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History of Changes for Study: NCT03629275
Investigation of Neural Stem Cells in Ischemic Stroke (PISCES III)
Latest version (submitted October 17, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 10, 2018 None (earliest Version on record)
2 August 18, 2018 Contacts/Locations and Study Status
3 November 5, 2018 Recruitment Status, Contacts/Locations, Study Status and References
4 November 20, 2018 Contacts/Locations and Study Status
5 December 19, 2018 Contacts/Locations and Study Status
6 February 27, 2019 Contacts/Locations and Study Status
7 May 10, 2019 Contacts/Locations and Study Status
8 June 17, 2019 Contacts/Locations and Study Status
9 November 25, 2019 Study Status and Contacts/Locations
10 January 21, 2020 Study Status, Eligibility, Study Design and Study Description
11 February 25, 2020 Contacts/Locations and Study Status
12 June 17, 2020 Recruitment Status, Study Status and Contacts/Locations
13 August 5, 2020 Study Status and References
14 July 8, 2021 Recruitment Status, Study Status and Study Design
15 August 12, 2021 Study Status
16 October 17, 2022
Quality Control Review has not concluded Returned: November 9, 2022
Study Status, Outcome Measures, Document Section, Results and Study Design
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Study NCT03629275
Submitted Date:  August 10, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: RN01-CP-0003
Brief Title: Investigation of Neural Stem Cells in Ischemic Stroke (PISCES III)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2018
Overall Status: Not yet recruiting
Study Start: August 2018
Primary Completion: November 2019 [Anticipated]
Study Completion: May 2020 [Anticipated]
First Submitted: July 23, 2018
First Submitted that
Met QC Criteria:
August 10, 2018
First Posted: August 14, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
August 10, 2018
Last Update Posted: August 14, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ReNeuron Limited
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Ischemic Stroke
Chronic Stroke
Hemiparesis
Arm Paralysis
Keywords: Efficacy
Neural Stem cells
Intracerebral
Cerebral Infarction
Cerebrovascular disorders
Brain diseases
Stereotactic surgery
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 110 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 35 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Vince Holmes
Telephone: +44 (0) 203 819 8400
Email: vince-holmes@reneuron.com
Study Officials: Richard Beckman, MD
Study Director
ReNeuron Ltd.
Locations: United States, Massachusetts
ReNeuron
Burlington, Massachusetts, United States, 01944
Contact:Contact: Thomas Feinberg 781-270-1561 thomas-feinberg@reneuron.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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