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Safety of CRIS100 on Treatment Spinal Cord Injury

Primary Purpose

Thoracic Spinal Cord Injury

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
CRIS100
Sponsored by
Cristália Produtos Químicos Farmacêuticos Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Spinal Cord Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CRIS100 treatment

    Arm Description

    Administration of a single dose of CRIS100

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Efficacy of CRIS100
    Improvement in AIS grade of one or more levels according to ISNCSCI.

    Full Information

    First Posted
    February 3, 2023
    Last Updated
    February 13, 2023
    Sponsor
    Cristália Produtos Químicos Farmacêuticos Ltda.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05739734
    Brief Title
    Safety of CRIS100 on Treatment Spinal Cord Injury
    Official Title
    Clinical Safety Study of the Application of CRIS100 in Participants With Acute Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    June 15, 2024 (Anticipated)
    Study Completion Date
    September 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cristália Produtos Químicos Farmacêuticos Ltda.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thoracic Spinal Cord Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Anticipated)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jorge B Afiúne, MD
    Phone
    +55 11 98364 5551
    Email
    jorgeafiune@cristalia.com.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Odaly Toffoletto, PhD
    Phone
    +55 11 98319 9668
    Email
    odaly.toffoletto@cristalia.com.br

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety of CRIS100 on Treatment Spinal Cord Injury

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