Safety of CRIS100 on Treatment Spinal Cord Injury

Early Phase 1

Not yet recruiting

• Conditions: Thoracic Spinal Cord Injury
• Interventions: Drug: CRIS100

• Registration Number: NCT05739734
• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Brief 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.

Detailed 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)

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Study Start: 2023-05-15
• Primary Completion: 2024-06-15
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRIS100 treatment	CRIS100	Administration of a single dose of CRIS100

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy of CRIS100	6 months	Improvement in AIS grade of one or more levels according to ISNCSCI.