Safety of CRIS100 on Treatment Spinal Cord Injury

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)

Inclusion criteria

• Signature of the Free and Informed Consent Term by the participant or legal guardian
• Age between 18 and 70 years old;
• Thoracic spinal cord injury between T2 and T10, with surgical indication, occurred less than 72 hours before surgery;
• Presence of bulbo cavernosum reflex;
• Patients with a lesion classified as ASIA A according to the ISNCSCI (2019 revision);

Exclusion criteria

• Absence of bulbocavernous reflex up to 72 hours after the trauma.
• Presence of severe brain trauma.
• Patients with lesions above T2 or below T10.
• More than one site of spinal cord injury.
• History of alcohol or illicit drug abuse, as defined by DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition or later).
• Patients who need permanent mechanical respiratory support.
• Polytraumatized patients who, in the investigator's assessment, compromise the neurological evolution.
• Neurological diseases or functional dependence of any etiology prior to the trauma.
• Any other comorbidity that, at the discretion of the investigator, makes it impossible to include the patient in the study.