Safety of CRIS100 on Treatment Spinal Cord Injury (NCT05739734) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Safety of CRIS100 on Treatment Spinal Cord Injury
5 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.