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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB623 Cells | Experimental | SB623 Cells: 2.5, 5 or 10 million cells |
|
| Sham Surgery | Sham Comparator | Control Sham Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB623 cells | Biological | SB623 cells will be implanted in the peri-infarct area using stereotactic surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel C Lu, MD, PhD | University of California, Los Angeles, Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center (Surgical/Assessment) | Los Angeles | California | 90095 | United States | ||
| Ronald Reagan UCLA Medical Denter |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39231380 | Derived | Okonkwo DO, McAllister P, Achrol AS, Karasawa Y, Kawabori M, Cramer SC, Lai A, Kesari S, Frishberg BM, Groysman LI, Kim AS, Schwartz NE, Chen JW, Imai H, Yasuhara T, Chida D, Nejadnik B, Bates D, Stonehouse AH, Richardson RM, Steinberg GK, Poggio EC, Weintraub AH. Mesenchymal Stromal Cell Implants for Chronic Motor Deficits After Traumatic Brain Injury: Post Hoc Analysis of a Randomized Trial. Neurology. 2024 Oct 8;103(7):e209797. doi: 10.1212/WNL.0000000000209797. Epub 2024 Sep 4. | |
| 34402352 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group: SB623 2.5 Million Cells | 2.5 million SB623 cells SB623 surgically implanted |
| FG001 | Treatment Group: SB623 5 Million Cells | 5 million SB623 cells SB623 surgically implanted |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2018 | Jul 10, 2020 |
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| Sham Control | Procedure | Sham Surgery |
|
| 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. | 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. | 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. | 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
| 24 weeks |
| Los Angeles |
| California |
| United States |
| The Research Center of Southern California, LLC (Assessment) | Oceanside | California | 92056 | United States |
| University of California, Irvine (Assessment/Surgical) | Orange | California | 92868 | United States |
| Westview Clinical Research (Assessment) | Placentia | California | 92870 | United States |
| Providence Saint John's Health Center | Santa Monica | California | 90404 | United States |
| John Wayne Cancer Institute at Providence St. Johns Health Center | Santa Monica | California | United States |
| Stanford Health Care (Surgical/Assessment) | Stanford | California | 94305 | United States |
| Craig Hospital | Englewood | Colorado | 80113 | United States |
| Ki Health Partners, LLC dba New England Institute for Clinical Research (Assessment) | Stamford | Connecticut | 06905 | United States |
| SouthCoast Research Center | Miami | Florida | 33136 | United States |
| Midtown Neurology, PC (Assessment) | Atlanta | Georgia | 30312 | United States |
| Emory University Hospital (Surgical) | Atlanta | Georgia | 30322 | United States |
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| Shirley Ryan Ability Lab | Chicago | Illinois | United States |
| NYU Langone Medical Center (Surgical/Assessment) | New York | New York | 10016 | United States |
| New York University Langone Medical Center | New York | New York | United States |
| Burke Rehab Center (Assessment) | White Plains | New York | 10605 | United States |
| Ohio Health Research | Columbus | Ohio | 43214 | United States |
| Moss Rehab (Assessment) | Elkins Park | Pennsylvania | 19027 | United States |
| University of Pittsburgh Medical Center (Surgical/Assessment) | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | United States |
| Medical University of South Carolina (Surgical) | Charleston | South Carolina | 29425 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| Mid-Columbia Research | Richland | Washington | 99352 | United States |
| Hokkaido University Hospital (Surgical/Assessment) | Sapporo | Hokkaido | 060-8648 | Japan |
| Yokohama City University Hospital (Surgical/Assessment) | Yokohama | Kanagawa | 236-0004 | Japan |
| Okayama University Hospital (Assessment/Surgical) | Okayama | Okayama-ken | 700-8655 | Japan |
| Osaka University Hospital (Assessment/Surgical) | Suita | Osaka | 565-0871 | Japan |
| University of Tokyo Hospital (Assessment/Surgical) | Bunkyo | Tokyo | 113-8655 | Japan |
| Hokkaido University Hospital | Hokkaido | Japan |
| Okayama University Hospital | Okayama | Japan |
| Osaka University Hospital | Osaka | Japan |
| University of Tokyo Hospital | Tokyo | Japan |
| Yokohama City University Hospital | Yokohama | Japan |
| Clinical Hospital Feofaniia | Kiev | 03680 | Ukraine |
| Derived |
| 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. |
| 33397772 | Derived | Kawabori M, Weintraub AH, Imai H, Zinkevych I, McAllister P, Steinberg GK, Frishberg BM, Yasuhara T, Chen JW, Cramer SC, Achrol AS, Schwartz NE, Suenaga J, Lu DC, Semeniv I, Nakamura H, Kondziolka D, Chida D, Kaneko T, Karasawa Y, Paadre S, Nejadnik B, Bates D, Stonehouse AH, Richardson RM, Okonkwo DO. Cell Therapy for Chronic TBI: Interim Analysis of the Randomized Controlled STEMTRA Trial. Neurology. 2021 Feb 22;96(8):e1202-e1214. doi: 10.1212/WNL.0000000000011450. |
| FG002 | Treatment Group: SB623 10 Million Cells | 10 million SB623 cells SB623 surgically implanted |
| FG003 | Treatment Group: Sham Surgery | Control Sham Surgery Sham Control: Sham Surgery |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group: 2.5 Million Cells | 2.5 million SB623 cells SB623 surgically implanted |
| BG001 | Treatment Group: 5 Million Cells | 5 million SB623 cells SB623 surgically implanted |
| BG002 | Treatment Group: 10 Million Cells | 10 million SB623 cells SB623 surgically implanted |
| BG003 | Sham Surgery | Control Sham Surgery Sham Control: Sham Surgery |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure (61 subjects) | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 24 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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:
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). | The Modified Intent-to-Treat (mITT) population included all randomized subjects who completed the surgery treatment procedure. Only subjects in the mITT population who have the value available for Change from Baseline in DRS at 24 weeks are included in this analysis. | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Modified Intent-to-Treat (mITT) population included all randomized subjects who completed the surgery treatment procedure. Only subjects in the mITT population who have the value available for Change from Baseline in ARAT at 24 weeks are included in this analysis. | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Modified Intent-to-Treat (mITT) population included all randomized subjects who completed the surgery treatment procedure. Only subjects in the mITT population who have the value available for Change from Baseline in Gait Velocity at 24 weeks are included in this analysis. | Posted | Mean | Standard Deviation | 10 meter walk change of time in seconds | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Modified Intent-to-Treat (mITT) population included all randomized subjects who completed the surgery treatment procedure. Only subjects in the mITT population who have the value available for Change from Baseline in NeuroQOL T-scores at 24 weeks are included in this analysis. | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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
| Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure | Posted | Count of Participants | Participants | 24 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group: SB623 2.5 Million Cells | 2.5 million SB623 cells SB623 surgically implanted | 0 | 15 | 1 | 15 | 15 | 15 |
| EG001 | Treatment Group: SB623 5 Million Cells | 5 million SB623 cells SB623 surgically implanted | 0 | 15 | 1 | 15 | 15 | 15 |
| EG002 | Treatment Group: SB623 10 Million Cells | 10 million SB623 cells SB623 surgically implanted | 0 | 16 | 2 | 16 | 16 | 16 |
| EG003 | Sham Surgery | Control Sham Surgery Sham Control: Sham Surgery | 0 | 15 | 3 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Balance disorder | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural headache | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Head discomfort | Nervous system disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bijan Nejadnik M.D.; Chief Medical Officer | SanBio, Inc. | 650-625-2205 | Bijan.Nejadnik@sanbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2019 | Oct 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Sham Surgery | Control Sham Surgery Sham Control: Sham Surgery |
|
|
|
| OG003 | Sham Surgery | Control Sham Surgery Sham Control: Sham Surgery |
|
|
|
|
|
|
| Treatment Group: SB623 10 Million Cells |
10 million SB623 cells SB623 surgically implanted |
| OG003 | Sham Surgery | Control Sham Surgery Sham Control: Sham Surgery |
|
|
|
| OG002 |
| Treatment Group: SB623 10 Million Cells |
10 million SB623 cells SB623 surgically implanted |
| OG003 | Sham Surgery | Control Sham Surgery Sham Control: Sham Surgery |
|
|
| Scoring either 6 or 7 on the Global Rating (No) |
|