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Safety of CRT100 on Treatment Spinal Cord Injury

RecruitingPhase 1Ages 18 Years - 70 YearsAllCristália Produtos Químicos Farmacêuticos Ltda.
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to test CRT100 treatment in participants with acute thoracic spinal cord injury. The main questions it aims to answer is safety of CRT100. Participants will receive 100 mcg CRT100 in the zone of the spinal injury, within 72 hours of the trauma.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. * 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.
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What it tests

  • CRT100
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Where

3 sites
ISanta
São Paulo, Brazil
AACD
São Paulo, Brazil
Institute of Orthopedics and Traumatology, Hospital das Clínicas, University of São Paulo Medical School (IOT-HCFMUSP)
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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