A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)
NCT ID: NCT02416492
Last Updated: 2021-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2016-07-06
2019-03-05
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SB623 Cells
SB623 Cells: 2.5, 5 or 10 million cells
SB623 cells
SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
Sham Surgery
Control Sham Surgery
Sham Control
Sham Surgery
Interventions
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SB623 cells
SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
Sham Control
Sham Surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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SanBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel C Lu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles, Department of Neurosurgery
Locations
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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
SouthCoast Research Center
Miami, Florida, United States
Midtown Neurology, PC (Assessment)
Atlanta, Georgia, United States
Emory University Hospital (Surgical)
Atlanta, Georgia, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Shirley Ryan Ability Lab
Chicago, Illinois, United States
NYU Langone Medical Center (Surgical/Assessment)
New York, New York, United States
New York University Langone Medical Center
New York, New York, United States
Burke Rehab Center (Assessment)
White Plains, New York, United States
Ohio Health Research
Columbus, Ohio, United States
Moss Rehab (Assessment)
Elkins Park, Pennsylvania, United States
University of Pittsburgh Medical Center (Surgical/Assessment)
Pittsburgh, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (Surgical)
Charleston, South Carolina, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Mid-Columbia Research
Richland, Washington, United States
Hokkaido University Hospital (Surgical/Assessment)
Sapporo, Hokkaido, Japan
Yokohama City University Hospital (Surgical/Assessment)
Yokohama, Kanagawa, Japan
Okayama University Hospital (Assessment/Surgical)
Okayama, Okayama-ken, Japan
Osaka University Hospital (Assessment/Surgical)
Suita, Osaka, Japan
University of Tokyo Hospital (Assessment/Surgical)
Bunkyo, Tokyo, 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, , Ukraine
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TBI-01
Identifier Type: -
Identifier Source: org_study_id