Trials / Completed
CompletedNCT02813512
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 65 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ADSCs | Autologous ADSCs |
Timeline
- Start date
- 2017-10-19
- Primary completion
- 2018-11-27
- Completion
- 2018-11-27
- First posted
- 2016-06-27
- Last updated
- 2018-12-07
Locations
2 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT02813512. Inclusion in this directory is not an endorsement.