Safety of CRIS100 on Treatment Spinal Cord Injury

Thoracic Spinal Cord Injury Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Thoracic Spinal Cord Injury
• Wounds and Injuries

• NCT number: NCT05739734
• Study type: Interventional
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: Jorge B Afiúne, MD
• Phone: +55 11 98364 5551
• Email: jorgeafiune@cristalia.com.br
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 15, 2023
• Completion date: September 15, 2024