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
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Biological: SB623 cells Procedure: Sham Control||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||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)|
|Actual Study Start Date :||July 6, 2016|
|Actual Primary Completion Date :||January 31, 2019|
|Actual Study Completion Date :||March 5, 2019|
Experimental: SB623 Cells
SB623 Cells: 2.5, 5 or 10 million cells
Biological: SB623 cells
SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
Sham Comparator: Sham Surgery
Control Sham Surgery
Procedure: Sham Control
- 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).
- 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:
- Consciousness (eye opening, verbal response, motor response)
- Cognitive ability (feeding, toileting, grooming)
- Dependence on others
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416492
|Principal Investigator:||Daniel C Lu, MD, PhD||University of California, Los Angeles, Department of Neurosurgery|