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Authors
Wanner, Ina-Beate
Halford, Julia
Lopez, Jonathan
Shen, Sean
Chen, Yu
Zhao, Hayden
Salas, Carolina
Loo, Rachel Ogorzalek
Robicsek, Steven
Ellingson, Benjamin M.
Gornbein, Jeffrey
Van Meter, Timothy E.
Shaw, Gerry
Loo, Joseph A.
Vespa, Paul M.
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Funding
Funding for this research was provided by:
Dana Foundation (“First in man” award # 20182601: “Clinical study and trauma culture model experiments”)
Dana Foundation (Clinical Neuroscience “First in man” award # 20182601: “Clinical study and trauma culture model experiments”)
Brain Injury Research Center (BIRC), State of California (“Clinical study and trauma culture model experiments”)
Brain Injury Research Center (BIRC), State of California (“Clinical study and trauma culture model experiments”)
National Institute of Health (NIH), Institute of Neuronal Disorders and Stroke (NINDS), Small Business Innovation Research, SBIR (# 1R43NS106972-01 “Validation and GFAP proteoform characterization for assay use”)
National Institute of Health (NIH), Institute of Neuronal Disorders and Stroke (NINDS), Small Business Innovation Research, SBIR (# 1R43NS106972-01 “Validation and GFAP proteoform characterization for assay use”)
Abbott Diagnostics (Sponsored Research Agreement: “GFAP fragment analyses”)
Abbott Diagnostics (Sponsored Research Agreement: “GFAP fragment analyses”)
BRAINBox Solutions Inc., Richmond VA, USA (Sponsored Research Agreement: “Validation studies and patent licensing”)
National Institute of Health (NIH), Institute of Neuronal Disorders and Stroke (R01 NS052831 “Biochemical markers of severe traumatic brain injury”)
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Article History
Received: 10 November 2025
Accepted: 21 January 2026
First Online: 24 April 2026
Declarations
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: For deidentified TBI patient’s CSF and serum collection with metadata, adult patients (> 18 years of age) were enrolled at two Level 1 trauma centers, in Los Angeles, California, at the UCLA Ronald Reagan Hospital Neuro-Intensive Care Unit, and in Gainesville, Florida (UF Health Shands Hospital, University of Florida). The human subjects’ protocols included local IRBs that approved informed consent procedures at UCLA under Chair Paul Vespa and at the University of Florida Dept of Anesthesiology under Dr. Steven Robicsek. The Study “Biochemical markers for traumatic brain injury tissue and data bank” was approved by the Institutional Review Board (IRB) of the University of Florida with the IRB# 201703310. Patients met inclusion criteria if they were 18 years old with a non-penetrating head injury and had a GCS < 8 requiring the placement of an intraventricular catheter. Patients were excluded if they had a history of preexisting end-stage organ disease or severe psychiatric illness. At UCLA, the Office for Human Research Protection (OHRP) approved the informed consent protocol for the Brain Injury Research Center study with the BIRC-IRB# 10–0929. For deidentified fetal cerebral astrocyte cell cultures, the UCLA Office for Protection of Research Subject (OPRS) declared IRB exemption status for pre-shelved fetal brain specimen donation per HS-7 exemption amendment. Deidentified human fetal brain tissue from voluntarily aborted pregnancies was donated adhering to stringent ethical regulations. Tissue was preshelved at the UCLA Translational Pathology Core Laboratory (Sara Dry, Chair of Pathology and Laboratory Medicine). Consent was established through UCLA Dept of OB-GYN (Angela Chen, Division Chief of Family Planning). Signed informed consent occurred after decision on elective termination, complying with US Public Law 103–43 and NIH policy, ensuring no incentive (The Public Health Service Act, 42 U.S.C. § 289 g-2).
: This manuscript contains no individual personal information, so individual consent for publication is not applicable. All authors have read and approved the manuscript in its present version.
: IBW and JAL are inventors of the following patents licensed to BRAINBox Solutions Inc., where TVM serves as Chief Scientific Officer (CSO). GS is CEO and founder of EnCor Biotechnology Inc., which distributes several monoclonal GFAP antibodies used in this study. US Patent Issue No.: US 10,557,859 B2 original patent; Inventors IBW and JAL, Issue date: 2/11/2020; 25 claims prior publication 12/20/2018: “Astrocyte traumatome and neurotrauma biomarkers”. Applicant Regents of the University of California, Oakland, CA. Licensee: BRAINBox Solutions Inc. US Issue No.: US 11,249,094 B2 Additional 13 claims in divisional patent 13 Claims, Filed 12/116/2019; Issue date: 2/15/2022; Inventors: IBW and JAL, UCLA “Astrocyte traumatome and neurotrauma biomarkers”. Assignee UCLA; Licensee: Brain Box Solutions Inc.
