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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by SanBio, Inc.
Information provided by (Responsible Party):
SanBio, Inc. Identifier:
First received: May 15, 2015
Last updated: September 13, 2017
Last verified: February 2017
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).


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02448641

Contact: Karen Minor (786) 888-1829

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham (Surgical/Assessment) Recruiting
Birmingham, Alabama, United States, 35233
Contact: Mark R Harrigan, MD         
United States, Arizona
Xenoscience, Inc. (Assessment) Recruiting
Phoenix, Arizona, United States, 85004
Contact: Stephen S Flitman, MD         
United States, California
The Research Center of Southern California (Assessment) Recruiting
Carlsbad, California, United States, 92011
Contact: Benjamin Frishberg, MD         
Neuro-Pain Medical Center (Assessment) Recruiting
Fresno, California, United States, 93710
Contact: Perminder Bhatia, MD         
Ronald Reagan UCLA Medical Center (Assessment/Surgical) Recruiting
Los Angeles, California, United States, 90095
Contact: Jason Hinman, MD, PhD         
University of California Irvine (Assessment) Recruiting
Orange, California, United States, 92868
Contact: Leonid Groysman, MD         
Westview Clinical Research (Assessment) Recruiting
Placentia, California, United States, 92870
Contact: Albert Lai, MD         
Providence Saint John's Health Center (Assessment) Recruiting
Santa Monica, California, United States, 90404
Contact: Santosh Kesari, MD, PhD         
Providence St. John's Health Center (Surgical) Recruiting
Santa Monica, California, United States, 90404
Contact: Achal S Achrol, MD         
Stanford Health Care (Surgical/Assessment) Recruiting
Stanford, California, United States, 94305
Contact: Gary K Steinberg, MD, PhD         
United States, Connecticut
New England Institute for Clinical Research (Assessment) Recruiting
Stamford, Connecticut, United States, 06905
Contact: Peter J McAllister, MD         
United States, District of Columbia
MedStar National Rehabilitation Hospital (Assessment) Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Richard Zorowitz, MD         
United States, Florida
University of Miami Miller School of Medicine (Assessment/Surgical) Recruiting
Miami, Florida, United States, 33136
Contact: Dileep R Yavagal, MD         
NeuroMedical Research Institute (Assessment) Recruiting
Panama City, Florida, United States, 32405
Contact: George Barrio, MD         
Medsol Clinical Research Center (Assessment) Recruiting
Port Charlotte, Florida, United States, 33952
Contact: George Li, MD         
Neurostudies, Inc. (Assessment) Recruiting
Port Charlotte, Florida, United States, 33952
Contact: Liliana Montoya, MD         
University of South Florida (Assessment) Recruiting
Tampa, Florida, United States, 33606
Contact: William S Burgin, MD         
United States, Georgia
Grady Memorial Hospital (Assessment) Recruiting
Atlanta, Georgia, United States, 30303
Contact: Samir Belagaje, MD         
Emory University Hospital (Surgical) Recruiting
Atlanta, Georgia, United States, 30322
Contact: Robert E Gross, MD, PhD         
United States, Illinois
University of Chicago Medical Center (Assessment) Recruiting
Chicago, Illinois, United States, 60637
Contact: James Brorson, MD         
University of Chicago Medical Center (Surgical) Recruiting
Chicago, Illinois, United States, 60637
Contact: Peter Warnke, MD         
Consultants in Neurology, Ltd. (Assessment) Recruiting
Northbrook, Illinois, United States, 60062
Contact: Daniel R Wynn, MD         
OSF Saint Francis Healthcare System (Assessment) Recruiting
Peoria, Illinois, United States, 61637
Contact: David Wang, DO         
United States, Indiana
Indiana Medical Research, Elkhart Clinic (Assessment) Recruiting
Elkhart, Indiana, United States, 46514
Contact: Thomas Vidic, MD         
United States, Kansas
University of Kansas Medical Center (Surgical) Recruiting
Kansas City, Kansas, United States, 66160
Contact: Paul J Camarata, MD         
Kansas Institute of Research (Assessment) Recruiting
Overland Park, Kansas, United States, 66211
Contact: Atul Patel, MD         
United States, Kentucky
University of Kentucky Hospital (Surgical) Recruiting
Lexington, Kentucky, United States, 40536
Contact: Craig van Horne, MD         
University of Louisville Clinical Trials Unit (Assessment) Recruiting
Louisville, Kentucky, United States, 40202
Contact: Wei Liu, MD, PhD         
United States, Louisiana
NeuroMedical Clinic of Central Louisiana (Assessment) Recruiting
Alexandria, Louisiana, United States, 71301
Contact: Gonzalo Hidalgo, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center (Surgical) Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ronnie L Alterman, MD         
United States, Michigan
Wayne State University (Assessment) Recruiting
Detroit, Michigan, United States, 48201
Contact: Kumar Rajamani, MD         
Henry Ford Health System (Assessment) Recruiting
Detroit, Michigan, United States, 48202
Contact: Angelos Katramados, MD         
United States, New Jersey
Rutgers New Jersey Medical School (Assessment) Not yet recruiting
Newark, New Jersey, United States, 07013
Contact: I. Paul Singh, MD         
United States, New York
New York University Langone Medical Center (Surgical/Assessment) Recruiting
New York, New York, United States, 10016
Contact: Douglas Kondziolka, MD         
The Burke Rehabilitation Hospital (Assessment) Recruiting
White Plains, New York, United States, 10605
Contact: Carolin Dohle, MD         
United States, North Carolina
Carolinas Rehabilitation (Assessment) Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Vu QC Nguyen, MD, MBA         
United States, Ohio
Neurology and Neuroscience Associates, Inc. (Assessment) Recruiting
Akron, Ohio, United States, 44320
Contact: DeRen Huang, MD, PhD         
University Hospital Case Medical Center (Surgical) Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jonathan Miller, MD         
University of Toledo Medical Center (Assessment) Recruiting
Toledo, Ohio, United States, 43614
Contact: Mouhammed Jumaa, MD         
United States, Pennsylvania
Moss Rehab (Assessment) Recruiting
Elkins Park, Pennsylvania, United States, 19006
Contact: Thomas Watanabe, MD         
Hospital of the University of Pennsylvania (Assessment) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Scott E Kasner, MD         
Pennsylvania Hospital (Surgical) Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Gordon H Baltuch, MD, PhD         
Thomas Jefferson University Comprehensive Stroke Center (Assessment) Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Rodney Bell, MD         
University of Pittsburgh Medical Center (Surgical/Assessment)) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lawrence Wechsler, MD         
Abington Neurological Associates (Assessment) Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Dan Gzesh, MD         
United States, South Carolina
Medical University of South Carolina (Surgical) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Istvan Takacs, MD         
United States, Tennessee
Chattanooga Center for Neurologic Research (Assessment) Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Thomas Devlin, MD, PhD         
United States, Texas
University of Texas Health Science Center at Houston (Assessment/Surgical) Recruiting
Houston, Texas, United States, 77030
Contact: Sean I Savitz, MD         
United States, West Virginia
West Virginia University Hospitals (Assessment) Recruiting
Morgantown, West Virginia, United States, 26506
Contact: John F Brick, MD         
Sponsors and Collaborators
SanBio, Inc.
Principal Investigator: Gary Steinberg, MD, PhD Stanford Hospital and Clinics, School of Medicine
  More Information

Responsible Party: SanBio, Inc. Identifier: NCT02448641     History of Changes
Other Study ID Numbers: SB-STR02
Study First Received: May 15, 2015
Last Updated: September 13, 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:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia processed this record on September 21, 2017