Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
1 other identifier
interventional
3
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 stroke
Started Oct 2017
Shorter than P25 for phase_1 stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedStudy Start
First participant enrolled
October 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2018
CompletedDecember 7, 2018
December 1, 2018
1.1 years
June 3, 2016
December 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Neurological function
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
6 months
Study Arms (1)
GXNPC1
EXPERIMENTALThree 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant women
- Investigators with AIDS, cancer, liver dysfunction
- Others can't fit into the trial evaluate by investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Hsinchu, 30261, Taiwan
Hualien Tzu Chi Hospital
Hualien City, 97002, Taiwan
Related Publications (1)
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.
PMID: 34644444DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hualien T Hospital
Hualien Tzu Chi General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2016
First Posted
June 27, 2016
Study Start
October 19, 2017
Primary Completion
November 27, 2018
Study Completion
November 27, 2018
Last Updated
December 7, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share