StrokePhase 1NCT02813512
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
A Phase 1 study testing ADSCs in people with Stroke, run by Gwo Xi Stem Cell Applied Technology Co., Ltd. at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- ADSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesTaiwan
- Study dates
- 19 Oct 2017to 27 Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Investigators with AIDS, cancer, liver dysfunction
- Others can't fit into the trial evaluate by investigator
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Hsinchu, 30261
Hualien Tzu Chi Hospital
Hualien City, 97002
About this study
Official title: Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
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).
Read the 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
- Stroke
- Being tested
- ADSCs
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSCsDrug
Also called hADSCs
Autologous ADSCs
| Study group | Role | What they receive |
|---|---|---|
| GXNPC1 | Experimental | 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. Receives: Drug: ADSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological function
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start19 Oct 2017
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hualien T Hospital, Principal investigator, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813512
- Sponsor's protocol ID
- CMUH102-REC1-034
- Status last verified
- Dec 2018
- First submitted
- 3 Jun 2016
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34644444
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
- ClinicalTrials.gov ID
- NCT02813512
- Acronym / sponsor ID
- CMUH102-REC1-034
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GXNPC1 | Experimental | Drug: ADSCsThree 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant women
- Investigators with AIDS, cancer, liver dysfunction
- Others can't fit into the trial evaluate by investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADSCsAlso: hADSCsAutologous ADSCs | Drug | GXNPC1 |
Primary outcome
Neurological function
Time frame: 6 months
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Derived from this study: PubMed 34644444Chiu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hualien T Hospital principal investigator
Hualien Tzu Chi General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADSCs in people with Stroke, run by Gwo Xi Stem Cell Applied Technology Co., Ltd. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.