Chronic StrokePhase 2NCT04088149
An Open-labeled Phase II Study to Evaluate the Efficacy and Safety of GXNPC-1 in Patients with Chronic Stroke
A Phase 2 study testing GXNPC1 in people with Chronic Stroke, run by Gwo Xi Stem Cell Applied Technology Co., Ltd. at 1 site in Taiwan.
Trial summary
The primary objective of this study is to evaluate the efficacy for subjects with chronic stroke after GXNPC-1 injection. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- GXNPC1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Feb 2020to 3 Sep 2024
- Phase
- Phase 2
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female who are aged between 45 and 85 years old on date of consent
- Post-stroke between 6 months and 15 years at the screening
- Subjects who have had stroke(s) in carotid artery distribution area, and the location of stroke should be diagnosed by magnetic resonance image (MRI)
- Subjects who have had the brain injured area with diameter between 0.5 and 10 cm according to MRI evaluation
- Subjects who have National Institutes of Health Stroke Scale (NIHSS) score between 8 and 30 at the screening
- Subjects who had stroke with hemiparesis (remaining residual limb movement, defined as score less than 4 on questions 5 or 6 on the NIHSS for the affected limbs) at screening.
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- Subjects who have stable NIHSS (±3) for at least 2 weeks from Visit 1 (screening) to Visit2 (prior to operation)
- Subjects with systolic blood pressure less than 200 mmHg (an average based on ≥2 readings) at screening, prior to the operation for fat tissue acquisition (Visit 2), and before the surgery for ADSC administration (Visit 3)
- Subjects with International normalized ration (INR) < 2.5, and platelet between 1 × 105/μL and 5 × 105/μL at the screening
- Female subjects with childbearing potential should be confirmed of not being pregnant or lactating at the screening and during the study.
- All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use reliable contraception method(s), such as tubal ligation, vasectomy, intrauterine device (IUD), intrauterine system (IUS), hormonal contraception or condom, during this study when they have sexual behavior.
- Neurology physician judges the recent symptoms in subjects are correlated to the stroke area.
- Subjects or the legally acceptable representative are willing to sign informed consent form (ICF).
Who cannot join
- Subjects who are suffered by clinically significantly autoimmune conditions, such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), multiple sclerosis (MS) or psoriasis
- Subjects who are unable to undergo MRI and Computed tomography (CT) scans for any reason
- Subjects who have significant multiple stenosis (>50% stenosis) in intracranial blood vessels
- Subjects whose cause of stroke belongs to uncommon causes (refer to Vasc Health Risk Manag. 2015:11 157-164), including but not limited to:
- Non-atherosclerotic angiopathies: cervicocephalic atrial dissection, cerebral amyloid angiopathy, fibromuscular dysplasia, and migraine-induced stroke, etc.;
- Hematologic conditions: hypercoagulable state due to deficiencies of protein C, protein S, or antithrombin, factor V Leiden mutation, prothrombin gene G20210Amutation, acquired hypercoagulable state, antiphospholipid syndrome, hyperhomocysteinemia, sickle cell disease, etc.;
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- Genetic: Fabry disease, CADASIL (cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy), MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes), Marfan syndrome, Neurofibromatosis, and Sturge-Weber Syndrome, etc.;
- Inflammatory and infectious: vasculitis (primary angilitis of the CNS, Sjögren syndrome, Wegener's granulomatosis), temporal arteritis, Takayasu disease, Behçet's syndrome, Neurosarcoidosis, Neurocysticercosis, varicella zoster virus, neurosyphilis, and tuberculous meningitis, etc.
- Subjects receiving antiplatelets (e.g., aspirin and persantin) and/or anticoagulants (e.g., warfarin) cannot temporarily cease the treatment within 3 days before ADSCs administration (Visit 3).
- Subjects who receive systemic immunosuppressive treatments, immunotherapy, or cytotoxic drug within 1 month before screening
- Subjects with inadequate hepatic function at the screening visit: Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST), and alkaline phosphatase (ALP) ≥ 2X upper limit of normal (ULN).
- Subjects with inadequate renal function at the screening visit: Blood urea nitrogen (BUN) ≥ 30 mg/dl; serum creatinine ≥ 3 mg/dl
- Subjects who have medical historical or clinically active spinal injury, Alzheimer's disease, Parkinson's disease, spinocerebellar ataxia (SCA), spinal muscular atrophy (SMA) or other clinically significant neurological diseases that will confound the evaluation of this study
- Subjects who have clinically severe and/or life-threatening disease(s) such as uncontrolled diabetes or malignant tumor
- Subjects who have risk for the following infectious diseases: human immunodeficiency virus (HIV), syphilis, or human transmissible spongiform encephalopathy (TSE), such as Creutzfeldt-Jakob disease (CJD)
- Subject who fails to generate adequate amount of ADSCs before administration at Visit 3
- Female subject who is lactating, pregnant, or planned to be pregnant
- Subject with known or suspected hypersensitivity to GXNPC-1 or its excipients
- Subject with any complication by chest X-ray and electrocardiogram (ECG) evaluation
- Subjects who have participated in other investigational studies and received any treatment within 4 weeks prior to screening
- Subjects not suitable to participate the trial as judged by the investigator(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GXNPC1 Injections for Chronic Stroke
The primary objective of this study is to evaluate the efficacy for subjects with chronic stroke after GXNPC-1 injection.
Read the detailed description
This is an open-label, single center, sequentially study in subjects with chronic stroke. Considering 20% dropout rate (based on evaluable versus treated patients), approximately 15 subjects will be enrolled, and at least 12 subjects will be evaluable. Cohort 1 will recruit the first 3 evaluable subjects assigned to receive low dose of GXNPC-1. The following 3 evaluable subjects will be enrolled sequentially and treated with high dose of GXNPC-1 in cohort 2. In cohort 3, another 6 evaluable subjects will be enrolled to take high dose of GXNPC-1. There will be 2 parts of this study including GXNPC-1 preparation and GXNPC-1 treatment in chronic stroke subjects, respectively.
- Conditions
- Chronic Stroke
- Being tested
- GXNPC1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GXNPC1Drug
Also called hADSCs
Autologous ADSCs
| Study group | Role | What they receive |
|---|---|---|
| GXNPC1 | Experimental | There are 2 dose levels Cohort 1: Low dose (1 ± 0.1 × 10^8 GXNPC1) of IPs will be administered in parallel.
Cohort 2: High dose (2 ± 0.2 × 10^8 GXNPC1) of IPs will be administered sequentially. Receives: Drug: GXNPC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Net Change on National Institutes of Health Stroke Scale (NIHSS)
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is used to evaluate the effect of stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The NIHSS is consisted of 11 evaluable items, and the total scores range from 0 to 42. The lower score indicates the better the performance.
Measured: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
Secondary outcomes (8)
The Net Change on Fugl-Meyer assessment (FMA)
The FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in subjects with post-stroke hemiplegia. The higher score, the better the performance.The scale is comprised of five domains and there are 155 items in total:
- Motor functioning (in the upper and lower extremities)
- Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints)
- Balance (contains 7 tests, 3 seated and 4 standing)
- Joint range of motion (8 joints)
- Joint pain
Measured: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Barthel Index (BI)
The BI is a well-known scoring tool to measure the subject's performance in 10 activities of daily life. The items can be divided into a group that is related to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and a group related to mobility (ambulation, transfers, and stair climbing). The maximal score is 100, indicating that the patient is fully independent in physical functioning. The lowest score is 0, representing a totally dependent bedridden state.
Measured: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Purdue Pegboard Test (PPT)
The Purdue Pegboard Test (PPT) is a test of fingertip dexterity and gross movement of the hand, fingers and arm in patients with impairments of the upper extremity resulting from neurological and musculoskeletal conditions.
Measured: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Grip Strength Measurement
The Grip Strength Measurement is to measure the maximum isometric strength of the hand and forearm muscles. Grip strength is measured using an instrument called a dynamometer.
Measured: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Brief Symptom Rating Scale (BSRS-5)
The BSRS-5 contains five items of psychological symptoms and is commonly used for screening psychological disorders. The maximal score of each item is 4, indicating that the subject is fully suffered from the problem.
Measured: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
Incidence of Adverse event (AE)
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered GXNPC-1 and which does not necessarily have to have a causal relationship with this treatment.
Measured: 0-24 weeks
Incidence of ≥Grade 2 Common Terminology Criteria for Adverse Events (CTCAE)
Incidence of ≥Grade 2 Common Terminology Criteria for Adverse Events (CTCAE; version 5.0) belonging to nervous system and generalized muscle weakness.
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting ageappropriate instrumental activities of daily living.
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living.
- Grade 4: Life-threatening consequences; urgent intervention indicated.
- Grade 5: Death related to AE.
Measured: 0-24 weeks
Incidence of subjects experiencing Serious adverse events (SAEs) or Suspected Unexpected Serious Adverse Reaction (SUSAR).
SAEs include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. SUSAR is the term used to refer to any unfavourable occurrence in a trial participant that is judged to have a major impact on their health, was not anticipated.
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start6 Feb 2020
- Primary completion15 Aug 2023
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- Chiu Ts Lang, Director, Principal investigator, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088149
- Sponsor's protocol ID
- GXNPC1
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GXNPC1 Injections for Chronic Stroke
- ClinicalTrials.gov ID
- NCT04088149
- Acronym / sponsor ID
- GXNPC1
- Conditions
- Chronic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 12 Sep 2019 (actual)
- 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 primary objective of this study is to evaluate the efficacy for subjects with chronic stroke after GXNPC-1 injection.
Detailed description
This is an open-label, single center, sequentially study in subjects with chronic stroke. Considering 20% dropout rate (based on evaluable versus treated patients), approximately 15 subjects will be enrolled, and at least 12 subjects will be evaluable. Cohort 1 will recruit the first 3 evaluable subjects assigned to receive low dose of GXNPC-1. The following 3 evaluable subjects will be enrolled sequentially and treated with high dose of GXNPC-1 in cohort 2. In cohort 3, another 6 evaluable subjects will be enrolled to take high dose of GXNPC-1. There will be 2 parts of this study including GXNPC-1 preparation and GXNPC-1 treatment in chronic stroke subjects, respectively.
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: GXNPC1There are 2 dose levels Cohort 1: Low dose (1 ± 0.1 × 10^8 GXNPC1) of IPs will be administered in parallel. Cohort 2: High dose (2 ± 0.2 × 10^8 GXNPC1) of IPs will be administered sequentially. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female who are aged between 45 and 85 years old on date of consent
- Post-stroke between 6 months and 15 years at the screening
- Subjects who have had stroke(s) in carotid artery distribution area, and the location of stroke should be diagnosed by magnetic resonance image (MRI)
- Subjects who have had the brain injured area with diameter between 0.5 and 10 cm according to MRI evaluation
- Subjects who have National Institutes of Health Stroke Scale (NIHSS) score between 8 and 30 at the screening
Key exclusion criteria (21 listed)
- Subjects who are suffered by clinically significantly autoimmune conditions, such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), multiple sclerosis (MS) or psoriasis
- Subjects who are unable to undergo MRI and Computed tomography (CT) scans for any reason
- Subjects who have significant multiple stenosis (>50% stenosis) in intracranial blood vessels
- Subjects whose cause of stroke belongs to uncommon causes (refer to Vasc Health Risk Manag. 2015:11 157-164), including but not limited to:
- Subjects receiving antiplatelets (e.g., aspirin and persantin) and/or anticoagulants (e.g., warfarin) cannot temporarily cease the treatment within 3 days before ADSCs administration (Visit 3).
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 |
|---|---|---|
| GXNPC1Also: hADSCsAutologous ADSCs | Drug | GXNPC1 |
Primary outcome
The Net Change on National Institutes of Health Stroke Scale (NIHSS)
Time frame: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is used to evaluate the effect of stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The NIHSS is consisted of 11 evaluable items, and the total scores range from 0 to 42. The lower score indicates the better the performance.
8 secondary outcomes
The Net Change on Fugl-Meyer assessment (FMA)
Time frame: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Barthel Index (BI)
Time frame: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Purdue Pegboard Test (PPT)
Time frame: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Grip Strength Measurement
Time frame: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Brief Symptom Rating Scale (BSRS-5)
Time frame: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
Incidence of Adverse event (AE)
Time frame: 0-24 weeks
Incidence of ≥Grade 2 Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 0-24 weeks
Incidence of subjects experiencing Serious adverse events (SAEs) or Suspected Unexpected Serious Adverse Reaction (SUSAR).
Time frame: 0-24 weeks
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 19 Sep 2024.
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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.
Chiu Ts Lang, Director principal investigator
Hualien Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GXNPC1 in people with Chronic Stroke, run by Gwo Xi Stem Cell Applied Technology Co., Ltd. at 1 site 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 13 inclusion and 21 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The Net Change on National Institutes of Health Stroke Scale (NIHSS) (time frame: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.