Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
5 participants
INTERVENTIONAL
2026-04-30
2027-05-31
Brief Summary
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* 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.
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Detailed Description
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* 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)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CRIS100 treatment
Administration of a single dose of CRIS100
CRIS100
local application of CRIS100
Interventions
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CRIS100
local application of CRIS100
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Cristália Produtos Químicos Farmacêuticos Ltda.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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CRT100
Identifier Type: -
Identifier Source: org_study_id
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