Stroke
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGADSCs
Autologous ADSCs
Sponsors
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* stroke investigators with age 65 to 80 years * history of stroke between six months and 10 years * Systolic pressure and Diastolic pressure were maintained under 160 mmHg and 110 mmHg * INR \< 2.5, platelets counts 1-5 x 10\^5/μl * Damaged area range between 0.5 cm to 6 cm by brain MRI
Exclusion criteria
* Pregnant women * Investigators with AIDS, cancer, liver dysfunction * Others can't fit into the trial evaluate by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological function | 6 months | Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20) |
Countries
Taiwan
Outcome results
None listed