Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT05739734
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2023-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of CRIS100 on Treatment Spinal Cord Injury
Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Organization:
Study Overview
Official Title:
Clinical Safety Study of the Application of CRIS100 in Participants With Acute Spinal Cord Injury
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 75 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.
* safety of CRIS100
* efficacy of CRIS100
Participants will receive 75 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)
* 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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: