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Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (ACTIsSIMA)

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ClinicalTrials.gov Identifier: NCT02448641
Recruitment Status : Completed
First Posted : May 19, 2015
Results First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
SanBio, Inc.

Brief Summary:
Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke

Condition or disease Intervention/treatment Phase
Chronic Ischemic Stroke Biological: SB623 Implant (2.5M) Biological: SB623 Implant (5.0M) Procedure: Sham surgery Phase 2

Detailed Description:

This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke. The study will be conducted at approximately 65 sites in the United States.

Two cohorts, Group 1 (2.5 and 5 million SB623 cells combined) and Group 2 (sham placebo), will be included in this study. Subjects who are randomized into this study will receive either 2.5 million SB623 cells, 5 million SB623 cells or sham surgery at a 1:1:1 randomization ratio. Randomization will be performed via an interactive web/voice response system (IXRS), stratified by Screening mRS score (recorded in the IXRS at the clinical site).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Controlled Phase 2b Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : December 5, 2018

Arm Intervention/treatment
Experimental: SB623 Implant (2.5M)
2.5 million SB623 cells
Biological: SB623 Implant (2.5M)
2.5 million SB623 cells

Experimental: SB623 Implant (5.0M)
5 million SB623 cells
Biological: SB623 Implant (5.0M)
5 million SB623 cells

Sham Comparator: Sham Control
Sham surgery
Procedure: Sham surgery



Primary Outcome Measures :
  1. Fugl-Meyer Motor Scale Total Score Response; Modified Intent to Treat Population [ Time Frame: 6 months ]
    Fugl-Meyer Motor Scale (FMMS) Motor Total Score: The FMMS is used as a clinical measure of body function impairment after stroke that assessed several dimensions of motor impairment, including range of motion in both upper and lower limbs, including reflex activity, volitional movement, and co-ordination. The upper extremity subscale (33 items) and lower extremity subscale (17 items) were assessed for determination of efficacy. The FMMS is an ordinal scale that has 3 points for each item. The upper limb is scored between 0 and 66 points and the lower limb is scored between 0 and 34 points. The FMMS motor total score range from 0 (hemiplegia) to a maximum of 100 points (normal motor performance).

  2. Fugl-Meyer Motor Scale Total Score Response; Per Protocol Population [ Time Frame: Month 6 ]
    Fugl-Meyer Motor Scale (FMMS) Motor Total Score: The FMMS is used as a clinical measure of body function impairment after stroke that assessed several dimensions of motor impairment, including range of motion in both upper and lower limbs, including reflex activity, volitional movement, and co-ordination. The upper extremity subscale (33 items) and lower extremity subscale (17 items) were assessed for determination of efficacy. The FMMS is an ordinal scale that has 3 points for each item. The upper limb is scored between 0 and 66 points and the lower limb is scored between 0 and 34 points. The FMMS motor total score range from 0 (hemiplegia) to a maximum of 100 points (normal motor performance).

  3. Additional Analysis, Fugl-Meyer Motor Scale (FMMS) [ Time Frame: Month 6 ]
    FMMS motor total score is summation of all 50 item scores with maximum of 100 points. The item scores are on 0 to 2 scale (0 = cannot perform, 1 = partial motion, 2 = full motion)


Secondary Outcome Measures :
  1. Modified Rankin Scale Response, Modified Intent to Treat Population [ Time Frame: Month 6 ]
    Modified Rankin Scale (mRS): This scale is used to measure the degree of disability or dependence in the daily activities of people who had suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death.

  2. Action Research Arm Test Response, Modified Intent to Treat Population [ Time Frame: Month 6 ]
    Action Research Arm Test (ARAT): The test was scored for left and right side separately. Performance on each item was rated on a 4-point ordinal scale ranging from: 3 (performed test normally in less than 5 seconds); 2 (completed test, but took abnormally long or had great difficult, with time varying from 5 to 60 seconds; 1 (performed test partially); 0 (could perform no part of the test). The ARAT is a 19-item measure divided into 4 subtests: Grasp subscale (with 6 items and a score range of 0 to 18); Grip subscale with 4 items and a score range of 0 to 12); Pinch subscale with 6 items and a score range of 0 to 18); Gross arm movement subscale (with 3 items and a score range of 0 to 9). The maximum score on the ARAT is 57 points (possible range 0 to 57) for each side.

  3. Gait Velocity Response Rate; Modified Intent to Treat Population [ Time Frame: Month 6 ]
    Gait Velocity was measured on a standard 10 meter walk. Two trials were tested and the average result from the two trails was used for analysis

  4. Neurological Quality of Life Response [ Time Frame: baseline, Month 6 ]
    The Neurological Quality of Life (NeuroQOL) was used as a measure of change in the levels of Quality of Life, Satisfaction and Participation, secondary to improvements in the subject's upper and lower extremity motor function. NeuroQOL is summation of item scores for upper extremity (8 terms: score 8 - 40) and lower extremity (8 items: score 8 - 40) separately. The item scores are on a 1 to 5 scale (1 = unable to do; 2 = with much difficulty; 3 = with some difficulty; 4 = with little difficulty; 5 = without any difficulty). The result provided here shows NeuroQOL score converted to T-score as per conversion tables provided in Statistical Analysis Plan (SAP)-document Page no. 41 and 42. Referring to that, the range for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively. For any other information associated with NeuroQOL calculation, please refer SAP document dated December 21, 2018 provided under document section of this study.

  5. Global Rating of Perceived Change Response Rate [ Time Frame: 6 Months ]
    Global Rating of Perceived Change from Baseline: Subjects and Clinicians were asked about perceived changes in their motor function by comparing "how well they are doing compared to before the surgical procedure". The Subject Global Rating of Perceived Change was completed by the subject (or by the caregiver using the subject's answers). The following 7-point Likert scale was used: Score 7 (much better); Score 6 (a little better, meaningful); Score 5 (a little better, not meaningful); Score 4 (about the same); Score 3 (a little worse, not meaningful); Score 2 (a little worse, meaningful); Score 1 (much worse)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75 years, inclusive
  2. Documented history of completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI
  3. Between 6 and 90 months (7.5 years) post-stroke, and having a chronic motor neurological deficit
  4. Neurological motor deficit substantially due to incident stroke
  5. Modified Rankin Score of 2-4
  6. Require Motricity Index 30-75 (UE Scale) or 27-74 (LE Scale)
  7. Able to undergo all planned neurological assessments
  8. Able and willing to undergo magneti resonance imaging (MRI) with contrast and computed tomography (CT)
  9. Agree that use of antiplatelet, anti-coagulant, or non-steroidal anti-inflammatory drugs to be determined by the local medical staff and in accordance with the ACCP 2012 guideline "Perioperative Management of Antithrombotic Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th Edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines", if applicable , provided that no antiplatelet, anti-coagulant, or non-steroidal anti-inflammatory drugs are to be restarted post-surgery until after the Day 8 MRI is read and are determined to be safe to re-start
  10. Subjects must have had physical therapy prior to entry (and be willing to continue to the extent possible)
  11. Must be willing to discontinue herbal or non-traditional medicines for 1 week before and 1 week after the surgical procedure and be willing to continue to the extent possible
  12. Ability of patient or legal authorized representative to understand and sign an Informed Consent

Exclusion Criteria:

  1. History or presence of any other major neurological disease other than stroke
  2. Cerebral infarct size >150 cm3 measured by MRI
  3. Primary intracerebral hemorrhage
  4. Myocardial infarction within prior 6 mos.
  5. Malignancy unless in remission >5 yrs.
  6. Clinically significant finding on MRI of brain not related to stroke
  7. Any seizures in the 3 months prior to Screening
  8. More than 5 degrees of contracture at shoulder, elbow, wrist, fingers, hip, knee and ankle
  9. Other neurologic, neuromuscular or orthopedic disease that limits motor function
  10. Uncontrolled systemic illness, including, but not limited to: hypertension; diabetes; renal, hepatic, or cardiac failure
  11. Positive findings on tests for occult malignancy, unless a non-malignant etiology is confirmed
  12. Uncontrolled major psychiatric illness, including depression symptoms (CESD R Scale of ≥16 is exclusionary)
  13. Total bilirubin >1.9 mg/dL at Screening
  14. Serum creatinine >1.5 mg/dL at Screening
  15. Hemoglobin <10.0 g/dL at Screening
  16. Absolute neutrophil count <2000 /mm3 at Screening
  17. Absolute lymphocytes <800 /mm3 at Screening
  18. Platelet count <100,000 /mm3 at Screening
  19. Liver disease supported by AST (SGOT) or ALT (SGPT) ≥2.5 x upper limit of normal at Screening
  20. Serum calcium >11.5 mg/dL at Screening
  21. International Normalized Ratio of Prothrombin Time (INR) >1.2 at Screening if the patient does not take anticoagulants; for patients on anticoagulants, INR must be confirmed to be ≤1.2 prior to surgery
  22. Presence of craniectomy or other contraindication to stereotactic surgery
  23. Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of Baseline visit
  24. Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) 16 weeks prior to the Baseline visit
  25. Substance use disorder (per DSM-V criteria, including drug or alcohol)
  26. Contraindications to head MRI (with constrast) or CT
  27. Pregnant or lactating
  28. Female patients of childbearing potential unwilling to use an adequate birth control method during the 12 months of the study
  29. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study
  30. Any prior SB623 cell implantation and/or any prior stem cell treatment for stroke or other reason regardless of mode of administration

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): NCT02448641


Locations
Show Show 65 study locations
Sponsors and Collaborators
SanBio, Inc.
Sunovion
Investigators
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Principal Investigator: Gary Steinberg, MD, PhD Stanford Hospital and Clinics, School of Medicine
  Study Documents (Full-Text)

Documents provided by SanBio, Inc.:
Study Protocol  [PDF] January 5, 2017
Statistical Analysis Plan  [PDF] December 21, 2018


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Responsible Party: SanBio, Inc.
ClinicalTrials.gov Identifier: NCT02448641    
Other Study ID Numbers: SB-STR02
First Posted: May 19, 2015    Key Record Dates
Results First Posted: April 17, 2020
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by SanBio, Inc.:
ischemic stroke
chronic stroke
fixed motor deficits
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia