Thoracic Spinal Cord InjuryPhase 1CRT100NCT05739734
Safety of CRT100 on Treatment Spinal Cord Injury
A Phase 1 study testing CRT100 in people with Thoracic Spinal Cord Injury, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 3 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracic Spinal Cord Injury
- What is being tested?
- CRT100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesBrazil
- Study dates
- Sep 2026to Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil3 sites, 3 recruiting
- Not yet recruiting
ISanta
São Paulo, São Paulo, 01223-001
Robert Meves, MD, 55+11+2176-7712, isantacasa@santacasasp.org.br
- Enrolling by invitation
AACD
São Paulo, São Paulo, 04027-000
- Recruiting
Institute of Orthopedics and Traumatology, Hospital das Clínicas, University of São Paulo Medical School (IOT-HCFMUSP)
São Paulo, São Paulo, 05403-010
Alexandre Fogaça Cristante, MD, 55+11+2661-2011, alexandre.cristante@hc.fm.usp.br
About this study
Official title: Phase 1 Clinical Trial to Evaluate the Safety of CRT100 for the Treatment of Acute Spinal Cord Injury.
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.
Read the 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 CRT100 within 72 hours after the trauma (preferably within 24 hours)
- Conditions
- Thoracic Spinal Cord Injury
- Being tested
- CRT100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT100Drug
local application of CRT100
| Study group | Role | What they receive |
|---|---|---|
| CRT100 treatment | Experimental | Administration of a single dose of CRT100 Receives: Drug: CRT100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Assessed by the frequency and severity of adverse events occurring within 180 days following a single injection of CRT100
Measured: 6 months
Secondary outcomes (1)
Immunogenicity
Based on the detection of anti-drug antibodies (ADA)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739734
- Sponsor's protocol ID
- CRT100
- Acronym
- CRT100
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No