Trials / Not Yet Recruiting
Not Yet RecruitingNCT05739734
Safety of CRIS100 on Treatment Spinal Cord Injury
Clinical Safety Study of the Application of CRIS100 in Participants With Acute Spinal Cord Injury
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CRIS100 | local application of CRIS100 |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2023-02-22
- Last updated
- 2026-02-03
Source: ClinicalTrials.gov record NCT05739734. Inclusion in this directory is not an endorsement.