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Trial record 2 of 2 for:    sanbio AND stroke

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

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.
 
ClinicalTrials.gov Identifier: NCT02448641
Recruitment Status : Completed
First Posted : May 19, 2015
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
SanBio, Inc.

Tracking Information
First Submitted Date  ICMJE May 15, 2015
First Posted Date  ICMJE May 19, 2015
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE March 8, 2016
Actual Primary Completion Date December 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
Proportion of subjects whose Fugl-Meyer Motor scale (FMMS) improve by ≥10 points at Month 6 from Baseline [ Time Frame: Month 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02448641 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Official Title  ICMJE 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
Brief Summary Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Ischemic Stroke
Intervention  ICMJE
  • Biological: SB623 Implant (2.5M)
    2.5 million SB623 cells
  • Biological: SB623 Implant (5.0M)
    5 million SB623 cells
  • Procedure: Sham surgery
Study Arms  ICMJE
  • Experimental: SB623 Implant (2.5M)
    2.5 million SB623 cells
    Intervention: Biological: SB623 Implant (2.5M)
  • Experimental: SB623 Implant (5.0M)
    5 million SB623 cells
    Intervention: Biological: SB623 Implant (5.0M)
  • Sham Comparator: Sham Control
    Sham surgery
    Intervention: Procedure: Sham surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2019)
163
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2015)
156
Actual Study Completion Date  ICMJE December 5, 2018
Actual Primary Completion Date December 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02448641
Other Study ID Numbers  ICMJE SB-STR02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party SanBio, Inc.
Study Sponsor  ICMJE SanBio, Inc.
Collaborators  ICMJE Sunovion
Investigators  ICMJE
Principal Investigator: Gary Steinberg, MD, PhD Stanford Hospital and Clinics, School of Medicine
PRS Account SanBio, Inc.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP