A Phase 1 interventional study of ADSCs in Stroke, sponsored by Gwo Xi Stem Cell Applied Technology Co., Ltd.. Completed at 2 sites in Taiwan. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-07.
Sponsored by Gwo Xi Stem Cell Applied Technology Co., Ltd. · Phase 1, Interventional, and Treatment
The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects who have chronic non-hemorrhagic stroke (>6 months).
This open-label clinical trial will compare outcomes of subjects with chronic stroke. Six subjects will be to treatment (n=3) groups. The treatment group will receive brain transplants of autologous ADSCs. Treatment group will receive rehabilitation after the transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and eight standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), ( Barthel Index )、 ( Berg balance scale )、 (Fugl - Meyer test )、(Action research arm test )、 (Purdue pegboard )、 ( grip strength measurement ) 、(somatosensory evoked potential, SSEP) at 1 month, 3 months, and 6 months after treatment.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Gwo Xi Stem Cell Applied Technology Co., Ltd. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Three subjects will be to treatment (n=3) groups. The treatment group will receive brain transplants of autologous ADSCs. Treatment group will receive rehabilitation after the transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and four standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), European Stroke Scale (ESS), European Stroke Motor Subscale (EMS), Barthel Index, MMSE and Gait analyses at 1 month, 3 months, and 6 months after treatment.
Drug: ADSCs
Autologous ADSCs
Also known as: hADSCs
Neurological function
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Gwo Xi Stem Cell Applied Technology Co., Ltd.