Acute Ischemic StrokePhase 1NCT02433509
Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke
A Phase 1 study testing hUCB in people with Acute Ischemic Stroke, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- hUCB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2015to 14 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- hUCB
- Keywords
- acute ischemic stroke, umbilical cord blood
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hUCBOther
Also called 20% Mannnitol
- 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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Other: hUCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events (AE)and serious adverse reaction(SAE)
any AE or SAE (related or non-related) during the 12-month follow-up period
Measured: after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months.
Secondary outcomes (7)
Brain Image(MRI)
changes of Brain Images
Measured: baseline, after infusion 24 hours, 1, 6, 12months
abdominal sonography-spleen
size changes of spleen
Measured: baseline, after infusion 24, 72 hours, 3, 12months
NIHSS
neurology functions change
Measured: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Berg Balance score
motor function changes
Measured: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Barthel Index
neurology function changes
Measured: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Blood examination
physical condition monitoring
Measured: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months
cytokine family
for study
Measured: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2015
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- acute ischemic stroke
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Buddhist Tzu Chi General Hospital, StemCyte Taiwan Co., Ltd.
- Responsible party
- Principal investigator, Shinn-Zong Lin, Buddhist Tzu Chi General Hospital
- Investigators
- Shinn-Zong Lin, M.D.;PhD., Principal investigator, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433509
- Sponsor's protocol ID
- CMUH101-IRB1-114
- Status last verified
- Nov 2021
- First submitted
- 21 Apr 2015
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02433509
- Acronym / sponsor ID
- CMUH101-IRB1-114
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, umbilical cord blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Buddhist Tzu Chi General Hospital, StemCyte Taiwan Co., Ltd.
- Study start
- May 2015
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- acute ischemic stroke
| Arm | Type | Receives |
|---|---|---|
| hUCB w/ Mannitol in acute ischemic stroke | Experimental | Other: hUCB1. 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 . |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hUCBAlso: 20% Mannnitol1. 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 . | Other | hUCB w/ Mannitol in acute ischemic stroke |
Primary outcome
adverse events (AE)and serious adverse reaction(SAE)
Time frame: 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
7 secondary outcomes
Brain Image(MRI)
Time frame: baseline, after infusion 24 hours, 1, 6, 12months
abdominal sonography-spleen
Time frame: baseline, after infusion 24, 72 hours, 3, 12months
NIHSS
Time frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Berg Balance score
Time frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Barthel Index
Time frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months
Blood examination
Time frame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months
cytokine family
Time frame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shinn-Zong Lin, M.D.;PhD. principal investigator
Hualien Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hUCB in people with Acute Ischemic Stroke, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (AE)and serious adverse reaction(SAE) (time frame: after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.