The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.
The study will use CD34+ 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 5 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. We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
China Medical University Hospital
Taichung, Taiwan, Taiwan
Change from baseline in NIH Stroke Scale (NIHSS)
Evaluate change from Baseline in NIHSS at 1 week
Time frame: Change from baseline in NIHSS at 1 weeks
Change from Baseline in NIH Stroke Scale(NIHSS)
Evaluate change from Baseline in NIHSS at 2 weeks
Time frame: Change from Baseline in NIHSS at 2 weeks
Change from baseline in NIH Stroke Scale
Evaluate change from baseline in NIHSS at 4 weeks
Time frame: Change from baseline in NIHSS at 4 weeks
Change from baseline in NIH Stroke Scale ( NIHSS)
Evaluate change from baseline in NIHSS at 12 weeks
Time frame: Change from baseline in NIHSS at 12 weeks
Change from baseline in Brain Image
Brain Image will be performed by MRI. The MRI evaluation includes DEI, T1W, T2W, MRS, and DTI, and change from baseline will be evaluated at 1 week
Time frame: Change from baseline in Brain Image at 1 week
Change from baseline in Brain Image
Brain Image will be performed by MRI. The MRI evaluation includes DEI,T1W,T2W,MRS and DTI , and evaluate the change from baseline at 4 weeks
Time frame: Change from baseline in Brain Image at 4 weeks
Change from baseline in Brain Image
Brain Image will be performed by MRI.MRI image includes DEI,T1W, T2W, and DTI, and change from baseline will be evaluated at 6 months.
Time frame: Change from baseline in Brain Image at 6 months
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