A Phase 2 interventional study of CTX0E03 Drug Product and delivery device and Placebo in Ischemic Stroke, Chronic Stroke and Hemiparesis, sponsored by ReNeuron Limited. Terminated at 23 sites in United States. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-13.
Sponsored by ReNeuron Limited · Phase 2, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →ReNeuron Limited is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20 million neural stem cells
Combination Product: CTX0E03 Drug Product and delivery device
Sham Surgery
Drug: Placebo
Includes stereotactic surgery and a burr hole drilled through the skull to allow for a one time intracerebral injection of 20 million CTX0E03 Drug Product stem cells into an area of the brain adjacent to the area affected by the stroke.
Sham surgical comparator includes stereotactic surgery and a partial thickness burr hole drilled into the skull. No injection of any kind is made into the brain, and no other intervention is given.
Proportion of subjects in which Modified Rankin Scale (mRS) improves by ≥1 point at Month 6 from Baseline
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.
Time frame: 6 months
Change from baseline in a subject's ability to execute activities of daily living using the Barthel Index (BI).
The BI is an ordinal scale used to measure a patient's ability to perform activities of daily living. Sum scores from 10 items are calculated with total possible scores ranging from 0-100, with lower scores indicating increased disability.
Time frame: 6 months
Change from baseline in a subject's basic mobility and balance using the Timed Up and Go Test (TUG).
TUG is a timed activity assessing mobility and balance in which subjects are asked to stand up from a chair, walk a distance of 3 meters, turn around, walk back to chair and seat themselves. Scores consist of time taken to complete the activity, in seconds.
Time frame: 6 months
Change from baseline in the function of subject's paretic limb using the Chedoke Arm and Hand Activity Inventory (CAHAI).
The CAHAI is validated to assess paretic limb function and consists of 13 functional tasks, each scored on a 7-point scale, with total test scores obtained by summing each task score. Total scores can range from 13-91 with higher scores indicating greater ability.
Time frame: 6 months
Change from baseline in a subject's executive processing speed, language skills and memory using the Symbol Digit Modalities Test.
Validated test assessing different aspects of cognitive function.
Time frame: 6 months
Change from baseline in a subject's executive processing speed, language skills and memory using Controlled Oral Word Association tasks.
Validated test assessing different aspects of cognitive function.
Time frame: 6 months
Change from baseline in a subject's executive processing speed, language skills and memory using the Multilingual Naming Test.
Validated test assessing different aspects of cognitive function.
Time frame: 6 months
Change from baseline in a subject's executive processing speed, language skills and memory using the Montreal Cognitive Assessment.
Validated test assessing different aspects of cognitive function.
Time frame: 6 months
Change from baseline in a subject's neurological deficits using the National Institute of Health Stroke Scale (NIHSS).
The NIHSS is comprised of 15 items used to assess severity of impairment due to stroke with each item scored on a 3 or 4 point ordinal scale in which 0 represents no impairment. Total sum score range from 0-42: higher score reflects greater severity.
Time frame: 6 months
Change from baseline in restoring a subject's motor function using the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA).
The FMA is used to assess motor function in post-stroke, hemiplegic patients. The FMA is comprised of 5 sections, and respective items within each section are scored using a 3-point ordinal scale with 0 representing inability to perform task. Total possible score is 226.
Time frame: 6 months
Change from baseline in subject's global rating of change regarding their limitations of activity, symptoms, and overall quality of life.
Self-administered 2 factor questionnaire assessing change in limitations of activity, symptoms, and overall quality of life.
Time frame: 6 months
Change from baseline in a subject's perception to stroke recovery using the Stroke Impact Scale (SIS).
The SIS is a stroke-specific, comprehensive measure of health status. The SIS is comprised of 59 items with each item rated on a 5 point Likert scale in terms difficulty. A score of 1 represents an inability to complete an item, where a score of 5 represents no difficulty.
Time frame: 6 months
Change from baseline in a subject's health-related quality of life using the EQ-5D-5L.
Subjects rate each of 5 dimensions with a numerical rating (1-5) where 1 represents no difficulty to 5 representing an inability, and where a lower total score represents better quality of life.
Time frame: 6 months
Safety: To assess the number and severity of adverse events and medical device incidents that occur over the study period.
Time frame: 12 months
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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ReNeuron Limited