search
Back to results

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

Primary Purpose

Chronic Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SB623 Implant (2.5M)
SB623 Implant (5.0M)
Sham surgery
Sponsored by
SanBio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ischemic Stroke focused on measuring ischemic stroke, chronic stroke, fixed motor deficits

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham (Surgical/Assessment)
  • University of Alabama at Birmingham
  • Xenoscience, Inc. (Assessment)
  • The Research Center of Southern California (Assessment)
  • Rancho Los Amigos National Rehab Center
  • Neuro-Pain Medical Center (Assessment)
  • Neuro Pain Medical Center
  • University of California Irvine
  • Ronald Reagan UCLA Medical Center (Assessment/Surgical)
  • UCLA Medical Center
  • University of California Irvine (Assessment)
  • Westview Clinical Research (Assessment)
  • Providence Saint John's Health Center (Assessment)
  • Providence St. John's Health Center (Surgical)
  • Providence St. Johns Health Center
  • Stanford Health Care (Surgical/Assessment)
  • New England Institute for Clinical Research (Assessment)
  • MedStar National Rehabilitation Hospital (Assessment)
  • University of Miami Miller School of Medicine (Assessment/Surgical)
  • University of Miami Jackson Memorial Hospital
  • NeuroMedical Research Institute (Assessment)
  • Medsol Clinical Research Center (Assessment)
  • Neurostudies, Inc. (Assessment)
  • University of South Florida (Assessment)
  • Grady Memorial Hospital (Assessment)
  • Emory University Hospital (Surgical)
  • Center for Advanced Research and Education (Assessment)
  • Northwestern Memorial Hospital (Surgical)
  • University of Chicago Medical Center (Assessment)
  • University of Chicago Medical Center (Surgical)
  • Rehabilitation Institute of Chicago
  • Consultants in Neurology, Ltd. (Assessment)
  • OSF Saint Francis Healthcare System (Assessment)
  • Indiana Medical Research, Elkhart Clinic (Assessment)
  • University of Kansas Medical Center (Surgical)
  • Kansas Institute of Research (Assessment)
  • University of Kentucky Hospital (Surgical)
  • University of Louisville Clinical Trials Unit (Assessment)
  • NeuroMedical Clinic of Central Louisiana (Assessment)
  • Beth Israel Deaconess Medical Center (Surgical)
  • Wayne State University (Assessment)
  • Henry Ford Health System (Assessment)
  • Henry Ford Hospital
  • Rutgers New Jersey Medical School (Assessment)
  • New York University Langone Medical Center (Surgical/Assessment)
  • NYU Langone Medical Center
  • The Burke Rehabilitation Hospital (Assessment)
  • Carolinas Rehabilitation (Assessment)
  • Neurology and Neuroscience Associates, Inc. (Assessment)
  • Neurology and Neuroscience Associates
  • University Hospital Case Medical Center (Surgical)
  • University of Toledo Medical Center (Assessment)
  • Moss Rehab (Assessment)
  • Hospital of the University of Pennsylvania (Assessment)
  • Pennsylvania Hospital (Surgical)
  • Thomas Jefferson University Comprehensive Stroke Center (Assessment)
  • Pennsylvania Hospital
  • University of Pittsburgh Medical Center (Surgical/Assessment))
  • Abington Neurological Associates (Assessment)
  • Medical University of South Carolina (Surgical)
  • Chattanooga Center for Neurologic Research (Assessment)
  • University of Texas Medical School
  • University of Texas Health Science Center at Houston (Assessment/Surgical)
  • West Virginia University Hospitals (Assessment)
  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

SB623 Implant (2.5M)

SB623 Implant (5.0M)

Sham Control

Arm Description

2.5 million SB623 cells

5 million SB623 cells

Sham surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
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.
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)

Full Information

First Posted
May 15, 2015
Last Updated
September 14, 2020
Sponsor
SanBio, Inc.
Collaborators
Sumitomo Pharma America, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02448641
Brief Title
Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Acronym
ACTIsSIMA
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
December 5, 2018 (Actual)
Study Completion Date
December 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SanBio, Inc.
Collaborators
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ischemic Stroke
Keywords
ischemic stroke, chronic stroke, fixed motor deficits

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SB623 Implant (2.5M)
Arm Type
Experimental
Arm Description
2.5 million SB623 cells
Arm Title
SB623 Implant (5.0M)
Arm Type
Experimental
Arm Description
5 million SB623 cells
Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Description
Sham surgery
Intervention Type
Biological
Intervention Name(s)
SB623 Implant (2.5M)
Intervention Description
2.5 million SB623 cells
Intervention Type
Biological
Intervention Name(s)
SB623 Implant (5.0M)
Intervention Description
5 million SB623 cells
Intervention Type
Procedure
Intervention Name(s)
Sham surgery
Primary Outcome Measure Information:
Title
Proportion of Subjects Whose Fugl-Meyer Motor Total Score (FMMS) Improved by ≥ 10 Points at Month 6 From Baseline
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Modified Rankin Scale Response: The Proportion of Subjects That Improved at Least One Point on the mRS From Baseline
Description
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.
Time Frame
6 months
Title
The Proportion of Subjects That Improved at Least 6 Points From Baseline on the ARAT Total Score at the Affected Side
Description
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.
Time Frame
6 months
Title
The Proportion of Subjects That Improved at Least 1 Functional Level From Baseline on Gait Velocity
Description
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
Time Frame
6 months
Title
Neurological Quality of Life Response: T-scores of the Change From Baseline in the 2 Sub-domains (Upper Extremity Function and Lower Extremity Function)
Description
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.
Time Frame
6 Months
Title
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
Description
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)
Time Frame
6 Months (LOCF)
Other Pre-specified Outcome Measures:
Title
Additional Analysis (MMRM), Fugl-Meyer Motor Scale (FMMS)
Description
An additional analysis using mixed model for repeated measures (MMRM) was performed treating the change from Baseline in FMMS total score as a continuous outcome (dependent) variable. The independent variables were treatment, visit, treatment-by-visit interaction, and pooled surgical site as effects, and Baseline FMMS total score and Baseline mRS score as covariates. Least-squares means (LS-mean) with SE was calculated for the change from baseline measurements.
Time Frame
6 Months
Title
Proportion of Subjects Whose FMMS Motor Total Score Improve by ≥10 Points at Month 6 From Baseline (Per Protocol Population)
Description
Responders: subjects whose FMMS motor total score improve by ≥10 points at Month 6 from Baseline
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Steinberg, MD, PhD
Organizational Affiliation
Stanford Hospital and Clinics, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham (Surgical/Assessment)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Xenoscience, Inc. (Assessment)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
The Research Center of Southern California (Assessment)
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Rancho Los Amigos National Rehab Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Neuro-Pain Medical Center (Assessment)
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Neuro Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
95710
Country
United States
Facility Name
University of California Irvine
City
Irvine
State/Province
California
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center (Assessment/Surgical)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of California Irvine (Assessment)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Westview Clinical Research (Assessment)
City
Placentia
State/Province
California
ZIP/Postal Code
92870
Country
United States
Facility Name
Providence Saint John's Health Center (Assessment)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Providence St. John's Health Center (Surgical)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Providence St. Johns Health Center
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Stanford Health Care (Surgical/Assessment)
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
New England Institute for Clinical Research (Assessment)
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
MedStar National Rehabilitation Hospital (Assessment)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Miami Miller School of Medicine (Assessment/Surgical)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Jackson Memorial Hospital
City
Miami
State/Province
Florida
Country
United States
Facility Name
NeuroMedical Research Institute (Assessment)
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Medsol Clinical Research Center (Assessment)
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Neurostudies, Inc. (Assessment)
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
University of South Florida (Assessment)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Grady Memorial Hospital (Assessment)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital (Surgical)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Center for Advanced Research and Education (Assessment)
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northwestern Memorial Hospital (Surgical)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medical Center (Assessment)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center (Surgical)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Consultants in Neurology, Ltd. (Assessment)
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
OSF Saint Francis Healthcare System (Assessment)
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Indiana Medical Research, Elkhart Clinic (Assessment)
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
University of Kansas Medical Center (Surgical)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kansas Institute of Research (Assessment)
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
University of Kentucky Hospital (Surgical)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville Clinical Trials Unit (Assessment)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
NeuroMedical Clinic of Central Louisiana (Assessment)
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Surgical)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wayne State University (Assessment)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System (Assessment)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Rutgers New Jersey Medical School (Assessment)
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Facility Name
New York University Langone Medical Center (Surgical/Assessment)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
The Burke Rehabilitation Hospital (Assessment)
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Carolinas Rehabilitation (Assessment)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Neurology and Neuroscience Associates, Inc. (Assessment)
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Neurology and Neuroscience Associates
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
University Hospital Case Medical Center (Surgical)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Toledo Medical Center (Assessment)
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Moss Rehab (Assessment)
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19006
Country
United States
Facility Name
Hospital of the University of Pennsylvania (Assessment)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital (Surgical)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Thomas Jefferson University Comprehensive Stroke Center (Assessment)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Medical Center (Surgical/Assessment))
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Abington Neurological Associates (Assessment)
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Medical University of South Carolina (Surgical)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Chattanooga Center for Neurologic Research (Assessment)
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
University of Texas Medical School
City
Dallas
State/Province
Texas
Country
United States
Facility Name
University of Texas Health Science Center at Houston (Assessment/Surgical)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
West Virginia University Hospitals (Assessment)
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs