Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
Overview
- Phase
- Phase 1
- Intervention
- ADSCs
- Conditions
- Stroke
- Sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Neurological function
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
GXNPC1
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.
Intervention: ADSCs
Outcomes
Primary Outcomes
Neurological function
Time Frame: 6 months
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)