Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
Phase 1
- Conditions
- Cerebral Hemorrhage
- Interventions
- Biological: Human umbilical cord mesenchymal stem cells
- Registration Number
- NCT02283879
- Lead Sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description hUC-MSC treatment Human umbilical cord mesenchymal stem cells Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
- Primary Outcome Measures
Name Time Method Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs) 12 months
- Secondary Outcome Measures
Name Time Method Improvement of infarct size measured by brain MRI before the transplant and 1, 6, 12 months after transplantation National Institutes of Health stroke scale(NIHSS) score before the transplant and after the transplant 1, 2 and 3 months Modified Barthel index before and 1, 3, 6 and 12 months after transplantation
Trial Locations
- Locations (1)
The Fifth Affiliated Hospital Immunotherapy center
🇨🇳Guangzhou, Guangdong, China