Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
NCT ID: NCT02448641
Last Updated: 2020-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2016-03-08
2018-12-05
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SB623 Implant (2.5M)
2.5 million SB623 cells
SB623 Implant (2.5M)
2.5 million SB623 cells
SB623 Implant (5.0M)
5 million SB623 cells
SB623 Implant (5.0M)
5 million SB623 cells
Sham Control
Sham surgery
Sham surgery
Interventions
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SB623 Implant (2.5M)
2.5 million SB623 cells
SB623 Implant (5.0M)
5 million SB623 cells
Sham surgery
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
SanBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gary Steinberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford Hospital and Clinics, School of Medicine
Locations
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University of Alabama at Birmingham (Surgical/Assessment)
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Xenoscience, Inc. (Assessment)
Phoenix, Arizona, United States
The Research Center of Southern California (Assessment)
Carlsbad, California, United States
Rancho Los Amigos National Rehab Center
Downey, California, United States
Neuro-Pain Medical Center (Assessment)
Fresno, California, United States
Neuro Pain Medical Center
Fresno, California, United States
University of California Irvine
Irvine, California, United States
Ronald Reagan UCLA Medical Center (Assessment/Surgical)
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of California Irvine (Assessment)
Orange, California, United States
Westview Clinical Research (Assessment)
Placentia, California, United States
Providence Saint John's Health Center (Assessment)
Santa Monica, California, United States
Providence St. John's Health Center (Surgical)
Santa Monica, California, United States
Providence St. Johns Health Center
Santa Monica, California, United States
Stanford Health Care (Surgical/Assessment)
Stanford, California, United States
New England Institute for Clinical Research (Assessment)
Stamford, Connecticut, United States
MedStar National Rehabilitation Hospital (Assessment)
Washington D.C., District of Columbia, United States
University of Miami Miller School of Medicine (Assessment/Surgical)
Miami, Florida, United States
University of Miami Jackson Memorial Hospital
Miami, Florida, United States
NeuroMedical Research Institute (Assessment)
Panama City, Florida, United States
Medsol Clinical Research Center (Assessment)
Port Charlotte, Florida, United States
Neurostudies, Inc. (Assessment)
Port Charlotte, Florida, United States
University of South Florida (Assessment)
Tampa, Florida, United States
Grady Memorial Hospital (Assessment)
Atlanta, Georgia, United States
Emory University Hospital (Surgical)
Atlanta, Georgia, United States
Center for Advanced Research and Education (Assessment)
Gainesville, Georgia, United States
Northwestern Memorial Hospital (Surgical)
Chicago, Illinois, United States
University of Chicago Medical Center (Assessment)
Chicago, Illinois, United States
University of Chicago Medical Center (Surgical)
Chicago, Illinois, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Consultants in Neurology, Ltd. (Assessment)
Northbrook, Illinois, United States
OSF Saint Francis Healthcare System (Assessment)
Peoria, Illinois, United States
Indiana Medical Research, Elkhart Clinic (Assessment)
Elkhart, Indiana, United States
University of Kansas Medical Center (Surgical)
Kansas City, Kansas, United States
Kansas Institute of Research (Assessment)
Overland Park, Kansas, United States
University of Kentucky Hospital (Surgical)
Lexington, Kentucky, United States
University of Louisville Clinical Trials Unit (Assessment)
Louisville, Kentucky, United States
NeuroMedical Clinic of Central Louisiana (Assessment)
Alexandria, Louisiana, United States
Beth Israel Deaconess Medical Center (Surgical)
Boston, Massachusetts, United States
Wayne State University (Assessment)
Detroit, Michigan, United States
Henry Ford Health System (Assessment)
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Rutgers New Jersey Medical School (Assessment)
Newark, New Jersey, United States
New York University Langone Medical Center (Surgical/Assessment)
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
The Burke Rehabilitation Hospital (Assessment)
White Plains, New York, United States
Carolinas Rehabilitation (Assessment)
Charlotte, North Carolina, United States
Neurology and Neuroscience Associates, Inc. (Assessment)
Akron, Ohio, United States
Neurology and Neuroscience Associates
Akron, Ohio, United States
University Hospital Case Medical Center (Surgical)
Cleveland, Ohio, United States
University of Toledo Medical Center (Assessment)
Toledo, Ohio, United States
Moss Rehab (Assessment)
Elkins Park, Pennsylvania, United States
Hospital of the University of Pennsylvania (Assessment)
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital (Surgical)
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Comprehensive Stroke Center (Assessment)
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (Surgical/Assessment))
Pittsburgh, Pennsylvania, United States
Abington Neurological Associates (Assessment)
Willow Grove, Pennsylvania, United States
Medical University of South Carolina (Surgical)
Charleston, South Carolina, United States
Chattanooga Center for Neurologic Research (Assessment)
Chattanooga, Tennessee, United States
University of Texas Medical School
Dallas, Texas, United States
University of Texas Health Science Center at Houston (Assessment/Surgical)
Houston, Texas, United States
West Virginia University Hospitals (Assessment)
Morgantown, West Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SB-STR02
Identifier Type: -
Identifier Source: org_study_id
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