Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-31 @ 3:55 AM
Study NCT ID:
NCT04559295
Status:
UNKNOWN
Last Update Posted:
2020-09-22
First Post:
2020-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D011843', 'term': 'Radiculopathy'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Independent Observer was blinded as to wether a subject received treatment or was in the control group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Two Years', 'description': 'The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).'}], 'secondaryOutcomes': [{'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': 'Two Years', 'description': 'The NRS consists of a numeric version of the visual analog scale. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. Scale for NRS is from 0 (best) - 10 (worst).'}, {'measure': 'Visual Analog Scale (VAS) for back pain', 'timeFrame': 'Two Years', 'description': 'When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for back pain is from 0 (best) - 10 (worst).'}, {'measure': 'Visual Analog Scale (VAS) for leg pain', 'timeFrame': 'Two Years', 'description': 'When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for leg pain is from 0 (best) - 10 (worst).'}, {'measure': 'PROMIS Physical Health', 'timeFrame': 'Two Years', 'description': 'The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Physical Health is from 16.2 (worst) - 67.7 (best)'}, {'measure': 'PROMIS Mental Health', 'timeFrame': 'Two Years', 'description': 'The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Mental Health is from 21.2 (worst) - 67.6 (best).'}, {'measure': 'North American Spine Society (NASS) for patient satisfaction', 'timeFrame': 'Two Years', 'description': 'The North American Spine Society (NASS) developed an outcome assessment instrument to measure diverse dimensions of the impact of lumbar spine problems. Scale range is from 1 to 4 (best to worst).'}, {'measure': 'EURO Quality of Life (EuroQol)', 'timeFrame': 'Two Years', 'description': 'EuroQol is an instrument which evaluates the generic quality of life developed in Europe and widely used. Scale is from 0.33 (worst - 0.88 (best).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stem cells', 'Bone marrow concentrate', 'Disc', 'Minimally invasive', 'Injections', 'Facet joint', 'Sacroiliac joint', 'Epidural space'], 'conditions': ['Low Back Pain', 'Disc Disease', 'Disc Degeneration', 'Arthropathy Vertebrae', 'Sacral Disorder', 'Radiculopathy', 'Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints', 'detailedDescription': "To study if the outcomes for the injection of bone marrow concentrate (BMC) in patients with disc, facet, epidural space, and sacroiliac joint pain create a clinically meaningful improvement in pain and function. Further analysis will determine if there be any variance in patient reported outcome due to the individual's pre-procedure cell count and analysis.\n\nHypothesis 1: An injection of autologous BMC into discs, facets, sacroiliac joints, and epidural space will improve pain and function in patients with IDD\n\nHypothesis 2: There will be a direct relationship between an individual's BMC composition and the patient's reported outcomes"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without protrusions/herniations and facet/sacroiliac joint pain\n* Patients with mild to severe spinal stenosis\n* Patients with radiculopathy\n* Patients with disc extrusions\n* Patients with failed spinal fusion\n* Patients with mild to severe facet arthropathy\n* Patients with suspected sacroiliac joint disease\n* Age 18 to 60 years\n* Mild to severe loss of intervertebral disc height\n* Pain is not responsive to conservative treatment measures (oral medication, epidural steroid injections, physical therapy)\n* Pain persists for an extended period of time (i.e., at least 3 months)\n* High intensity zone (HIZ) in annular fissure or adjacent to annular fissure detected on T2 or STIR MRI\n* No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer\n* English speaking\n\nExclusion Criteria:\n\n* Spinal Deformity (Scoliosis \\>20 degrees, Spondylolisthesis)\n* Sequestered fragments, severe thecal sac compression\n* Severe neurologic deficit\n* Non-English speaking\n* Bone marrow disorders\n* Immunosuppressed Patients\n* Patients with coagulopathy\n* Localized infection in the area of skin penetration\n* Spinal infection\n* Serious medical co-morbidities'}, 'identificationModule': {'nctId': 'NCT04559295', 'briefTitle': 'Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs', 'organization': {'class': 'OTHER', 'fullName': 'Stem Cures'}, 'officialTitle': 'Study of Bone of Marrow Concentrate (BMC) Injection in Discs, Facets, Sacroiliac Joints, and Epidural Space for Chronic Lower Back Pain With and Without Radiculopathy', 'orgStudyIdInfo': {'id': 'Regen_003-1018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem Cells (BMC)', 'description': 'Subjects in the BMC arm received an injection of bone marrow concentrate', 'interventionNames': ['Biological: Bone Marrow Concentrate']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects in the control arm received no treatment for their condition'}], 'interventions': [{'name': 'Bone Marrow Concentrate', 'type': 'BIOLOGICAL', 'otherNames': ['Stem Cells'], 'description': 'The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints', 'armGroupLabels': ['Stem Cells (BMC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45230', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Stem Cures', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Sairam Atluri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stem Cures'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stem Cures', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}