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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 : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
ReNeuron Limited

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

Detailed Description:
This is a randomized, placebo-controlled, multi-center study. Patients with persistent disability 6-12 months following an ischemic stroke will be enrolled following confirmation of eligibility. Patients will be randomized 1:1 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
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 Surgery
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 :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Safety: To assess the number and severity of adverse events and medical device incidents that occur over the study period. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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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 12 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 four months prior to surgery)
  • 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


Contacts
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Contact: Vince Holmes +44 (0) 203 819 8400 info@reneuron.com
Contact: Pre-screening center www.PISCES3.org

Locations
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United States, California
University of California Recruiting
Irvine, California, United States, 92697
Contact: Assessment and Surgical Center         
University of California Recruiting
Los Angeles, California, United States, 90095
Contact: Assessment Center         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Assessment and Surgical Center         
University of California Recruiting
San Diego, California, United States, 92093-0706
Contact: Assessment Center         
United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Contact: Assessment and Surgical Center         
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Assessment Center         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Assessment and Surgical Center         
United States, Maryland
MedStar Health Research Institute Recruiting
Hyattsville, Maryland, United States, 20782
Contact: Assessment Center         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Surgical Center         
Principal Investigator: Julie Pilitsis         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Assessment and Surgical Center         
United States, Texas
University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Assessment Center and Surgical Center         
University of Texas Health Science Center Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Assessment Center         
Sponsors and Collaborators
ReNeuron Limited
Investigators
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Study Director: Richard Beckman, MD ReNeuron Ltd.

Additional Information:
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Responsible Party: ReNeuron Limited
ClinicalTrials.gov Identifier: NCT03629275     History of Changes
Other Study ID Numbers: RN01-CP-0003
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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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:
Efficacy
Neural Stem cells
Intracerebral
Cerebral Infarction
Cerebrovascular disorders
Brain diseases
Stereotactic surgery

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Paralysis
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Neurologic Manifestations
Signs and Symptoms