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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRIS100 treatment | Experimental | Administration of a single dose of CRIS100 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRIS100 | Drug | local application of CRIS100 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of CRIS100 | Improvement in AIS grade of one or more levels according to ISNCSCI. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge B Afiune, MD | Contact | +55 11 98364 5551 | jorgeafiune@cristalia.com.br | |
| Patricia C Bombarda, Post Graduate | Contact | +551146135119 | patricia.bombarda@cristalia.com.br |
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