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

NCT02448641 | Completed Phase 2 Results DMC

• 1 other identifier: SB-STR02
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 65

Brief Summary

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

Conditions

Chronic Ischemic Stroke

Keywords

ischemic stroke; chronic stroke; fixed motor deficits

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Whose Fugl-Meyer Motor Total Score (FMMS) Improved by ≥ 10 Points at Month 6 From Baseline

  The FMMS is used as a clinical measure of body function impairment after stroke that assesses several dimensions of motor impairment, including range of motion in both upper and lower limbs, reflex activity, volitional movement, and co-ordination. The FMMS motor component consists of the 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items were then summed to determine scores for the 2 subscale scores, as well as a motor total score (total of all item scores including the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance). Responders: subjects whose FMMS motor total score improve by ≥10 points at Month 6 from Baseline

  6 months

Secondary Outcomes (5)

• Modified Rankin Scale Response: The Proportion of Subjects That Improved at Least One Point on the mRS From Baseline

  6 months

• The Proportion of Subjects That Improved at Least 6 Points From Baseline on the ARAT Total Score at the Affected Side

  6 months

• The Proportion of Subjects That Improved at Least 1 Functional Level From Baseline on Gait Velocity

  6 months

• Neurological Quality of Life Response: T-scores of the Change From Baseline in the 2 Sub-domains (Upper Extremity Function and Lower Extremity Function)

  6 Months

• Global Rating of Perceived Change (GRPC): The Proportion of Subjects Scoring Either 7 or 6 on the Global Rating of Perceived Change by Both Subject and Clinician

  6 Months (LOCF)

Other Outcomes (2)

• Additional Analysis (MMRM), Fugl-Meyer Motor Scale (FMMS)

  6 Months

• Proportion of Subjects Whose FMMS Motor Total Score Improve by ≥10 Points at Month 6 From Baseline (Per Protocol Population)

  Month 6

Study Arms (3)

SB623 Implant (2.5M)

EXPERIMENTAL

2.5 million SB623 cells

Biological: SB623 Implant (2.5M)

SB623 Implant (5.0M)

EXPERIMENTAL

5 million SB623 cells

Biological: SB623 Implant (5.0M)

Sham Control

SHAM COMPARATOR

Sham surgery

Procedure: Sham surgery

Interventions

SB623 Implant (2.5M) BIOLOGICAL

2.5 million SB623 cells

SB623 Implant (2.5M)

SB623 Implant (5.0M) BIOLOGICAL

5 million SB623 cells

SB623 Implant (5.0M)

Sham surgery PROCEDURE

Sham Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years, inclusive
• Documented history of completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI
• Between 6 and 90 months (7.5 years) post-stroke, and having a chronic motor neurological deficit
• Neurological motor deficit substantially due to incident stroke
• Modified Rankin Score of 2-4
• Require Motricity Index 30-75 (UE Scale) or 27-74 (LE Scale)
• Able to undergo all planned neurological assessments
• Able and willing to undergo magneti resonance imaging (MRI) with contrast and computed tomography (CT)
• 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
• Subjects must have had physical therapy prior to entry (and be willing to continue to the extent possible)
• 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
• Ability of patient or legal authorized representative to understand and sign an Informed Consent

You may not qualify if:

• History or presence of any other major neurological disease other than stroke
• Cerebral infarct size \>150 cm3 measured by MRI
• Primary intracerebral hemorrhage
• Myocardial infarction within prior 6 mos.
• Malignancy unless in remission \>5 yrs.
• Clinically significant finding on MRI of brain not related to stroke
• Any seizures in the 3 months prior to Screening
• More than 5 degrees of contracture at shoulder, elbow, wrist, fingers, hip, knee and ankle
• Other neurologic, neuromuscular or orthopedic disease that limits motor function
• Uncontrolled systemic illness, including, but not limited to: hypertension; diabetes; renal, hepatic, or cardiac failure
• Positive findings on tests for occult malignancy, unless a non-malignant etiology is confirmed
• Total bilirubin \>1.9 mg/dL at Screening
• Serum creatinine \>1.5 mg/dL at Screening
• Hemoglobin \<10.0 g/dL at Screening
• Absolute neutrophil count \<2000 /mm3 at Screening

Sponsors & Collaborators

• SanBio, Inc.: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (65)

University of Alabama at Birmingham (Surgical/Assessment)

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

Xenoscience, Inc. (Assessment)

Phoenix, Arizona, 85004, United States

Location

The Research Center of Southern California (Assessment)

Carlsbad, California, 92011, United States

Location

Rancho Los Amigos National Rehab Center

Downey, California, 90242, United States

Location

Neuro-Pain Medical Center (Assessment)

Fresno, California, 93710, United States

Location

Neuro Pain Medical Center

Fresno, California, 95710, United States

Location

University of California Irvine

Irvine, California, United States

Location

Ronald Reagan UCLA Medical Center (Assessment/Surgical)

Los Angeles, California, 90095, United States

Location

UCLA Medical Center

Los Angeles, California, United States

Location

University of California Irvine (Assessment)

Orange, California, 92868, United States

Location

Westview Clinical Research (Assessment)

Placentia, California, 92870, United States

Location

Providence Saint John's Health Center (Assessment)

Santa Monica, California, 90404, United States

Location

Providence St. John's Health Center (Surgical)

Santa Monica, California, 90404, United States

Location

Providence St. Johns Health Center

Santa Monica, California, United States

Location

Stanford Health Care (Surgical/Assessment)

Stanford, California, 94305, United States

Location

New England Institute for Clinical Research (Assessment)

Stamford, Connecticut, 06905, United States

Location

MedStar National Rehabilitation Hospital (Assessment)

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami Miller School of Medicine (Assessment/Surgical)

Miami, Florida, 33136, United States

Location

University of Miami Jackson Memorial Hospital

Miami, Florida, United States

Location

NeuroMedical Research Institute (Assessment)

Panama City, Florida, 32405, United States

Location

Medsol Clinical Research Center (Assessment)

Port Charlotte, Florida, 33952, United States

Location

Neurostudies, Inc. (Assessment)

Port Charlotte, Florida, 33952, United States

Location

University of South Florida (Assessment)

Tampa, Florida, 33606, United States

Location

Grady Memorial Hospital (Assessment)

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital (Surgical)

Atlanta, Georgia, 30322, United States

Location

Center for Advanced Research and Education (Assessment)

Gainesville, Georgia, 30501, United States

Location

Northwestern Memorial Hospital (Surgical)

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center (Assessment)

Chicago, Illinois, 60637, United States

Location

University of Chicago Medical Center (Surgical)

Chicago, Illinois, 60637, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Location

Consultants in Neurology, Ltd. (Assessment)

Northbrook, Illinois, 60062, United States

Location

OSF Saint Francis Healthcare System (Assessment)

Peoria, Illinois, 61637, United States

Location

Indiana Medical Research, Elkhart Clinic (Assessment)

Elkhart, Indiana, 46514, United States

Location

University of Kansas Medical Center (Surgical)

Kansas City, Kansas, 66160, United States

Location

Kansas Institute of Research (Assessment)

Overland Park, Kansas, 66211, United States

Location

University of Kentucky Hospital (Surgical)

Lexington, Kentucky, 40536, United States

Location

University of Louisville Clinical Trials Unit (Assessment)

Louisville, Kentucky, 40202, United States

Location

NeuroMedical Clinic of Central Louisiana (Assessment)

Alexandria, Louisiana, 71301, United States

Location

Beth Israel Deaconess Medical Center (Surgical)

Boston, Massachusetts, 02215, United States

Location

Wayne State University (Assessment)

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System (Assessment)

Detroit, Michigan, 48202, United States

Location

Henry Ford Hospital

Detroit, Michigan, United States

Location

Rutgers New Jersey Medical School (Assessment)

Newark, New Jersey, 07013, United States

Location

New York University Langone Medical Center (Surgical/Assessment)

New York, New York, 10016, United States

Location

NYU Langone Medical Center

New York, New York, United States

Location

The Burke Rehabilitation Hospital (Assessment)

White Plains, New York, 10605, United States

Location

Carolinas Rehabilitation (Assessment)

Charlotte, North Carolina, 28203, United States

Location

Neurology and Neuroscience Associates, Inc. (Assessment)

Akron, Ohio, 44320, United States

Location

Neurology and Neuroscience Associates

Akron, Ohio, 44320, United States

Location

University Hospital Case Medical Center (Surgical)

Cleveland, Ohio, 44106, United States

Location

University of Toledo Medical Center (Assessment)

Toledo, Ohio, 43614, United States

Location

Moss Rehab (Assessment)

Elkins Park, Pennsylvania, 19006, United States

Location

Hospital of the University of Pennsylvania (Assessment)

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital (Surgical)

Philadelphia, Pennsylvania, 19106, United States

Location

Thomas Jefferson University Comprehensive Stroke Center (Assessment)

Philadelphia, Pennsylvania, 19107, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh Medical Center (Surgical/Assessment))

Pittsburgh, Pennsylvania, 15213, United States

Location

Abington Neurological Associates (Assessment)

Willow Grove, Pennsylvania, 19090, United States

Location

Medical University of South Carolina (Surgical)

Charleston, South Carolina, 29425, United States

Location

Chattanooga Center for Neurologic Research (Assessment)

Chattanooga, Tennessee, 37403, United States

Location

University of Texas Medical School

Dallas, Texas, United States

Location

University of Texas Health Science Center at Houston (Assessment/Surgical)

Houston, Texas, 77030, United States

Location

West Virginia University Hospitals (Assessment)

Morgantown, West Virginia, 26506, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Bijan Nejadnik M.D.; Chief Medical Officer
• Organization: SanBio, Inc.

Bijan.Nejadnik@sanbio.com

650-625-2205

Study Officials

• Gary Steinberg, MD, PhD

  Stanford Hospital and Clinics, School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 19, 2015
• Study Start: March 8, 2016
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: October 8, 2020
• Results First Posted: April 17, 2020

Record last verified: 2020-04

Locations

US (65)