Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 11:50 AM
Study NCT ID:
NCT03644251
Status:
TERMINATED
Last Update Posted:
2019-03-15
First Post:
2018-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FLO for Discogenic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study Site Ceased all Business Operations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in patient back pain determined by visual analog scale', 'timeFrame': '3 months', 'description': '0 to 100mm, 100mm worst pain'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life determined by SF-36', 'timeFrame': '3 and 6 months', 'description': 'Short FormHealth Survey to evaluate quality of life across eight scales'}, {'measure': 'Change in patient back pain determined by visual analog scale', 'timeFrame': '6 months', 'description': '0 to 100mm, 100mm worst pain'}, {'measure': 'Change in Oswestry Disability Index', 'timeFrame': '3 and 6 months', 'description': '0 to 50, higher the percentile, the worse the perceived lower back pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Discogenic Back Pain']}, 'descriptionModule': {'briefSummary': 'Discogenic pain is pain originating from a damaged vertebral disc and be caused by inflammation, dehydration of the nucleus pulposus, decreased disc height, annular tears and impaired mechanical function of the disc.Non-operative treatment may include traction, steroid therapy, methylene blue injection and ablative therapy. However, there are few high quality studies evaluating these treatments for reducing discogenic low back pain and most clinical trials failed to detect significant differences between treatments and placebo therapies. Hence, there remains an unmet clinical need.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject (male or female) is at least 18 to 70 years of age\n* diagnosed with single level discogenic back pain confirmed by MRI and positive discography per Spine Interventional Society Guidelines\n* Diagnosis of disc degeneration with Pfirrmann score of 1-3\n* Subject has failed at least six months of conservative care\n* Subject is symptomatic with axial lower back pain greater than lower limb pain at the intensity of \\>6/10 concordant or partially concordant\n* The subject is able to comply with all post-operative standard of care and follow instructions.\n\nExclusion Criteria:\n\n* Subjects has significant disc protrusion, severe lumbar spinal stenosis, spine tumor, severe disc degeneration, or Sacroiliac (SI) joint syndrome\n* Subject had previous surgery at the disc level\n* Patient has previously received injection of FLO within 3 months of screening\n* The subject is unable to comply with follow-up or not appropriate for inclusion based on investigator decision'}, 'identificationModule': {'nctId': 'NCT03644251', 'briefTitle': 'FLO for Discogenic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioTissue Holdings, Inc'}, 'officialTitle': 'FLO Injection for Discogenic Pain', 'orgStudyIdInfo': {'id': 'CLARIX-CS003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMUC Dosage 1', 'description': '25mg amniotic and umbilical cord matrix', 'interventionNames': ['Other: amniotic and umbilical cord matrix']}, {'type': 'EXPERIMENTAL', 'label': 'AMUC Dosage 2', 'description': '50mg amniotic and umbilical cord matrix', 'interventionNames': ['Other: amniotic and umbilical cord matrix']}, {'type': 'EXPERIMENTAL', 'label': 'AMUC Dosage 3', 'description': '100mg amniotic and umbilical cord matrix', 'interventionNames': ['Other: amniotic and umbilical cord matrix']}], 'interventions': [{'name': 'amniotic and umbilical cord matrix', 'type': 'OTHER', 'description': 'Cryopreserved human amniotic and umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability.', 'armGroupLabels': ['AMUC Dosage 1', 'AMUC Dosage 2', 'AMUC Dosage 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Laser Spine Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioTissue Holdings, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}