Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
This trial is active, not recruiting.
|Treatment||human umbilical cord mesenchymal stem cells|
|Sponsor||Shenzhen Hornetcorn Bio-technology Company, LTD|
|Collaborator||The Fifth Affiliated Hospital of Guangzhou Medical University|
|Start date||March 2015|
|End date||December 2016|
|Trial size||20 participants|
|Trial identifier||NCT02283879, HYK-Cerebral hemorrhage|
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
time frame: 12 months
Improvement of infarct size measured by brain MRI
time frame: before the transplant and 1, 6, 12 months after transplantation
Modified Barthel index
time frame: before and 1, 3, 6 and 12 months after transplantation
National Institutes of Health stroke scale(NIHSS) score
time frame: before the transplant and after the transplant 1, 2 and 3 months
Male or female participants from 40 years up to 80 years old.
Inclusion Criteria: - Aged 40-70 intracerebral hemorrhage patient - With stroke history of more than 3 months, less than 60 months - National Institutes of Health stroke scale(NIHSS) score of 7 or more points - Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.) Exclusion Criteria: - History of neurological disease, head injury or psychiatric disorder; - Pregnant women; - Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition; - Progressive apoplexy; - With malignant tumors.
|Official title||Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage|
|Principal investigator||Ping J Chen, Professor|
|Description||Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage. To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.|
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