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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05739734
• Other study ID #: CRT100
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 15, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: February 2023
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: Jorge B Afiúne, MD
• Phone: +55 11 98364 5551
• Email: jorgeafiune[@]cristalia.com.br
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: September 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• CRIS100
local application of CRIS100

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cristália Produtos Químicos Farmacêuticos Ltda.

Outcome

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