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

Recruiting

Phase 1 Results N/A

Update History

19 Apr '17
The gender criteria for eligibility was updated to "All."
18 Dec '15
The Summary of Purpose was updated.
New
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.
Old
The objective of the study is to determine the safely and efficacy of Intravenous transplants of Human Umbilical Cord Blood Monocyte in the treatment of Acute ischemic stroke patients.
The description was updated.
New
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 6 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.
Old
The study will use Monocyte 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 6 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 inject the cells by Intravenous in Acute ischemic stroke patients.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. The age of Subjects between 45 through 80 years. 2. Acute Ischemic Stroke. 3. National Institutes of Health Stroke Scale (NIHSS):8-18(left brain ) or 8-15(right brain ) 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 12~24 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 6 out of the 6 genotypes
Old
Inclusion Criteria: - Subjects can be of either gender and must be between 45 through 80 years of age. - Acute Ischemic Stroke - Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 8-18 (left brain stroke) and 8-15 ( right brain stroke). - Brain MRI results for the middle cerebral artery region (M1 and M2) of cerebral infarction stroke patients - Subjects has No midline shift or hemorrhagic transfomation Exclusion Criteria: - Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory. - Pregnant or lactating women. - Subjects must not have the following conditions in documents: - significant renal, cardiovascular, hepatic, or psychiatric disease - abnormal blood coagulation parameters, - immunodeficiency (e.g. AIDS) - tumors, leukemia, and other cancer that may interfere with the clinical trial protocol - infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation. - Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study. - Reduce NIHSS score more than 4 within after 12~24 hours. - HLA matching result is less than 6/6 of umbilical cord blood
13 Nov '15
Trial name was updated.
New
Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke
The eligibility criteria were updated.
New
Inclusion Criteria: - Subjects can be of either gender and must be between 45 through 80 years of age. - Acute Ischemic Stroke - Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 8-18 (left brain stroke) and 8-15 ( right brain stroke). - Brain MRI results for the middle cerebral artery region (M1 and M2) of cerebral infarction stroke patients - Subjects has No midline shift or hemorrhagic transfomation Exclusion Criteria: - Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory. - Pregnant or lactating women. - Subjects must not have the following conditions in documents: - significant renal, cardiovascular, hepatic, or psychiatric disease - abnormal blood coagulation parameters, - immunodeficiency (e.g. AIDS) - tumors, leukemia, and other cancer that may interfere with the clinical trial protocol - infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation. - Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study. - Reduce NIHSS score more than 4 within after 12~24 hours. - HLA matching result is less than 6/6 of umbilical cord blood
Old
Inclusion Criteria: - Subjects can be of either gender and must be between 40 through 80 years of age. - Acute Ischemic Stroke - Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 2-18 (left brain stroke) and 2-15 ( right brain stroke). - Brain MRI results for the middle cerebral artery region (M1 and M2) of cerebral infarction stroke patients - Subjects has No midline shift or hemorrhagic transfomation Exclusion Criteria: - Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory. - Pregnant or lactating women. - Subjects must not have the following conditions in documents: - significant renal, cardiovascular, hepatic, or psychiatric disease - abnormal blood coagulation parameters, - immunodeficiency (e.g. AIDS) - tumors, leukemia, and other cancer that may interfere with the clinical trial protocol - infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation. - Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study. - NIHSS recover more than 4 within 12~24 hours. - HLA matching result is less than 6/6 of umbilical cord blood
10 Nov '15
The Summary of Purpose was updated.
New
The objective of the study is to determine the safely and efficacy of Intravenous transplants of Human Umbilical Cord Blood Monocyte in the treatment of Acute ischemic stroke patients.
Old
The objective of the study is to determine the safely and efficacy of Intravenous transplants of Human Umbilical Cord Blood Monocyte in the treatment of Acute ischemic stroke patients.
The minimum age criteria for eligibility was updated to "45 Years."
The eligibility criteria were updated.
New
Inclusion Criteria: - Subjects can be of either gender and must be between 40 through 80 years of age. - Acute Ischemic Stroke - Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 2-18 (left brain stroke) and 2-15 ( right brain stroke). - Brain MRI results for the middle cerebral artery region (M1 and M2) of cerebral infarction stroke patients - Subjects has No midline shift or hemorrhagic transfomation Exclusion Criteria: - Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory. - Pregnant or lactating women. - Subjects must not have the following conditions in documents: - significant renal, cardiovascular, hepatic, or psychiatric disease - abnormal blood coagulation parameters, - immunodeficiency (e.g. AIDS) - tumors, leukemia, and other cancer that may interfere with the clinical trial protocol - infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation. - Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study. - NIHSS recover more than 4 within 12~24 hours. - HLA matching result is less than 6/6 of umbilical cord blood
Old
Inclusion Criteria: - Subjects can be of either gender and must be between 65 through 80 years of age. - Subjects must have had ischemic stroke between 24 through 72 hours ago. - Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 16-24. - Subjects must have stroke in the middle cerebral artery territory. - Subjects must be able to read and understand the informed consent form that has been approved by the appropriate Institutional Review Board (IRB). The subject must sign and date the informed consent form before any study-specific procedures. (Note: If a subject consents to participation but is not in a position to sign and date the informed consent form personally because of his or her physical conditions, the consent form must be confirmed orally at the time of consent, marked or finger printed by the subject voluntarily). The informed consent procedure must be observed by an independent witness who is present throughout the whole informed consent process and sign the consent form. Exclusion Criteria: - Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory. - Pregnant or lactating women. - Subjects must not have the following conditions in documents: - significant renal, cardiovascular, hepatic, or psychiatric disease - abnormal blood coagulation parameters, - immunodeficiency (e.g. AIDS) - tumors, leukemia, and other cancer that may interfere with the clinical trial protocol - infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation. - Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study.
14 May '15
A location was updated in Beigang.
New
The overall status was updated to "Recruiting" at China Medical University Beigang Hospital.