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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
Sham Surgery
Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients
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).
Time frame: 24 weeks
Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients
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).
Time frame: 24 weeks
Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients
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.
Time frame: 24 weeks
Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients
Gait Velocity was measured on a standard 10 meter walk.
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UCLA Medical Center (Surgical/Assessment)
Los Angeles, California, United States
Ronald Reagan UCLA Medical Denter
Los Angeles, California, United States
The Research Center of Southern California, LLC (Assessment)
Oceanside, California, United States
University of California, Irvine (Assessment/Surgical)
Orange, California, United States
Westview Clinical Research (Assessment)
Placentia, California, United States
Providence Saint John's Health Center
Santa Monica, California, United States
John Wayne Cancer Institute at Providence St. Johns Health Center
Santa Monica, California, United States
Stanford Health Care (Surgical/Assessment)
Stanford, California, United States
Craig Hospital
Englewood, Colorado, United States
Ki Health Partners, LLC dba New England Institute for Clinical Research (Assessment)
Stamford, Connecticut, United States
...and 26 more locations
Time frame: 24 weeks
Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains
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.
Time frame: 24 weeks
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
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
Time frame: 24 weeks