The goal of this clinical trial is to test CRIS100 treatment in participants with acute thoracic spinal cord injury. The main questions it aims to answer are: * safety of CRIS100 * efficacy of CRIS100 Participants will receive 100 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.
Participants with complete spinal cord injury between T2 and T10 (ASIA A, according to ISNCSCI, 2019 revision) and: * occurred less than 72 hours ago * with surgical indication * bulbocavernous reflex present * who can receive treatment with CRIS100 within 72 hours after the trauma (preferably within 24 hours)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
local application of CRIS100
Serious adverse events (SAE)
Possible, probable, or definitely CRIS 100-related SAE
Time frame: 6 months
Anti-drug antibodies (ADA)
Developing anti-CRIS100 antibodies
Time frame: 6 months
Liver function
Liver enzyme values more than 2 times higher than the upper limit of normal.
Time frame: 6 months
Kidney function
Plasma urea and/or creatinine concentration above 2 times the upper limit of normality
Time frame: 6 months
White blood cell (WBC)
Increase in WBC count greater than 20% of the upper limit of normal
Time frame: 6 months
Hemoglobin
Decrease in hemoglobin concentration greater than 20% of the lower limit of normal
Time frame: 6 months
Imaging exams
Changes in spinal cord imaging (MRI or CT) that indicate worsening of the primary lesion
Time frame: 6 months
Efficacy of CRIS100
Improvement in AIS grade of one or more levels according to ISNCSCI.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.