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Trial record 1 of 3 for:    sanbio | ischemic stroke
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Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (ACTIsSIMA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02448641
First Posted: May 19, 2015
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sunovion
Information provided by (Responsible Party):
SanBio, Inc.
  Purpose
Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke

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

Study Type: Interventional
Study Design: 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

Further study details as provided by SanBio, Inc.:

Primary Outcome Measures:
  • Proportion of subjects whose Fugl-Meyer Motor scale (FMMS) improve by ≥10 points at Month 6 from Baseline [ Time Frame: Month 6 ]

Secondary Outcome Measures:
  • Proportion of subjects whose Modified Rankin Scale (mRS) improve by ≥1 point at Month 6 from Baseline [ Time Frame: Month 6 ]
  • Proportion of subjects whose Action Research Arm Test (ARAT) improve by ≥6 points [ Time Frame: Month 6 ]
  • Proportion of subjects whose Gait Velocity on standard 10 m walk improve at least one functional level [eg, from < 0.4 m/s to 0.4-0.8 m/s or from 0.4 0.8 m/s to >0.8 m/s]) at Month 6 from Baseline [ Time Frame: Month 6 ]
  • Mean change in T scores at Month 6 of NeuroQOL sub-domains Upper Extremity Function (Fine motor ADL) Lower Extremity Function (Mobility) [ Time Frame: Month 6 ]
  • Proportion of subjects scoring 7 (much better) or 6 (a little improved) in the Global Rating of Perceived Change scores at Month 6 assessed by subject (may be completed by caregiver) and by clinician [ Time Frame: Month 6 ]
  • All adverse events whether or not related to SB623 or surgical procedure using WHO toxicity criteria [ Time Frame: Month 12 ]
  • Adverse changes imaged by head MRI [ Time Frame: Month 12 ]
  • Serious adverse events (SAEs) using WHO toxicity criteria [ Time Frame: Month 12 ]
  • Serum chemistry hematology, vital signs, physical examinations [ Time Frame: Month 12 ]
  • Changes in serum antibodies to SB623 over time [ Time Frame: Month 12 ]

Estimated Enrollment: 156
Study Start Date: January 2016
Estimated Study Completion Date: September 30, 2019
Estimated Primary Completion Date: May 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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


  Show 51 Study Locations
Sponsors and Collaborators
SanBio, Inc.
Sunovion
Investigators
Principal Investigator: Gary Steinberg, MD, PhD Stanford Hospital and Clinics, School of Medicine
  More Information

Responsible Party: SanBio, Inc.
ClinicalTrials.gov Identifier: NCT02448641     History of Changes
Other Study ID Numbers: SB-STR02
First Submitted: May 15, 2015
First Posted: May 19, 2015
Last Update Posted: November 7, 2017
Last Verified: October 2017
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:
Stroke
Ischemia
Brain Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction