Investigation of Neural Stem Cells in Ischemic Stroke (PISCES III)
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|ClinicalTrials.gov Identifier: NCT03629275|
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Chronic Stroke Hemiparesis Arm Paralysis||Combination Product: CTX0E03 Drug Product and delivery device Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects With Disability Following an Ischemic Stroke|
|Actual Study Start Date :||August 31, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: CTX0E03 Drug Product and delivery device
20 million neural stem cells
Combination Product: CTX0E03 Drug Product and delivery device
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 Comparator: Placebo
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 [ Time Frame: 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.
- Change from baseline in a subject's ability to execute activities of daily living using the Barthel Index (BI). [ Time Frame: 6 months ]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.
- Change from baseline in a subject's basic mobility and balance using the Timed Up and Go Test (TUG). [ Time Frame: 6 months ]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.
- Change from baseline in the function of subject's paretic limb using the Chedoke Arm and Hand Activity Inventory (CAHAI). [ Time Frame: 6 months ]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.
- Change from baseline in a subject's executive processing speed, language skills and memory using the Symbol Digit Modalities Test. [ Time Frame: 6 months ]Validated test assessing different aspects of cognitive function.
- Change from baseline in a subject's executive processing speed, language skills and memory using Controlled Oral Word Association tasks. [ Time Frame: 6 months ]Validated test assessing different aspects of cognitive function.
- Change from baseline in a subject's executive processing speed, language skills and memory using the Multilingual Naming Test. [ Time Frame: 6 months ]Validated test assessing different aspects of cognitive function.
- Change from baseline in a subject's executive processing speed, language skills and memory using the Montreal Cognitive Assessment. [ Time Frame: 6 months ]Validated test assessing different aspects of cognitive function.
- Change from baseline in a subject's neurological deficits using the National Institute of Health Stroke Scale (NIHSS). [ Time Frame: 6 months ]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.
- Change from baseline in restoring a subject's motor function using the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA). [ Time Frame: 6 months ]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.
- Change from baseline in subject's global rating of change regarding their limitations of activity, symptoms, and overall quality of life. [ Time Frame: 6 months ]Self-administered 2 factor questionnaire assessing change in limitations of activity, symptoms, and overall quality of life.
- Change from baseline in a subject's perception to stroke recovery using the Stroke Impact Scale (SIS). [ Time Frame: 6 months ]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.
- Change from baseline in a subject's health-related quality of life using the EQ-5D-5L. [ Time Frame: 6 months ]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.
- Safety: To assess the number and severity of adverse events and medical device incidents that occur over the study period. [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629275
|Contact: Vince Holmes||+44 (0) 203 819 firstname.lastname@example.org|
|Contact: Pre-screening center www.PISCES3.org|
|United States, California|
|University of California||Recruiting|
|Irvine, California, United States, 92697|
|Contact: Assessment and Surgical Center|
|Palo Alto, California, United States, 94304|
|Contact: Surgical Center|
|United States, Florida|
|University of South Florida||Recruiting|
|Tampa, Florida, United States, 33606|
|Contact: Assessment Center|
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|Contact: Assessment and Surgical Center|
|United States, Texas|
|University of Texas Health Science Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Assessment Center|
|Study Director:||Richard Beckman, MD||ReNeuron Ltd.|