MicroRNA Biomarkers for Traumatic Brain Injury and Methods of Use Thereof
AssigneesThe Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., University of Florida Research Foundation, Inc., Orlando Health, Inc., d/b/a Orlando Regional Medical Center
InventorsRadha K. MAHESHWARI, Nagaraja S. BALAKATHIRESAN, Manish BHOMIA, Kevin K. WANG, Linda PAPA
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Abstract
The present invention relates to methods of diagnosing traumatic brain injury (TBI) in a subject. The present invention also relates to methods of monitoring the progression of the TBI in a subject.
Claims35
A method of diagnosing traumatic brain injury (TBI) in a subject, the method comprising
- a) determining a level(s) of one or more micro RNAs (miRNAs) comprising hsa-miR-151-5p and/or miR-9* in a biological sample taken from the subject, and
- b) comparing the determined level(s) of the one or more miRNAs against a level(s) of the same one or more miRNAs from a control subject determined not to be suffering from TBI,
- wherein an increase in the level(s) of the one or more miRNAs compared to the level(s) of the one or more miRNAs-from the control subject determined not to be suffering from TBI is indicative that the subject is suffering from TBI.
-5. (canceled)
-10. (canceled)
(canceled)
A method of monitoring the progression of traumatic brain injury (TBI) in a subject, the method comprising
- a) analyzing at least two biological samples from the subject taken at different time points to determine a level(s) of one or more micro RNAs (miRNAs) comprising hsa-miR-151-5p and/or miR-9* in each of the at least two biological samples, and
- b) comparing the determined level(s) of the one or more miRNAs over time to determine if the subject's level(s) of the one or more miRNAs is changing over time,
- wherein an increase in the level(s) of the one or more miRNAs over time is indicative that the subject's risk of suffering from TBI is increasing over time.
-24. (canceled)
-29. (canceled)
(canceled)
A method of detecting a microRNA or plurality of microRNA's in a biological sample, comprising:
- obtaining a first biological sample from a subject presenting with or without clinical symptoms of a traumatic brain injury;
- contacting said first biological sample with a probe for binding at least one microRNA comprising hsa-miR-151-5p and/or hsa-miR-9*, to produce an microRNA-cDNA protein complex, and
- detecting the presence or absence of the microRNA-cDNA complex, wherein the absence of the complex is indicative of the absence of the microRNA in the first biological sample.
(canceled)
A method of detecting one or more microRNA (miRNA) in a human subject with a head injury, the method comprising:
- (a) obtaining a serum, saliva, or cerebrospinal fluid biological sample from the human subject,
- (b) measuring the level of one or more miRNA comprising hsa-miR-151-5p and/or miR-9* in the serum, saliva, or cerebrospinal fluid biological sample, and
- (c) generating a recommendation for a computed tomography (CT) scan of the subject's head if the level of hsa-miR-151-5p and/or miR-9* has an increase of four-fold or more compared to a level of hsa-miR-151-5p and/or miR-9* in a biological sample from a human control subject determined not to be suffering from TBI;
- wherein an increase of up to about 10 fold in the level of hsa-miR-151-5p and/or miR-9* compared to the level of hsa-miR-151-5p and/or miR-9* in a biological sample from a human control subject determined not to be suffering from TBI indicates that the human subject with the head injury is suffering from mild TBI, and an increase of between about 10 fold and about 15 fold in the level of hsa-miR-151-5p and/or miR-9* compared to the level of hsa-miR-151-5p and/or miR-9* in a biological sample from a human control subject determined not to be suffering from TBI indicates that the human subject with the head injury is suffering from severe TBI.
Dependencies are inferred from the claim text.