Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke
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ClinicalTrials.gov Identifier: NCT02433509 |
Recruitment Status :
Recruiting
First Posted : May 5, 2015
Last Update Posted : November 23, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Ischemic Stroke | Other: HUCB monocyte cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | acute ischemic stroke |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke |
Study Start Date : | May 2015 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: HUCB monocyte cells w/ Mannitol in acute ischemic stroke
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Other: HUCB monocyte cells
Other Name: 20% Mannnitol |
- 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
- Brain Image(MRI) [ Time Frame: baseline, after infusion 24 hours, 1, 6, 12months ]changes of Brain Images
- abdominal sonography-spleen [ Time Frame: baseline, after infusion 24, 72 hours, 3, 12months ]size changes of spleen
- NIHSS [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months ]neurology functions change
- Berg Balance score [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months ]motor function changes
- Barthel Index [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months ]neurology function changes
- Blood examination [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months ]physical condition monitoring
- cytokine family [ Time Frame: baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months ]for study

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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433509
Contact: Shinn-Zong Lin, M.D.;PhD. | shinnzong@yahoo.com.tw | ||
Contact: Shinn-Zong Lin, M.D.;PhD. | 886-3-8561825 ext 13201 | shinnzong@yahoo.com.tw |
Taiwan | |
Hualien Tzu Chi Hospital | Recruiting |
Hualien City, Taiwan, 707 |
Principal Investigator: | Shinn-Zong Lin, M.D.;PhD. | Buddhist Tzu Chi General Hospital |
Responsible Party: | Shinn-Zong Lin, Hualien Tzu Chi Medical Center, Buddhist Tzu Chi General Hospital |
ClinicalTrials.gov Identifier: | NCT02433509 |
Other Study ID Numbers: |
CMUH101-IRB1-114 |
First Posted: | May 5, 2015 Key Record Dates |
Last Update Posted: | November 23, 2021 |
Last Verified: | November 2021 |
acute ischemic stroke umbilical cord blood |
Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |