Safety of CRIS100 on Treatment Spinal Cord Injury

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

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 100 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracic Spinal Cord Injury
• Intervention / Treatment: Drug: CRIS100

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 Type: Interventional
• Enrollment (Estimated): 5
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jorge B Afiune, MD; Phone Number: +55 11 98364 5551; Email: jorgeafiune@cristalia.com.br
• Study Contact Backup: Name: Patricia C Bombarda, Post Graduate; Phone Number: +551146135119; Email: patricia.bombarda@cristalia.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRIS100 treatment; Administration of a single dose of CRIS100	Drug: CRIS100; local application of CRIS100

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of CRIS100	Improvement in AIS grade of one or more levels according to ISNCSCI.	6 months

Collaborators and Investigators

• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: CRT100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No