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New drug CRIS100 tested for spinal cord injury safety

NCT ID NCT05739734

Disease control Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether a single dose of CRIS100 is safe for people with a recent spinal cord injury in the upper back. Only 5 adults with severe injuries will receive the drug directly at the injury site within 72 hours. The study focuses on side effects and lab changes, not on curing the injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thoracic spinal cord injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.