Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT02412735
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christopher.James@Mesoblast.com', 'phone': '212-880-2060', 'title': 'Christopher James, VP Head of Clinical Operations', 'phoneExt': '7925', 'organization': 'Mesoblast, Inc.'}, 'certainAgreement': {'otherDetails': 'Publications (abstracts, posters or presentations) must be presented to the Publication Steering Committee for review prior to submission or public display and are not allowed prior to the publication of the primary manuscript, or eighteen (18) months from the conclusion of the Study. PI shall provide Sponsor a copy of any proposed public disclosure at least 30 days prior to submission. Sponsor may ask PI to delay the disclosure for a maximum of 60 days to file proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 38 months', 'description': 'All-cause Mortality: The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. Serious and Other (Non-serious) Adverse Events: Safety Analysis Set included all participants who were randomized and received treatment, and classified according to the actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 143, 'otherNumAffected': 111, 'seriousNumAtRisk': 140, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0 (Visit 2).', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 129, 'otherNumAffected': 100, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 132, 'otherNumAffected': 98, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Escherichia bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Perineurial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sacral radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Spinal meningeal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hepatic hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Eosinophilic oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza b virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Treatment Success: Bayesian Estimated Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'OG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.267', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '0.335', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '0.313', 'spread': '0.041', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.2072.'}, {'groupIds': ['OG001', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.6427.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 months', 'description': 'Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 \\[12 months post-treatment\\] and 8 \\[24 months post-treatment\\]). The average response rate (proportion of participants with response presented as Bayesian estimate\\[BE\\]) was based upon the average of multiple Bayesian simulations.', 'unitOfMeasure': 'BE proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.'}, {'type': 'SECONDARY', 'title': 'Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'OG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.352', 'spread': '0.041', 'groupId': 'OG000'}, {'value': '0.472', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '0.388', 'spread': '0.044', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.2754.'}, {'groupIds': ['OG001', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.9087.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 months', 'description': "A participant was defined as a pain responder for a given study visit if they achieved at least a 50% reduction from Baseline in the lower-back pain VAS score (average pain over 24 hours), as reported during in-clinic assessment. The participant should be qualified as a pain responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.", 'unitOfMeasure': 'BE proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.'}, {'type': 'SECONDARY', 'title': 'Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'OG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.378', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '0.409', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '0.413', 'spread': '0.044', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.2835.'}, {'groupIds': ['OG001', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.4739.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 months', 'description': "A participant was defined as a functional responder for a given study visit if they achieved at least a 15-point reduction from Baseline in ODI score, as reported during in-clinic assessment. The participant should be qualified as a functional responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up; any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.", 'unitOfMeasure': 'BE proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.'}, {'type': 'SECONDARY', 'title': 'Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'OG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.353', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '0.425', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '0.391', 'spread': '0.045', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.2650.'}, {'groupIds': ['OG001', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.7004.'}], 'paramType': 'MEAN', 'timeFrame': 'Month 24', 'description': 'A treatment responder with treatment success was defined as a participant who met the 3 conditions of a composite responder analysis as: 50% or greater reduction in the lower-back pain VAS score; 15-point or greater reduction in ODI score; and lack of post-treatment interventions at the treated level as of the study visit. The participants qualified as responders if they satisfied the above conditions at the 24-month follow-up visit alone. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.', 'unitOfMeasure': 'BE proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.'}, {'type': 'SECONDARY', 'title': 'Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'OG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.384', 'spread': '0.043', 'groupId': 'OG000'}, {'value': '0.495', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '0.438', 'spread': '0.046', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.1945.'}, {'groupIds': ['OG001', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.8093.'}], 'paramType': 'MEAN', 'timeFrame': 'Month 24', 'description': "A minimal pain responder was defined as a participant who achieved a lower-back pain VAS score (average pain over 24 hours) of 20 mm or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.", 'unitOfMeasure': 'BE proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.'}, {'type': 'SECONDARY', 'title': 'Effectiveness Based on Time to First Intervention Over 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'OG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1099', 'groupId': 'OG000'}, {'value': '0.1003', 'groupId': 'OG001'}, {'value': '0.0913', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7842', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.50', 'ciUpperLimit': '2.46', 'estimateComment': 'Hazard ratio and 95% confidence interval (CI) were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.'}, {'pValue': '0.8754', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.41', 'ciUpperLimit': '2.14', 'estimateComment': 'Hazard ratio and 95% CI were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 24', 'description': 'The effectiveness of the study drug was evaluated based on its ability in increasing the time to additional interventions at the treated level over 24 months post-treatment. Kaplan-Meier estimates for the probability (expressed as a percentage) of participants to receive an intervention are presented.', 'unitOfMeasure': 'percentage probability', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.'}, {'type': 'SECONDARY', 'title': 'Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'OG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.394', 'spread': '0.043', 'groupId': 'OG000'}, {'value': '0.367', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '0.440', 'spread': '0.045', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.2309.'}, {'groupIds': ['OG001', 'OG002'], 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority threshold was 0.9875.', 'otherAnalysisDescription': 'The posterior probability of superiority to placebo was 0.1241.'}], 'paramType': 'MEAN', 'timeFrame': 'Month 24', 'description': "A minimal disability responder was defined as a participant who achieved an ODI score of 20% or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.", 'unitOfMeasure': 'BE proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change From Baseline in Low Back Pain Visual Analog Scale (VAS) Score at 1, 3, 6, 12, 18, 24, and 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'OG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'classes': [{'title': 'Change from Baseline at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.6', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-17.3', 'spread': '2.30', 'groupId': 'OG001'}, {'value': '-13.9', 'spread': '2.32', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-19.1', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '-22.5', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '-17.6', 'spread': '2.40', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-22.4', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '-24.9', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '-18.6', 'spread': '2.48', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-23.3', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-27.4', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '-19.0', 'spread': '2.51', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-23.7', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-25.1', 'spread': '2.74', 'groupId': 'OG001'}, {'value': '-19.2', 'spread': '2.70', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-20.8', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '-25.9', 'spread': '2.74', 'groupId': 'OG001'}, {'value': '-18.3', 'spread': '2.70', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-22.9', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '-25.1', 'spread': '2.81', 'groupId': 'OG001'}, {'value': '-19.0', 'spread': '2.77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9072', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-5.71', 'ciUpperLimit': '6.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.08', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 1', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.2883', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-9.51', 'ciUpperLimit': '2.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.14', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 1', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.6314', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-7.90', 'ciUpperLimit': '4.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.23', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 3', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.1366', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-11.37', 'ciUpperLimit': '1.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.29', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 3', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.2497', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-10.43', 'ciUpperLimit': '2.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.34', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 6', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.0666', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.3', 'ciLowerLimit': '-13.00', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.42', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 6', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.2147', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-10.91', 'ciUpperLimit': '2.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.40', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.0162', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.4', 'ciLowerLimit': '-15.19', 'ciUpperLimit': '-1.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.47', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.2230', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-11.69', 'ciUpperLimit': '2.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.67', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 18', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.1152', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-13.27', 'ciUpperLimit': '1.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.74', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 18', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.4884', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-9.75', 'ciUpperLimit': '4.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.66', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.0426', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.6', 'ciLowerLimit': '-14.98', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.74', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.3056', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-11.27', 'ciUpperLimit': '3.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.77', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 36', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}, {'pValue': '0.1184', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.0', 'ciLowerLimit': '-13.59', 'ciUpperLimit': '1.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.85', 'groupDescription': 'Mean Change from Baseline in Low Back Pain VAS Score at Month 36', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\\&continuous covariate baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Months 1, 3, 6, 12, 18, 24, and 36', 'description': 'Pain intensity was recorded on a horizontal 100 mm VAS and measured as the distance in millimeters from the left origin of the horizontal VAS line and the point indicated by the participant as representing their level of pain. A horizontal 100 mm VAS anchored on the left with the words "No Pain" and on the right with the words "Worst Possible Pain", was used to measure low back pain intensity. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the participant to indicate the participant\'s level of pain. VAS ranges from 0 to 100, with higher scores indicating worst possible pain. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. Number analyzed is the number of participants with data available for analysis at the given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'FG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0 (Visit 2).'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Starting on March 6, 2015, a total of 404 participants were enrolled at investigative sites in Australia and the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '404', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).'}, {'id': 'BG001', 'title': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '10.81', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '11.66', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '10.45', 'groupId': 'BG002'}, {'value': '42.8', 'spread': '10.96', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '373', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '369', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-treat (ITT) Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-17', 'size': 5328412, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-15T16:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2021-05-24', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-22', 'studyFirstSubmitDate': '2015-03-25', 'dispFirstSubmitQcDate': '2021-05-24', 'resultsFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2015-04-06', 'dispFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-17', 'studyFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Change From Baseline in Low Back Pain Visual Analog Scale (VAS) Score at 1, 3, 6, 12, 18, 24, and 36 Months', 'timeFrame': 'Months 1, 3, 6, 12, 18, 24, and 36', 'description': 'Pain intensity was recorded on a horizontal 100 mm VAS and measured as the distance in millimeters from the left origin of the horizontal VAS line and the point indicated by the participant as representing their level of pain. A horizontal 100 mm VAS anchored on the left with the words "No Pain" and on the right with the words "Worst Possible Pain", was used to measure low back pain intensity. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the participant to indicate the participant\'s level of pain. VAS ranges from 0 to 100, with higher scores indicating worst possible pain. A negative change from baseline indicates improvement.'}], 'primaryOutcomes': [{'measure': 'Overall Treatment Success: Bayesian Estimated Response Rate', 'timeFrame': 'Up to 24 months', 'description': 'Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 \\[12 months post-treatment\\] and 8 \\[24 months post-treatment\\]). The average response rate (proportion of participants with response presented as Bayesian estimate\\[BE\\]) was based upon the average of multiple Bayesian simulations.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate', 'timeFrame': 'Up to 24 months', 'description': "A participant was defined as a pain responder for a given study visit if they achieved at least a 50% reduction from Baseline in the lower-back pain VAS score (average pain over 24 hours), as reported during in-clinic assessment. The participant should be qualified as a pain responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations."}, {'measure': 'Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate', 'timeFrame': 'Up to 24 months', 'description': "A participant was defined as a functional responder for a given study visit if they achieved at least a 15-point reduction from Baseline in ODI score, as reported during in-clinic assessment. The participant should be qualified as a functional responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up; any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations."}, {'measure': 'Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate', 'timeFrame': 'Month 24', 'description': 'A treatment responder with treatment success was defined as a participant who met the 3 conditions of a composite responder analysis as: 50% or greater reduction in the lower-back pain VAS score; 15-point or greater reduction in ODI score; and lack of post-treatment interventions at the treated level as of the study visit. The participants qualified as responders if they satisfied the above conditions at the 24-month follow-up visit alone. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.'}, {'measure': 'Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate', 'timeFrame': 'Month 24', 'description': "A minimal pain responder was defined as a participant who achieved a lower-back pain VAS score (average pain over 24 hours) of 20 mm or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations."}, {'measure': 'Effectiveness Based on Time to First Intervention Over 24 Months', 'timeFrame': 'Up to Month 24', 'description': 'The effectiveness of the study drug was evaluated based on its ability in increasing the time to additional interventions at the treated level over 24 months post-treatment. Kaplan-Meier estimates for the probability (expressed as a percentage) of participants to receive an intervention are presented.'}, {'measure': 'Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate', 'timeFrame': 'Month 24', 'description': "A minimal disability responder was defined as a participant who achieved an ODI score of 20% or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Lumbar Back Pain', 'Low back pain', 'Back pain', 'Degenerative Disc Disease', 'Injection of Degenerated Lumbar Disc', 'Intervertebral Disc Degeneration', 'Bone Diseases', 'Musculoskeletal Diseases', 'Nervous System Diseases', 'Neurologic Manifestations', 'Pain', 'Spinal Diseases', 'Stem Cells', 'Adult Stem Cells', 'Allogeneic Mesenchymal Precursor cells (MPCs)', 'Mesoblast', 'Hyaluronic Acid', 'Pharmaceutical Solutions', 'Adjuvants, Immunologic', 'Immunologic Factors', 'Pharmacologic Actions', 'Protective Agents', 'rexlemestrocel-L', 'Viscosupplements'], 'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': "This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (\\> 6 months) associated with moderate radiographic degenerative changes of a disc."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female participants 18 years of age and older\n* If female of childbearing potential, participant is non-pregnant, non-nursing, and agrees to use highly effective methods of contraception for a minimum of 24 months post-treatment\n* Signed informed consent and country-appropriate privacy forms indicating participant is willing to undergo treatment and willing to be available for each examination scheduled over the study duration\n* Have documented diagnosis of moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a disc suspected of causing chronic low back pain (CLBP) associated with moderate radiographic degeneration at a lumbar disc is defined as the following (participant must meet all of the listed conditions):\n\n 1. Chronic low back pain for at least 6 months\n 2. Have failed 6 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest, medications \\[e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants\\], massage, acupuncture, chiropractic manipulations, activity modification, home-directed lumbar exercise program, and non-invasive pain control treatments or procedures)\n 3. Have at a minimum undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain and taken a pain medication for back pain (e.g. non-steroidal anti-inflammatory drug (NSAID) and/or opioid medication).\n 4. Change from normal disc morphology of the index disc as defined by radiographic evaluation by the core imaging evaluation provider. Radiographs must show all of the following:\n* A modified Pfirrmann score of 3, 4, 5 or 6 on magnetic resonance imaging (MRI) at the index disc\n* Modic Grade II changes or less on MRI at the index disc\n* With or without contained disc protrusion at the index disc on MRI\n\n e. Low back pain of at least 40mm and not more than 90mm of 100mm on low back pain visual analogue scale (VAS) (average pain over 24 hours)\n\n f. Leg pain ≤20mm in both legs on a 100mm VAS scale\n\n g. Oswestry disability index (ODI) score of at least 30 and no more than 90 on a 100 point scale.\n\nExclusion Criteria:\n\n* Female participants who are pregnant or nursing, or women planning to become pregnant in the first 24 months post-treatment\n* Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI \\> 40)\n* Have undergone a surgical procedure (e.g. discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion) on the disc at the index or adjacent level\n* Osteoporosis, as defined by dual-energy X-ray absorptiometry (DEXA) scan. A DEXA T-score of ≤ -2.5 will exclude the participant.\n* Any lumbar intradiscal injection, including steroids, into the index or adjacent discs prior to treatment injection, with the exception of the following injections performed at least 2 weeks prior to study treatment:\n\n 1. Contrast medium (discography or other diagnostic injection)\n 2. NSAIDs\n 3. Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)\n 4. Antibiotics\n 5. Saline\n* Have undergone a procedure affecting the structure/biomechanics of the index disc level (e.g., posterolateral fusion)\n* Active malignancy or tumor as source of symptoms or history of malignancy within the 5 years prior to enrolment on study\n* Have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the index intervertebral disc\n* An average baseline morphine equivalent dose (MED) of \\>75mg/day as determined by e-diary entries during the screening period\n* Taking systemic immunosuppressants\n* A medical condition, serious intercurrent illness, or extenuating circumstance that would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation.\n* Participants involved in spinal litigation, including workman's compensation, unless litigation is complete\n* Are transient or has a severe alcohol or substance abuse problem\n* Clinically significant nerve pain (e.g., chronic radiculopathy or neuropathy)\n* Clinically significant sacroiliac joint pain\n* Compressive pathology due to stenosis or disc protrusion on MRI with associated clinical symptoms defined as leg pain VAS\\>20mm out of 100mm or neurologic deficit on neurologic exam\n* Disc extrusion with a maximum dimension greater or equal to twice the posterior height of the disc, or disc sequestration in the lumbar spine on MRI as determined by radiographic core lab\n* Modified Pfirrmann score of 7 or 8 at any lumbar level (L1-S1) on MRI evaluation as determined by radiographic core lab\n* Symptomatic involvement of more than one lumbar disc\n* Symptomatic central vertebral canal stenosis as defined by neurogenic claudication\n* Spondylolisthesis or retrolisthesis Grade 2 and above or Spondylolysis at the index or adjacent level(s)\n* Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc\n* Spinal deformity defined as lumbar scoliosis with a Cobb angle of the lumbar spine greater than 15 degrees\n* Any fracture of the spine at the index or adjacent levels that has not healed, or clinically compromised vertebral bodies at the index level due to current or past trauma\n* Facet pain at the index level or adjacent segments as determined by a diagnostic medial branch block (a facet block injection is not acceptable for making this determination) to rule out facet joint involvement.\n* Full thickness annular tears in the index level as determined by free flowing contrast media through the annulus fibrosis."}, 'identificationModule': {'nctId': 'NCT02412735', 'acronym': 'MSB-DR003', 'briefTitle': 'Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mesoblast, Ltd.'}, 'officialTitle': 'A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'MSB-DR003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rexlemestrocel-L', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).', 'interventionNames': ['Drug: Rexlemestrocel-L']}, {'type': 'EXPERIMENTAL', 'label': 'Rexlemestrocel-L + HA', 'description': 'Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0 (Visit 2).', 'interventionNames': ['Drug: Rexlemestrocel-L + HA Mixture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received saline solution as matching-placebo on Day 0 (Visit 2).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rexlemestrocel-L', 'type': 'DRUG', 'description': 'Rexlemestrocel-L injection', 'armGroupLabels': ['Rexlemestrocel-L']}, {'name': 'Rexlemestrocel-L + HA Mixture', 'type': 'DRUG', 'description': 'Rexlemestrocel-L was combined in 1:1 by-volume ratio with HA solution and the resulting mixture was injected', 'armGroupLabels': ['Rexlemestrocel-L + HA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline control solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Tennessee Valley Pain Consultants', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Pain Specialists', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85284-2604', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Physicians Research Group', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '92020-4124', 'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'facility': 'TriWest Research Associates, LLC', 'geoPoint': {'lat': 32.79477, 'lon': -116.96253}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Orthopaedics Surgical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Newport Beach Headache and Pain', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Institute for Regenerative Medicine and Clinical Research', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Spine Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Orthopedic Pain Specialists', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'The Spine Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '95401', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Summit Pain Alliance', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Integrated Pain Management', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Back Pain Specialists, LLC', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32034', 'city': 'Fernandina Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Clinical Research Specialists', 'geoPoint': {'lat': 30.66968, 'lon': -81.46259}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Shrock Orthopedic Research, LLC', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33334', 'city': 'Oakland Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Orthopedics Institute', 'geoPoint': {'lat': 26.17231, 'lon': -80.13199}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Orthopaedics & Spine Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Institute for Clinical Research, LLC', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '83713', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Injury Care Medical Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Millennium Pain Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Otrimed Clinical Research', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Orthopedic Specialists of Louisiana', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55379', 'city': 'Shakopee', 'state': 'Minnesota', 'country': 'United States', 'facility': 'MAPS Applied Research Center', 'geoPoint': {'lat': 44.79802, 'lon': -93.5269}}, {'zip': '89129', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Innovative Pain Care Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08873', 'city': 'Somerset', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Clinical Research', 'geoPoint': {'lat': 40.4976, 'lon': -74.48849}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Ainsworth Institute of Pain Management', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14626', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Regional Health', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Neurosurgery and Spine Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28117', 'city': 'Morrisville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'On Site Clinical Solutions, LLC', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research/ Carolinas Pain Institute', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45432', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'DOC Clinical Research', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '73013', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Clinical Investigations, LLC', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '17402', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Orthopaedic and Spine Specialists', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'RI Hospital-Comprehensive Spine Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Trials of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Pharmaceutical Research, Inc.', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Back Institute', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '76092', 'city': 'Southlake', 'state': 'Texas', 'country': 'United States', 'facility': 'Spine Team Texas', 'geoPoint': {'lat': 32.94124, 'lon': -97.13418}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Spine Care', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', 'country': 'United States', 'facility': 'Ericksen Research & Development, LLC', 'geoPoint': {'lat': 40.88939, 'lon': -111.88077}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'the SMART Clinic', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '84790', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Hope Research Institute', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia iSpine Physicians, PC', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Center', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}], 'overallOfficials': [{'name': 'Roger Brown', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mesoblast, Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mesoblast, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}