Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
ADSCs
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
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
Sites / Locations
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
- Hualien Tzu Chi Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GXNPC1
Arm Description
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.
Outcomes
Primary Outcome Measures
Neurological function
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
Secondary Outcome Measures
Full Information
NCT ID
NCT02813512
First Posted
June 3, 2016
Last Updated
December 6, 2018
Sponsor
Gwo Xi Stem Cell Applied Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02813512
Brief Title
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
Official Title
Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gwo Xi Stem Cell Applied Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GXNPC1
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
ADSCs
Other Intervention Name(s)
hADSCs
Intervention Description
Autologous ADSCs
Primary Outcome Measure Information:
Title
Neurological function
Description
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hualien T Hospital
Organizational Affiliation
Hualien Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gwo Xi Stem Cell Applied Technology Co., Ltd.
City
Hsinchu
ZIP/Postal Code
30261
Country
Taiwan
Facility Name
Hualien Tzu Chi Hospital
City
Hualien city
ZIP/Postal Code
97002
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34644444
Citation
Chiu TL, Baskaran R, Tsai ST, Huang CY, Chuang MH, Syu WS, Harn HJ, Lin YC, Chen CH, Huang PC, Wang YF, Chuang CH, Lin PC, Lin SZ. Intracerebral transplantation of autologous adipose-derived stem cells for chronic ischemic stroke: A phase I study. J Tissue Eng Regen Med. 2022 Jan;16(1):3-13. doi: 10.1002/term.3256. Epub 2021 Oct 21.
Results Reference
derived
Learn more about this trial
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
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