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Chronic Ischemic StrokePhase 2ACTIsSIMANCT02448641

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

A Phase 2 study testing SB623 Implant (2.5M) and SB623 Implant (5.0M) in people with Chronic Ischemic Stroke, run by SanBio, Inc. at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Ischemic Stroke
What is being tested?
SB623 Implant (2.5M) and SB623 Implant (5.0M)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
65 sitesUnited States
Study dates
8 Mar 2016to 5 Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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
  • Uncontrolled major psychiatric illness, including depression symptoms (CESD R Scale of ≥16 is exclusionary)
  • 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
  • Absolute lymphocytes <800 /mm3 at Screening
  • Platelet count <100,000 /mm3 at Screening
  • Liver disease supported by AST (SGOT) or ALT (SGPT) ≥2.5 x upper limit of normal at Screening
  • Serum calcium >11.5 mg/dL at Screening
  • 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
  • Presence of craniectomy or other contraindication to stereotactic surgery
  • Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of Baseline visit
  • 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
  • Substance use disorder (per DSM-V criteria, including drug or alcohol)
  • Contraindications to head MRI (with constrast) or CT
  • Pregnant or lactating
  • Female patients of childbearing potential unwilling to use an adequate birth control method during the 12 months of the study
  • 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
  • Any prior SB623 cell implantation and/or any prior stem cell treatment for stroke or other reason regardless of mode of administration

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Neurology and Neuroscience Associates, Inc. (Assessment)

    Akron, Ohio, 44320

  • Neurology and Neuroscience Associates

    Akron, Ohio, 44320

  • NeuroMedical Clinic of Central Louisiana (Assessment)

    Alexandria, Louisiana, 71301

  • Grady Memorial Hospital (Assessment)

    Atlanta, Georgia, 30303

  • Emory University Hospital (Surgical)

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham (Surgical/Assessment)

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama

  • Beth Israel Deaconess Medical Center (Surgical)

    Boston, Massachusetts, 02215

  • The Research Center of Southern California (Assessment)

    Carlsbad, California, 92011

  • Medical University of South Carolina (Surgical)

    Charleston, South Carolina, 29425

  • Carolinas Rehabilitation (Assessment)

    Charlotte, North Carolina, 28203

  • Chattanooga Center for Neurologic Research (Assessment)

    Chattanooga, Tennessee, 37403

  • Northwestern Memorial Hospital (Surgical)

    Chicago, Illinois, 60611

  • University of Chicago Medical Center (Assessment)

    Chicago, Illinois, 60637

  • University of Chicago Medical Center (Surgical)

    Chicago, Illinois, 60637

  • Rehabilitation Institute of Chicago

    Chicago, Illinois

  • University Hospital Case Medical Center (Surgical)

    Cleveland, Ohio, 44106

  • University of Texas Medical School

    Dallas, Texas

  • Wayne State University (Assessment)

    Detroit, Michigan, 48201

  • Henry Ford Health System (Assessment)

    Detroit, Michigan, 48202

  • Henry Ford Hospital

    Detroit, Michigan

  • Rancho Los Amigos National Rehab Center

    Downey, California, 90242

  • Indiana Medical Research, Elkhart Clinic (Assessment)

    Elkhart, Indiana, 46514

  • Moss Rehab (Assessment)

    Elkins Park, Pennsylvania, 19006

  • Neuro-Pain Medical Center (Assessment)

    Fresno, California, 93710

  • Neuro Pain Medical Center

    Fresno, California, 95710

  • Center for Advanced Research and Education (Assessment)

    Gainesville, Georgia, 30501

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

    Houston, Texas, 77030

  • University of California Irvine

    Irvine, California

  • University of Kansas Medical Center (Surgical)

    Kansas City, Kansas, 66160

  • University of Kentucky Hospital (Surgical)

    Lexington, Kentucky, 40536

  • Ronald Reagan UCLA Medical Center (Assessment/Surgical)

    Los Angeles, California, 90095

  • UCLA Medical Center

    Los Angeles, California

  • University of Louisville Clinical Trials Unit (Assessment)

    Louisville, Kentucky, 40202

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

    Miami, Florida, 33136

  • University of Miami Jackson Memorial Hospital

    Miami, Florida

  • West Virginia University Hospitals (Assessment)

    Morgantown, West Virginia, 26506

  • West Virginia University

    Morgantown, West Virginia, 26506

  • New York University Langone Medical Center (Surgical/Assessment)

    New York, New York, 10016

  • NYU Langone Medical Center

    New York, New York

  • Rutgers New Jersey Medical School (Assessment)

    Newark, New Jersey, 07013

  • Consultants in Neurology, Ltd. (Assessment)

    Northbrook, Illinois, 60062

  • University of California Irvine (Assessment)

    Orange, California, 92868

  • Kansas Institute of Research (Assessment)

    Overland Park, Kansas, 66211

  • NeuroMedical Research Institute (Assessment)

    Panama City, Florida, 32405

  • OSF Saint Francis Healthcare System (Assessment)

    Peoria, Illinois, 61637

  • Hospital of the University of Pennsylvania (Assessment)

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital (Surgical)

    Philadelphia, Pennsylvania, 19106

  • Thomas Jefferson University Comprehensive Stroke Center (Assessment)

    Philadelphia, Pennsylvania, 19107

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania

  • Xenoscience, Inc. (Assessment)

    Phoenix, Arizona, 85004

  • University of Pittsburgh Medical Center (Surgical/Assessment))

    Pittsburgh, Pennsylvania, 15213

  • Westview Clinical Research (Assessment)

    Placentia, California, 92870

  • Medsol Clinical Research Center (Assessment)

    Port Charlotte, Florida, 33952

  • Neurostudies, Inc. (Assessment)

    Port Charlotte, Florida, 33952

  • Providence Saint John's Health Center (Assessment)

    Santa Monica, California, 90404

  • Providence St. John's Health Center (Surgical)

    Santa Monica, California, 90404

  • Providence St. Johns Health Center

    Santa Monica, California

  • New England Institute for Clinical Research (Assessment)

    Stamford, Connecticut, 06905

  • Stanford Health Care (Surgical/Assessment)

    Stanford, California, 94305

  • University of South Florida (Assessment)

    Tampa, Florida, 33606

  • University of Toledo Medical Center (Assessment)

    Toledo, Ohio, 43614

  • MedStar National Rehabilitation Hospital (Assessment)

    Washington D.C., District of Columbia, 20010

  • The Burke Rehabilitation Hospital (Assessment)

    White Plains, New York, 10605

  • Abington Neurological Associates (Assessment)

    Willow Grove, Pennsylvania, 19090

Other trials in United States

About this study

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

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

Read the 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).

Being tested
SB623 Implant (2.5M), SB623 Implant (5.0M), Sham surgery
Keywords
ischemic stroke, chronic stroke, fixed motor deficits
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB623 Implant (2.5M)Biological

    2.5 million SB623 cells

  • SB623 Implant (5.0M)Biological

    5 million SB623 cells

  • Sham surgeryProcedure or surgery

Study groups in NCT02448641
Study groupRoleWhat they receive
SB623 Implant (2.5M)Experimental2.5 million SB623 cells
Receives: Biological: SB623 Implant (2.5M)
SB623 Implant (5.0M)Experimental5 million SB623 cells
Receives: Biological: SB623 Implant (5.0M)
Sham ControlSham comparatorSham surgery
Receives: Procedure: Sham surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (5)

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

    Responders: The subjects that improved at least one point on the mRS from Baseline

    Modified Rankin Scale (mRS): This scale is used to measure the degree of disability or dependence in the daily activities of people who had suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death.

    Measured: 6 months

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

    Responders: The subjects that improved at least 6 points from Baseline on the ARAT total score at the affected side.

    Action Research Arm Test (ARAT): The test was scored for left and right side separately. Performance on each item was rated on a 4-point ordinal scale ranging from: 3 (performed test normally in less than 5 seconds); 2 (completed test, but took abnormally long or had great difficult, with time varying from 5 to 60 seconds; 1 (performed test partially); 0 (could perform no part of the test). The ARAT is a 19-item measure divided into 4 subtests: Grasp subscale (with 6 items and a score range of 0 to 18); Grip subscale with 4 items and a score range of 0 to 12); Pinch subscale with 6 items and a score range of 0 to 18); Gross arm movement subscale (with 3 items and a score range of 0 to 9). The maximum score on the ARAT is 57 points (possible range 0 to 57) for each side.

    Measured: 6 months

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

    Responders: The subjects that improved at least 1 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) from Baseline on Gait Velocity.

    Gait Velocity was measured on a standard 10 meter walk. Two trials were tested and the average result from both was used for analysis

    Measured: 6 months

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

    The Neurological Quality of Life (NeuroQOL) was used as a measure of change in the levels of Quality of Life, Satisfaction and Participation, secondary to improvements in the subject's upper and lower extremity motor function. NeuroQOL is summation of item scores for upper extremity (8 terms: score 8 - 40) and lower extremity (8 items: score 8 - 40) separately. The item scores are on a 1 to 5 scale (1 = unable to do; 2 = with much difficulty; 3 = with some difficulty; 4 = with little difficulty; 5 = without any difficulty). The result provided here shows NeuroQOL score converted to T-score. The range for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively.

    Measured: 6 Months

  5. 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

    Responders: Participants who scored either 7 [much better] or 6 [a little better, meaningful])

    Global Rating of Perceived Change from Baseline: Subjects and Clinicians were asked about perceived changes in their motor function by comparing "how well they are doing compared to before the surgical procedure". The Subject Global Rating of Perceived Change was completed by the subject (or by the caregiver using the subject's answers). The following 7-point Likert scale was used: Score 7 (much better); Score 6 (a little better, meaningful); Score 5 (a little better, not meaningful); Score 4 (about the same); Score 3 (a little worse, not meaningful); Score 2 (a little worse, meaningful); Score 1 (much worse)

    Measured: 6 Months (LOCF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2015 (estimated)
  2. Study start8 Mar 2016
  3. Primary completion5 Dec 2018
  4. Study completion5 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02448641
Sponsor's protocol ID
SB-STR02
Acronym
ACTIsSIMA
Status last verified
Apr 2020
First submitted
15 May 2015
Last updated
8 Oct 2020
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SB623 Implant (2.5M) and SB623 Implant (5.0M) in people with Chronic Ischemic Stroke, run by SanBio, Inc. at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects Whose Fugl-Meyer Motor Total Score (FMMS) Improved by ≥ 10 Points at Month 6 From Baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02448641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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