyte cells w/ Mannitol in acute ischemic stroke
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
HUCB monocyte cells
Other Intervention Name(s)
20% Mannnitol
Intervention Description
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 .
Primary Outcome Measure Information:
Title
adverse events (AE)and serious adverse reaction(SAE)
Description
any AE or SAE (related or non-related) during the 12-month follow-up period
Time Frame
after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months.
Secondary Outcome Measure Information:
Title
Brain Image(MRI)
Description
changes of Brain Images
Time Frame
baseline, after infusion 24 hours, 1, 6, 12months
Title
abdominal sonography-spleen
Description
size changes of spleen
Time Frame
baseline, after infusion 24, 72 hours, 3, 12months
Title
NIHSS
Description
neurology functions change
Time Frame
baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Title
Berg Balance score
Description
motor function changes
Time Frame
baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Title
Barthel Index
Description
neurology function changes
Time Frame
baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Title
Blood examination
Description
physical condition monitoring
Time Frame
baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months
Title
cytokine family
Description
for study
Time Frame
baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shinn-Zong Lin, M.D.;PhD.
Email
shinnzong@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Shinn-Zong Lin, M.D.;PhD.
Phone
886-3-8561825
Ext
13201
Email
shinnzong@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinn-Zong Lin, M.D.;PhD.
Organizational Affiliation
Buddhist Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
ZIP/Postal Code
707
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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