Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (1)

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.
Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks

Secondary Outcomes (8)

The Net Change on Fugl-Meyer assessment (FMA)
Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Barthel Index (BI)
Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Purdue Pegboard Test (PPT)
Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Grip Strength Measurement
Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
The Net Change on Brief Symptom Rating Scale (BSRS-5)
Baseline (0 week)、2 weeks、4 weeks、12 weeks、24 weeks
+3 more secondary outcomes

Study Arms (1)

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.

Drug: GXNPC1

Interventions

GXNPC1Drug

Autologous ADSCs

Also known as: hADSCs

GXNPC1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age45 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Gwo Xi Stem Cell Applied Technology Co., Ltd.
Industrylead

Study Sites (1)

HualienTzu Chi Hospital

Hualien City, 700, Taiwan

Study Officials

Chiu Ts Lang, Director
Hualien Tzu Chi General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

February 6, 2020

Actual (reported)

You may not qualify if:

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.;
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)
+6 more criteria

An Open-labeled Phase II Study to Evaluate the Efficacy and Safety of GXNPC-1 in Patients with Chronic Stroke

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

GXNPC1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

GXNPC1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations