NCT03629275终止2 期
A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects With Disability Following an Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 22
- 主要终点
- Proportion of subjects in which Modified Rankin Scale (mRS) improves by ≥1 point at Month 6 from Baseline
研究概览
简要总结
A study of stereotactic, intracerebral injection of CTX0E03 neural stem cells into patients with moderate to moderately severe disability as a result of an ischemic stroke.
详细描述
This is a randomized, placebo-controlled, multi-center study. Patients with persistent disability 6-24 months following an ischemic stroke will be enrolled following confirmation of eligibility. Patients will be randomized 2:1 to undergo a stereotactic surgery and receive a single administration of CTX0E03 Drug Product by intracerebral implantation or undergo sham surgery only (placebo). Patients will be followed for 12 months after surgery with follow-up assessments occurring at various time points over the 12 months. All eligible patients will be assigned a standardized Physical Therapy (PT) program. Patients will complete their daily PT exercises at home for 12 weeks after their surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke that includes the supratentorial region as confirmed by CT or MRI, occurring within 6 to 24 months of the time that surgical intervention will be performed (Qualifying Stroke Event)
- •Modified Rankin Score of 3 or 4 due to the Qualifying Stroke Event
- •Some residual upper limb movement
- •Sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
- •No medical conditions that would preclude neurosurgery with appropriate preparation and management.
- •Ability to attend study visits and complete all study assessments including ability to provide informed consent
排除标准
- •Modified Rankin Score of >1 prior to the Qualifying Stroke Event
- •Stroke due to hemorrhage or stroke known or suspected of being caused by, or related to, connective tissue disorder, congenital disorder of the cerebral vessels or a disorder of thrombosis; patients with atrial fibrillation as a suspected cause of stroke are NOT excluded
- •Neurosurgical pathway obstructed by vascular malformation or cavity
- •History of neurological or other disease resulting in significant functional impairment (e.g. Parkinson's disease, motor neuron disease, moderate dementia, arthritis, contractures or fixed anatomical abnormality)
- •Inability to stop or transition off valproic acid or other demethylating agents or Histone deacetylases (HDAC) inhibitors for 1 week before and 4 weeks after surgery
- •Use of selective serotonin reuptake inhibitors (SSRI), unless the subject is on a stable dose that has been started at least 2-months before screening (V1)
- •Use of antispasticity medications (excluding oral antispasticity medications if they have been taken regularly for at least one month prior to surgery)The use of Botox® or similar is allowed if the last dose was ≥3 months prior to screening; however, its use will be prohibited until following the 12 month visit
- •Inability to discontinue anticoagulation therapy for a required interval
- •History of malignant disease within the last 5 years, or any history of primary or secondary brain malignant disease
- •Patients who have previously participated in a cell-based therapy study at any time or in any other study involving an investigational product or rehabilitation study within the last 30 days
- •Patients with clinically significant lab values, including positive Class I human leukocyte antigen (HLA) antibodies specific for CTX0E03
- •Planned initiation of any new PT regimen within 6-months of surgery
研究组 & 干预措施
CTX0E03 Drug Product and delivery device
Experimental
20 million neural stem cells
干预措施: CTX0E03 Drug Product and delivery device (Combination Product)
Placebo
Sham Comparator
Sham Surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects in which Modified Rankin Scale (mRS) improves by ≥1 point at Month 6 from Baseline
时间窗: 6 months
The mRS is an ordinal scale from 0-6, where 0 represents no disability, and each grade above 0 represents a subject's increased level of disability and dependence upon others to perform daily activities.
次要结局
- Change from baseline in a subject's executive processing speed, language skills and memory using the Symbol Digit Modalities Test.(6 months)
- Change from baseline in a subject's executive processing speed, language skills and memory using the Multilingual Naming Test.(6 months)
- Change from baseline in a subject's executive processing speed, language skills and memory using the Montreal Cognitive Assessment.(6 months)
- Change from baseline in restoring a subject's motor function using the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA).(6 months)
- Change from baseline in a subject's ability to execute activities of daily living using the Barthel Index (BI).(6 months)
- Change from baseline in a subject's basic mobility and balance using the Timed Up and Go Test (TUG).(6 months)
- Change from baseline in a subject's neurological deficits using the National Institute of Health Stroke Scale (NIHSS).(6 months)
- Change from baseline in a subject's perception to stroke recovery using the Stroke Impact Scale (SIS).(6 months)
- Change from baseline in the function of subject's paretic limb using the Chedoke Arm and Hand Activity Inventory (CAHAI).(6 months)
- Change from baseline in a subject's executive processing speed, language skills and memory using Controlled Oral Word Association tasks.(6 months)
- Change from baseline in subject's global rating of change regarding their limitations of activity, symptoms, and overall quality of life.(6 months)
- Change from baseline in a subject's health-related quality of life using the EQ-5D-5L.(6 months)
- Safety: To assess the number and severity of adverse events and medical device incidents that occur over the study period.(12 months)
研究者
研究点 (22)
Loading locations...
相似试验
Unknown
1 期
Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic StrokeIschemic Motor Stroke, ChronicNCT03296618Suzhou Neuralstem Biopharmaceuticals18
撤回
1 期
Genetically Modified Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade GliomasAdult Anaplastic AstrocytomaAdult Anaplastic OligodendrogliomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaRecurrent Adult Brain TumorNCT02055196City of Hope Medical Center
已完成
1 期
Neural Stem Cell Transplantation in Multiple Sclerosis PatientsProgressive Multiple SclerosisNCT03269071IRCCS San Raffaele4
进行中（未招募）
1 期
An effectiveness and safety trial of CTX0E03 Drug Product injected into a patient's brain for the treatment of stable stroke due to reduced blood flow.Supratentorial ischaemic strokeMedDRA version: 20.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disordersEUCTR2012-003482-18-GBReNeuron Ltd21
已完成
2 期
Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic StrokeChronic Ischemic StrokeNCT02448641SanBio, Inc.163