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Trial record 3 of 3 for:    SB623

A Study of Modified Stem Cells in Traumatic Brain Injury (TBI) (STEMTRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02416492
Recruitment Status : Completed
First Posted : April 15, 2015
Results First Posted : December 27, 2021
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
SanBio, Inc.

Tracking Information
First Submitted Date  ICMJE April 6, 2015
First Posted Date  ICMJE April 15, 2015
Results First Submitted Date  ICMJE October 20, 2020
Results First Posted Date  ICMJE December 27, 2021
Last Update Posted Date December 27, 2021
Actual Study Start Date  ICMJE July 6, 2016
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2021)
Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients [ Time Frame: 24 weeks ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2015)
Change in Fugl-Meyer Motor Scale (FMMS) [ Time Frame: Change from baseline in Fugl-Meyer Motor Scale (FMMS) score at Month 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2021)
  • Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients [ Time Frame: 24 weeks ]
    DRS is an observer rated, 30-point ordinal scale that evaluates eight areas of functioning in four categories:
    1. Consciousness (eye opening, verbal response, motor response)
    2. Cognitive ability (feeding, toileting, grooming)
    3. Dependence on others
    4. Employability
    Each area of functioning was rated on a scale of 0 to either 3 or 5. The maximum score is 29 (extreme vegetative state) and the minimum score is 0 (person without disability).
  • Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients [ Time Frame: 24 weeks ]
    The ARAT total score is the sum of the scores from 19 tests spread across four subscales: grasp, grip, pinch, and gross movement. Each test is scored on an ordinal 4-point scale with 0= non movement, 1 = the movement task is partially performed, 2 = the movement task is completed but takes abnormally long, and 3 = the movement is performed normally. Summation of a 0-3 score in each item yields a total score between 0 and 57.
  • Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients [ Time Frame: 24 weeks ]
    Gait Velocity was measured on a standard 10 meter walk.
  • Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains [ Time Frame: 24 weeks ]
    Two NeuroQoL short form assessments were used (upper extremity function and lower extremity function); each has 8 items with 5 possible scores (e.g. 1= not at all, 2=a little bit, 3= somewhat, 4=quite a bit, 5=very much) or frequency ("never"to "always"); Raw scores are converted to T-scores based on a consistent metric (i.e., the T distribution) and data from the US general population. The theoretical range in scale for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively. When interpreting these T-scores, higher scores correspond to higher levels of functioning whereas lower scores correspond to lower levels of functioning.
  • Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician [ Time Frame: 24 weeks ]
    The proportions of SB623 treated subjects (pooling all SB623 doses) scoring either 7 (much better) or 6 (a little better, meaningful) on the Global Rating of Perceived Change (from Baseline) - Subject at Week 24 and on the Global Rating of Perceived Change (from Baseline) - Clinician at Week 24 was compared to the corresponding proportions of sham surgery control subjects using logistic regression models with adjustment for the baseline Fugl-Meyer Motor Scale score and the GOS-E score at screening as continuous covariates. 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2015)
  • Change in Disability Rating Scale (DRS) score [ Time Frame: Change from baseline in Disability Rating Scale (DRS) score at Month 6 ]
  • Change in Action Research Arm Test (ARAT) total score [ Time Frame: Change from baseline in Action Research Arm Test (ARAT) total score at Month 6 ]
  • Change in Gait Velocity [ Time Frame: Change from baseline in Gait Velocity at Month 6 ]
  • Change from baseline in T scores of NeuroQOL Domains -- Upper Extremity Function (Fine motor ADL) and Lower Extremity Function (Mobility) [ Time Frame: Change from baseline in T scores at Month 6 of NeuroQOL Domains -- Upper Extremity Function (Fine motor ADL) and Lower Extremity Function (Mobility) ]
  • Global Rating of Perceived Change scores [ Time Frame: Global Rating of Perceived Change scores at Month 6 from baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)
Official Title  ICMJE A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Traumatic Brain Injury (TBI)
Brief Summary The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of intracranial administration of SB623 cells on disability parameters and 2) to evaluate the safety and tolerability of intracranial administration of SB623 cells. Patients with stable, chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.
Detailed Description

This study was a multicenter, randomized (3:1) double-blind, active and sham-surgery controlled study to evaluate the safety, tolerability, and efficacy of stereotactic intracranial injection of SB623 cells in patients with fixed motor deficits from TBI. The study was conducted at approximately 22 sites across the United States, Ukraine, and Japan.

Two groups, Group 1 and Group 2, received investigational product SB623 and sham surgery, respectively, in a 3:1 randomization scheme. Group 1 was further randomized in a 1:1:1 ratio to receive either 2.5 million, 5 million, or 10 million SB623 cells. Randomization was performed via an interactive web response system (IWRS).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Biological: SB623 cells
    SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
  • Procedure: Sham Control
    Sham Surgery
Study Arms  ICMJE
  • Experimental: SB623 Cells
    SB623 Cells: 2.5, 5 or 10 million cells
    Intervention: Biological: SB623 cells
  • Sham Comparator: Sham Surgery
    Control Sham Surgery
    Intervention: Procedure: Sham Control
Publications * McCrea MA, Cramer SC, Okonkwo DO, Mattke S, Paadre S, Bates D, Nejadnik B, Giacino JT. Determining minimally clinically important differences for outcome measures in patients with chronic motor deficits secondary to traumatic brain injury. Expert Rev Neurother. 2021 Sep;21(9):1051-1058. doi: 10.1080/14737175.2021.1968299. Epub 2021 Aug 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2021)
63
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2015)
52
Actual Study Completion Date  ICMJE March 5, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented history of TBI, with correlated MRI or CT
  • At least 12 months post-TBI
  • Focal cerebral injury able to be identified on MRI (+/- concomitant diffuse axonal injury)
  • Neurological motor deficit substantially due to focal cerebral injury observed on MRI
  • GOS-E score of 3-6 (i.e. moderate or severe disability)
  • Require Motricity Index 10-81 (UE Scale) and/or 10-78 (LE Scale)
  • Able and willing to undergo computed tomography (CT) and magnetic resonance imaging (MRI)
  • Subjects must be willing to participate in study related exercises to the extent possible
  • Able to undergo all planned neurological assessments

Exclusion Criteria:

  • History or presence of any other major neurological disease
  • Any seizures in the prior 3 months
  • The presence of contracture at any joints that would interfere with interpretation of any of the neurological assessments (e.g. contracture preventing the detection of any increase in the range of motion or ability to perform a task)
  • Other neurologic, neuromuscular or orthopedic disease that limits motor function
  • Clincially significant finding on MRI of brain not related to TBI
  • Known presence of any malignancy except squamous or basal cell carcinoma of the skin
  • History of CNS malignancy
  • Positive findings on tests for occult malignancy, unless a non-malignant etiology is confirmed
  • Uncontrolled systemic illness, including, but not limited to: hypertension (systolic >150 mm Hg or diastolic >95 mm Hg); diabetes; renal, hepatic, or cardiac failure
  • Uncontrolled major psychiatric illness, including depression symptoms (CESD-R Scale of ≥16)
  • Unexplained abnormal preoperative test values (blood tests, electrocardiogram [ECG], chest X-ray); x-ray evidence of infection; uncontrolled atrial fibrillation or uncontrolled congestive heart failure
  • Presence of craniectomy (without bone flap replacement) or other contraindication to stereotactic surgery
  • Participation in any other investigational trial within 4 weeks of initial screening or within 7 weeks of study entry
  • Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) 16 weeks priot to the Baseline visit.
  • Ongoing use of other non-traditional drugs
  • Substance use disorder (per DSM-V criteria, including drug or alcohol)
  • Contraindications to head CT or MRI
  • Pregnant or lactating
  • Female patients of childbearing potential unwilling to use an adequate birth control method during the 12 months of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02416492
Other Study ID Numbers  ICMJE TBI-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SanBio, Inc.
Study Sponsor  ICMJE SanBio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel C Lu, MD, PhD University of California, Los Angeles, Department of Neurosurgery
PRS Account SanBio, Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP