Trial record 1 of 6 for:
reneuron | stroke
Investigation of Neural Stem Cells in Ischemic Stroke (PISCES III)
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| ClinicalTrials.gov Identifier: NCT03629275 |
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Recruitment Status :
Terminated
(Strategic decision to progress stroke disability programme through regional partnerships)
First Posted : August 14, 2018
Last Update Posted : August 13, 2021
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Sponsor:
ReNeuron Limited
Information provided by (Responsible Party):
ReNeuron Limited
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Brief Summary:
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.
| 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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 15 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Primary Completion Date : | September 9, 2020 |
| Actual Study Completion Date : | March 2, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Ischemic Stroke
| Arm | Intervention/treatment |
|---|---|
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Experimental: CTX0E03 Drug Product and delivery device
20 million neural stem cells
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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. |
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Sham Comparator: Placebo
Sham Surgery
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Drug: 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. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 35 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
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
Locations
Show 23 study locations
Sponsors and Collaborators
ReNeuron Limited
Investigators
| Study Director: | Richard Beckman, MD | ReNeuron Ltd. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ReNeuron Limited |
| ClinicalTrials.gov Identifier: | NCT03629275 |
| Other Study ID Numbers: |
RN01-CP-0003 |
| First Posted: | August 14, 2018 Key Record Dates |
| Last Update Posted: | August 13, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Keywords provided by ReNeuron Limited:
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Efficacy Neural Stem cells Intracerebral Cerebral Infarction |
Cerebrovascular disorders Brain diseases Stereotactic surgery |
Additional relevant MeSH terms:
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Stroke Ischemic Stroke Cerebral Infarction Paralysis Paresis Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis Neurologic Manifestations |