Safety of CRIS100 on Treatment Spinal Cord Injury

• Status: Not yet recruiting
• Trial end date: 2024-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Criteria

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.