Polylaminin for Acute Spinal Cord Injury
Phase 1
Recruiting
- Conditions
- nspecified injury at unspecified level of cervical spinal cordUnspecified injury at unspecified level of thoracic spinal cordG00-G99
- Registration Number
- RBR-9dfvgpm
- Lead Sponsor
- niversidade Federal do Rio de Janeiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Age between 18 and 60 years old; patients bearing acute spinal cord injury (up to 72 hours) classified as AIS A; location of the lesion between C4 and T12
Exclusion Criteria
Severe brain trauma; lack of spinal surgery indication; need of permanent mechanical respiratory support; poly-trauma; previous diagnosis of neurological diseases (EX. Alzheimer, Amyotrophic Lateral Sclerosis, sequelae of Stroke); alcohol abuse or dependence
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method We expect the treatment with polylaminin to be safe as it does not promote either serious adverse effects or clinical/neurological worsening, verified by clinical examination and laboratory tests.<br>;We expect that the treatment with polylaminine will be effective in promoting AIS conversation from A to C or D (recovery of motor control) verified by neurological examination, with the null hypothesis that no convertion or convertion from A to B would occur from the pre-treatment baseline through the one year followup period<br><br> <br>
- Secondary Outcome Measures
Name Time Method We expect that the treatment with polylaminin induces the appearance of a detectable electrophysiological signal below the level of the lesion, verified by means of the motor evoked potential (MEP) exam, with the null hypothesis that no change would occur from the initial exam through the 1 year followup period<br><br><br>