The primary objective of this study is to evaluate the efficacy for subjects with chronic stroke after GXNPC-1 injection.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Autologous ADSCs
HualienTzu Chi Hospital
Hualien City, Taiwan
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.
Time frame: Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
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: 1. Motor functioning (in the upper and lower extremities) 2. Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints) 3. Balance (contains 7 tests, 3 seated and 4 standing) 4. Joint range of motion (8 joints) 5. Joint pain
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0-24 weeks