Safety of CRIS100 on Treatment Spinal Cord Injury

Study Overview
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Brief Summary
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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 75 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.

Detailed Description
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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)

Official Title
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Clinical Safety Study of the Application of CRIS100 in Participants With Acute Spinal Cord Injury

Conditions
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Thoracic Spinal Cord Injury

Intervention / Treatment
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* Drug: CRIS100


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRIS100 treatment<br>Administration of a single dose of CRIS100 | Drug: CRIS100<br>* local application of CRIS100<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events (SAE) | Possible, probable, or definitely CRIS 100-related SAE | 6 months | 
| Anti-drug antibodies (ADA) | Developing anti-CRIS100 antibodies | 6 months | 
| Liver function | Liver enzyme values more than 2 times higher than the upper limit of normal. | 6 months | 
| Kidney function | Plasma urea and/or creatinine concentration above 2 times the upper limit of normality | 6 months | 
| White blood cell (WBC) | Increase in WBC count greater than 20% of the upper limit of normal | 6 months | 
| Hemoglobin | Decrease in hemoglobin concentration greater than 20% of the lower limit of normal | 6 months | 
| Imaging exams | Changes in spinal cord imaging (MRI or CT) that indicate worsening of the primary lesion | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of CRIS100 | Improvement in AIS grade of one or more levels according to ISNCSCI. | 6 months |