Safety of CRIS100 on Treatment Spinal Cord Injury

NCT05739734 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: CRT100
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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

Conditions

Thoracic Spinal Cord Injury

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Efficacy of CRIS100

  6 months

Study Arms (1)

CRIS100 treatment

EXPERIMENTAL

Administration of a single dose of CRIS100

Drug: CRIS100

Interventions

CRIS100 DRUG

local application of CRIS100

CRIS100 treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.: lead

Central Study Contacts

Jorge B Afiune, MD

CONTACT

+55 11 98364 5551; jorgeafiune@cristalia.com.br

Patricia C Bombarda, Post Graduate

CONTACT

+551146135119; patricia.bombarda@cristalia.com.br

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 22, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share