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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious adverse events (SAE)', 'timeFrame': '6 months', 'description': 'Possible, probable, or definitely CRIS 100-related SAE'}, {'measure': 'Anti-drug antibodies (ADA)', 'timeFrame': '6 months', 'description': 'Developing anti-CRIS100 antibodies'}, {'measure': 'Liver function', 'timeFrame': '6 months', 'description': 'Liver enzyme values more than 2 times higher than the upper limit of normal.'}, {'measure': 'Kidney function', 'timeFrame': '6 months', 'description': 'Plasma urea and/or creatinine concentration above 2 times the upper limit of normality'}, {'measure': 'White blood cell (WBC)', 'timeFrame': '6 months', 'description': 'Increase in WBC count greater than 20% of the upper limit of normal'}, {'measure': 'Hemoglobin', 'timeFrame': '6 months', 'description': 'Decrease in hemoglobin concentration greater than 20% of the lower limit of normal'}, {'measure': 'Imaging exams', 'timeFrame': '6 months', 'description': 'Changes in spinal cord imaging (MRI or CT) that indicate worsening of the primary lesion'}], 'secondaryOutcomes': [{'measure': 'Efficacy of CRIS100', 'timeFrame': '6 months', 'description': 'Improvement in AIS grade of one or more levels according to ISNCSCI.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': '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:\n\n* safety of CRIS100\n* efficacy of CRIS100\n\nParticipants will receive 75 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.', 'detailedDescription': 'Participants with complete spinal cord injury between T2 and T10 (ASIA A, according to ISNCSCI, 2019 revision) and:\n\n* occurred less than 72 hours ago\n* with surgical indication\n* bulbocavernous reflex present\n* who can receive treatment with CRIS100 within 72 hours after the trauma (preferably within 24 hours)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signature of the Free and Informed Consent Term by the participant or legal guardian\n* Age between 18 and 70 years old;\n* Thoracic spinal cord injury between T2 and T10, with surgical indication, occurred less than 72 hours before surgery;\n* Presence of bulbo cavernosum reflex;\n* Patients with a lesion classified as ASIA A according to the ISNCSCI (2019 revision);\n\nExclusion Criteria:\n\n* Absence of bulbocavernous reflex up to 72 hours after the trauma.\n* Presence of severe brain trauma.\n* Patients with lesions above T2 or below T10.\n* More than one site of spinal cord injury.\n* History of alcohol or illicit drug abuse, as defined by DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition or later).\n* Patients who need permanent mechanical respiratory support.\n* Polytraumatized patients who, in the investigator's assessment, compromise the neurological evolution.\n* Neurological diseases or functional dependence of any etiology prior to the trauma.\n* Any other comorbidity that, at the discretion of the investigator, makes it impossible to include the patient in the study."}, 'identificationModule': {'nctId': 'NCT05739734', 'briefTitle': 'Safety of CRIS100 on Treatment Spinal Cord Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cristália Produtos Químicos Farmacêuticos Ltda.'}, 'officialTitle': 'Clinical Safety Study of the Application of CRIS100 in Participants With Acute Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'CRT100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRIS100 treatment', 'description': 'Administration of a single dose of CRIS100', 'interventionNames': ['Drug: CRIS100']}], 'interventions': [{'name': 'CRIS100', 'type': 'DRUG', 'description': 'local application of CRIS100', 'armGroupLabels': ['CRIS100 treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jorge B Afiúne, MD', 'role': 'CONTACT', 'email': 'jorgeafiune@cristalia.com.br', 'phone': '+55 11 98364 5551'}, {'name': 'Odaly Toffoletto, PhD', 'role': 'CONTACT', 'email': 'odaly.toffoletto@cristalia.com.br', 'phone': '+55 11 98319 9668'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cristália Produtos Químicos Farmacêuticos Ltda.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}