Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04348435
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2020-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ridhima@hopebio.org', 'phone': '346-900-0340', 'title': 'Ridhima Vij, PhD', 'phoneExt': '102', 'organization': 'Hope Biosciences Stem Cell Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Out of 53 total subjects, 37 subjects had reported at least one adverse event (AE). A total of 139 AEs were recorded during the entire course of study, out of which 135 were mild in severity, 4 were moderate and none was severe. There were no serious adverse events (SAEs) reported during the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 15, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Muscle fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Salivary hyper-secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corona virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rotator cuff repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Were Hospitalized Due to COVID-19 Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'Number of Subjects that were Hospitalized due to COVID-19 Symptoms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Number of Subjects that were not Hospitalized due to COVID-19 Symptoms', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 37 subjects completed all 5 infusions.'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Had Symptoms Associated With COVID-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'Number of Subjects with Incidence of COVID-19 Symptoms', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Number of Subjects with No Incidence of COVID-19 Symptoms', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 37 subjects who completed all 5 infusions.'}, {'type': 'SECONDARY', 'title': 'Leukocyte Differential Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'LSMeans', 'categories': [{'measurements': [{'value': '6.204', 'spread': '0.296', 'groupId': 'OG000'}, {'value': '5.518', 'spread': '0.502', 'groupId': 'OG001'}, {'value': '6.029', 'spread': '0.393', 'groupId': 'OG002'}, {'value': '5.951', 'spread': '0.392', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.508', 'spread': '0.296', 'groupId': 'OG000'}, {'value': '-0.179', 'spread': '0.502', 'groupId': 'OG001'}, {'value': '0.333', 'spread': '0.393', 'groupId': 'OG002'}, {'value': '0.255', 'spread': '0.392', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6113', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.253', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.490', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5039', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.434', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.638', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8903', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.077', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.555', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 to Week 26 (End of Study)', 'description': 'Change from baseline in Leukocyte Differential Count', 'unitOfMeasure': 'Leukocytes (x10^9/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects contributing to analysis.'}, {'type': 'SECONDARY', 'title': 'C Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'LSMeans', 'categories': [{'measurements': [{'value': '2.424', 'spread': '0.632', 'groupId': 'OG000'}, {'value': '1.759', 'spread': '1.047', 'groupId': 'OG001'}, {'value': '2.679', 'spread': '0.846', 'groupId': 'OG002'}, {'value': '2.671', 'spread': '0.843', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.609', 'spread': '0.632', 'groupId': 'OG000'}, {'value': '-1.275', 'spread': '1.047', 'groupId': 'OG001'}, {'value': '-0.354', 'spread': '0.846', 'groupId': 'OG002'}, {'value': '-0.362', 'spread': '0.843', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8171', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.247', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.056', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5034', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.913', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.342', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9948', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.008', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.193', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Change from baseline in C Reactive Protein', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects contributing to analysis.'}, {'type': 'SECONDARY', 'title': 'Tumor Necrosis Factor - Alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'LSMeans', 'categories': [{'measurements': [{'value': '1.175', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '0.951', 'spread': '0.150', 'groupId': 'OG001'}, {'value': '1.173', 'spread': '0.123', 'groupId': 'OG002'}, {'value': '0.996', 'spread': '0.124', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.316', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '-0.540', 'spread': '0.150', 'groupId': 'OG001'}, {'value': '-0.318', 'spread': '0.123', 'groupId': 'OG002'}, {'value': '-0.495', 'spread': '0.124', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2641', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.179', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.156', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8220', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.045', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.198', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3097', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.171', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Change from baseline in TNF alpha', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects contributing to analysis.'}, {'type': 'SECONDARY', 'title': 'Interleukin 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'LSMeans', 'categories': [{'measurements': [{'value': '1.620', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '1.620', 'spread': '0.065', 'groupId': 'OG001'}, {'value': '1.732', 'spread': '0.053', 'groupId': 'OG002'}, {'value': '1.620', 'spread': '0.056', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '-0.019', 'spread': '0.065', 'groupId': 'OG001'}, {'value': '0.092', 'spread': '0.053', 'groupId': 'OG002'}, {'value': '-0.019', 'spread': '0.056', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.000', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.070', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.000', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.087', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1713', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.112', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.079', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Change from baseline in IL-6', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects contributing to analysis.'}, {'type': 'SECONDARY', 'title': 'Interleukin 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'LSMeans', 'categories': [{'measurements': [{'value': '0.768', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.680', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '0.680', 'spread': '0.073', 'groupId': 'OG002'}, {'value': '0.688', 'spread': '0.073', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.088', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.073', 'groupId': 'OG002'}, {'value': '0.008', 'spread': '0.073', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3868', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.080', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.091', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9429', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.115', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9362', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.103', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Change from baseline in IL-10', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects contributing to analysis.'}, {'type': 'SECONDARY', 'title': 'Short Form-36 (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'Average Energy/Fatigue', 'categories': [{'measurements': [{'value': '68.858', 'spread': '5.139', 'groupId': 'OG000'}, {'value': '78.346', 'spread': '7.672', 'groupId': 'OG001'}, {'value': '75.849', 'spread': '5.125', 'groupId': 'OG002'}, {'value': '69.567', 'spread': '5.826', 'groupId': 'OG003'}]}]}, {'title': 'Average Energy/Fatigue - Change from baseline', 'categories': [{'measurements': [{'value': '7.140', 'spread': '5.139', 'groupId': 'OG000'}, {'value': '16.628', 'spread': '7.672', 'groupId': 'OG001'}, {'value': '14.130', 'spread': '5.125', 'groupId': 'OG002'}, {'value': '7.848', 'spread': '5.826', 'groupId': 'OG003'}]}]}, {'title': 'Average Social Functioning', 'categories': [{'measurements': [{'value': '98.950', 'spread': '2.190', 'groupId': 'OG000'}, {'value': '90.711', 'spread': '3.556', 'groupId': 'OG001'}, {'value': '99.864', 'spread': '2.503', 'groupId': 'OG002'}, {'value': '98.430', 'spread': '2.484', 'groupId': 'OG003'}]}]}, {'title': 'Average Social Functioning - Change from baseline', 'categories': [{'measurements': [{'value': '7.153', 'spread': '2.190', 'groupId': 'OG000'}, {'value': '-1.086', 'spread': '3.556', 'groupId': 'OG001'}, {'value': '8.067', 'spread': '2.503', 'groupId': 'OG002'}, {'value': '6.633', 'spread': '2.484', 'groupId': 'OG003'}]}]}, {'title': 'Avg. Role Limitations Due to Physical Health', 'categories': [{'measurements': [{'value': '94.711', 'spread': '2.326', 'groupId': 'OG000'}, {'value': '100.00', 'spread': '4.393', 'groupId': 'OG001'}, {'value': '98.727', 'spread': '2.587', 'groupId': 'OG002'}, {'value': '98.831', 'spread': '2.737', 'groupId': 'OG003'}]}]}, {'title': 'Avg. Role Limitations Due to Physical Health - Change from baseline', 'categories': [{'measurements': [{'value': '1.742', 'spread': '2.326', 'groupId': 'OG000'}, {'value': '14.280', 'spread': '4.393', 'groupId': 'OG001'}, {'value': '5.758', 'spread': '2.587', 'groupId': 'OG002'}, {'value': '5.862', 'spread': '2.737', 'groupId': 'OG003'}]}]}, {'title': 'Average General Health', 'categories': [{'measurements': [{'value': '76.481', 'spread': '3.818', 'groupId': 'OG000'}, {'value': '78.857', 'spread': '6.274', 'groupId': 'OG001'}, {'value': '81.016', 'spread': '4.196', 'groupId': 'OG002'}, {'value': '75.518', 'spread': '4.454', 'groupId': 'OG003'}]}]}, {'title': 'Average General Health - Change from baseline', 'categories': [{'measurements': [{'value': '1.481', 'spread': '3.818', 'groupId': 'OG000'}, {'value': '3.857', 'spread': '6.274', 'groupId': 'OG001'}, {'value': '6.016', 'spread': '4.196', 'groupId': 'OG002'}, {'value': '0.518', 'spread': '4.454', 'groupId': 'OG003'}]}]}, {'title': 'Average Physical Functioning', 'categories': [{'measurements': [{'value': '92.361', 'spread': '2.660', 'groupId': 'OG000'}, {'value': '96.806', 'spread': '4.420', 'groupId': 'OG001'}, {'value': '93.598', 'spread': '2.939', 'groupId': 'OG002'}, {'value': '89.928', 'spread': '3.123', 'groupId': 'OG003'}]}]}, {'title': 'Average Physical Functioning - Change from baseline', 'categories': [{'measurements': [{'value': '1.267', 'spread': '2.660', 'groupId': 'OG000'}, {'value': '5.712', 'spread': '4.420', 'groupId': 'OG001'}, {'value': '2.504', 'spread': '2.939', 'groupId': 'OG002'}, {'value': '-1.166', 'spread': '3.123', 'groupId': 'OG003'}]}]}, {'title': 'Average Pain', 'categories': [{'measurements': [{'value': '90.744', 'spread': '3.746', 'groupId': 'OG000'}, {'value': '84.700', 'spread': '6.291', 'groupId': 'OG001'}, {'value': '91.166', 'spread': '4.124', 'groupId': 'OG002'}, {'value': '79.065', 'spread': '4.377', 'groupId': 'OG003'}]}]}, {'title': 'Average Pain - Change from baseline', 'categories': [{'measurements': [{'value': '11.212', 'spread': '3.746', 'groupId': 'OG000'}, {'value': '5.169', 'spread': '6.291', 'groupId': 'OG001'}, {'value': '11.635', 'spread': '4.124', 'groupId': 'OG002'}, {'value': '-0.466', 'spread': '4.377', 'groupId': 'OG003'}]}]}, {'title': 'Average Emotional Well Being', 'categories': [{'measurements': [{'value': '87.057', 'spread': '2.566', 'groupId': 'OG000'}, {'value': '88.413', 'spread': '4.096', 'groupId': 'OG001'}, {'value': '86.992', 'spread': '2.739', 'groupId': 'OG002'}, {'value': '84.724', 'spread': '2.863', 'groupId': 'OG003'}]}]}, {'title': 'Average Emotional Well Being - Change from baseline', 'categories': [{'measurements': [{'value': '4.057', 'spread': '2.566', 'groupId': 'OG000'}, {'value': '5.413', 'spread': '4.096', 'groupId': 'OG001'}, {'value': '3.992', 'spread': '2.739', 'groupId': 'OG002'}, {'value': '1.724', 'spread': '2.863', 'groupId': 'OG003'}]}]}, {'title': 'Avg. Role Limitations Due to Emotional Problems', 'categories': [{'measurements': [{'value': '99.667', 'spread': '2.334', 'groupId': 'OG000'}, {'value': '97.000', 'spread': '3.654', 'groupId': 'OG001'}, {'value': '97.000', 'spread': '2.456', 'groupId': 'OG002'}, {'value': '97.000', 'spread': '2.601', 'groupId': 'OG003'}]}]}, {'title': 'Avg. Role Limitations Due to Emotional Problems - Change from baseline', 'categories': [{'measurements': [{'value': '3.833', 'spread': '2.334', 'groupId': 'OG000'}, {'value': '1.166', 'spread': '3.654', 'groupId': 'OG001'}, {'value': '1.166', 'spread': '2.456', 'groupId': 'OG002'}, {'value': '1.166', 'spread': '2.601', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9333', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.708', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.380', 'groupDescription': 'Average Energy/Fatigue - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3627', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.780', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.483', 'groupDescription': 'Average Energy/Fatigue - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4160', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.282', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.604', 'groupDescription': 'Average Energy/Fatigue - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8768', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.520', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.320', 'groupDescription': 'Average Social Functioning - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0869', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.719', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.344', 'groupDescription': 'Average Social Functioning - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6864', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.434', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.514', 'groupDescription': 'Average Social Functioning - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2587', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.120', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.571', 'groupDescription': 'Avg. Role Limitations Due to Physical Health - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1250', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.417', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.316', 'groupDescription': 'Avg. Role Limitations Due to Physical Health - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9780', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.104', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.732', 'groupDescription': 'Avg. Role Limitations Due to Physical Health - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8721', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.963', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.925', 'groupDescription': 'Average General Health - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6694', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.340', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.735', 'groupDescription': 'Average General Health - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3733', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.498', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.073', 'groupDescription': 'Average General Health - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5594', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.433', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.116', 'groupDescription': 'Average Physical Functioning - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2127', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.878', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.389', 'groupDescription': 'Average Physical Functioning - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4012', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.670', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.303', 'groupDescription': 'Average Physical Functioning - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0521', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.678', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.748', 'groupDescription': 'Average Pain - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4704', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.635', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.696', 'groupDescription': 'Average Pain - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0544', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.101', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.017', 'groupDescription': 'Average Pain - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5535', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.333', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.888', 'groupDescription': 'Average Emotional Well Being - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4642', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.689', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.969', 'groupDescription': 'Average Emotional Well Being - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5692', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.268', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.936', 'groupDescription': 'Average Emotional Well Being - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4642', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.667', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.592', 'groupDescription': 'Avg. Role Limitations Due to Emotional Problems - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.000', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.444', 'groupDescription': 'Avg. Role Limitations Due to Emotional Problems - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.000', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.526', 'groupDescription': 'Avg. Role Limitations Due to Emotional Problems - Treatment Contrast', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 to Week 26 (End of Study)', 'description': 'The Short Form-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores (including Energy/Fatigue scores, Social Functioning, role limitations due to Physical Health, General Health, Physical Functioning, Pain, Emotional Well-Being, and Emotional Problems) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects contributing to analysis.'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire (PHQ-9) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'classes': [{'title': 'LSMeans', 'categories': [{'measurements': [{'value': '1.373', 'spread': '0.489', 'groupId': 'OG000'}, {'value': '0.912', 'spread': '0.763', 'groupId': 'OG001'}, {'value': '1.114', 'spread': '0.456', 'groupId': 'OG002'}, {'value': '1.517', 'spread': '0.538', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-1.111', 'spread': '0.489', 'groupId': 'OG000'}, {'value': '-1.572', 'spread': '0.763', 'groupId': 'OG001'}, {'value': '-1.370', 'spread': '0.456', 'groupId': 'OG002'}, {'value': '-0.967', 'spread': '0.538', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8628', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.144', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.825', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5257', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.605', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.940', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5467', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.403', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.659', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 to Week 26 (End of Study)', 'description': 'The study used PHQ-9 as a depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day) to monitor the severity of depression.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects contributing to analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'FG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'FG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline).\n\nPlacebos: Saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Selection of subjects was based on the inclusion and exclusion criteria and only those subjects who met all of the inclusion criteria and none of the exclusion criteria, were eligible to participate in the trial. The first participant was enrolled on 05/14/2020 and the last participant was enrolled on 11/04/2020.', 'preAssignmentDetails': 'A total of 84 subjects were assessed for screening, out of which only 53 were enrolled and 31 were screen failed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'BG001', 'title': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'BG002', 'title': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.\n\nHB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14.\n\nPlacebos: Saline'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '13.34', 'groupId': 'BG000'}, {'value': '47.6', 'spread': '9.65', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '12.38', 'groupId': 'BG002'}, {'value': '42.8', 'spread': '9.97', 'groupId': 'BG003'}, {'value': '44.9', 'spread': '11.58', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '172.05', 'spread': '10.18', 'groupId': 'BG000'}, {'value': '167.35', 'spread': '11.60', 'groupId': 'BG001'}, {'value': '168.38', 'spread': '8.70', 'groupId': 'BG002'}, {'value': '171.54', 'spread': '11.66', 'groupId': 'BG003'}, {'value': '170.30', 'spread': '10.39', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '93.132', 'spread': '29.12', 'groupId': 'BG000'}, {'value': '85.982', 'spread': '26.72', 'groupId': 'BG001'}, {'value': '78.662', 'spread': '14.69', 'groupId': 'BG002'}, {'value': '79.763', 'spread': '23.51', 'groupId': 'BG003'}, {'value': '85.362', 'spread': '24.84', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '31.14', 'spread': '8.426', 'groupId': 'BG000'}, {'value': '30.18', 'spread': '6.271', 'groupId': 'BG001'}, {'value': '27.61', 'spread': '3.946', 'groupId': 'BG002'}, {'value': '26.83', 'spread': '6.606', 'groupId': 'BG003'}, {'value': '29.12', 'spread': '6.893', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-29', 'size': 555825, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-09T17:44', 'hasProtocol': True}, {'date': '2021-10-14', 'size': 292135, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-12T17:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2020-04-14', 'resultsFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-10-26', 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Were Hospitalized Due to COVID-19 Symptoms', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study.'}, {'measure': 'Number of Participants That Had Symptoms Associated With COVID-19', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc.'}], 'secondaryOutcomes': [{'measure': 'Leukocyte Differential Count', 'timeFrame': 'Week 0 to Week 26 (End of Study)', 'description': 'Change from baseline in Leukocyte Differential Count'}, {'measure': 'C Reactive Protein', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Change from baseline in C Reactive Protein'}, {'measure': 'Tumor Necrosis Factor - Alpha', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Change from baseline in TNF alpha'}, {'measure': 'Interleukin 6', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Change from baseline in IL-6'}, {'measure': 'Interleukin 10', 'timeFrame': 'Week 0 through Week 26 (End of Study)', 'description': 'Change from baseline in IL-10'}, {'measure': 'Short Form-36 (SF-36)', 'timeFrame': 'Week 0 to Week 26 (End of Study)', 'description': 'The Short Form-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores (including Energy/Fatigue scores, Social Functioning, role limitations due to Physical Health, General Health, Physical Functioning, Pain, Emotional Well-Being, and Emotional Problems) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.'}, {'measure': 'Patient Health Questionnaire (PHQ-9) Scores', 'timeFrame': 'Week 0 to Week 26 (End of Study)', 'description': 'The study used PHQ-9 as a depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day) to monitor the severity of depression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus', 'Prevention', 'Immune support', 'stem cells', 'mesenchymal stem cells', 'adipose-derived mesenchymal stem cells'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.', 'detailedDescription': 'This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 100 patients will be enrolled. Eligible participants are at high or very high exposure risk of contracting COVID-19. The primary endpoint of this study is to provide immune support against COVID-19, measured by the percentage of subjects that develop symptoms of COVID-19. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men, and women 18 years of age or older\n* Participant works in a capacity that is characterized as high-risk or very high-risk\n* High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19.\n* First responders, health care delivery and support staff (e.g., law enforcement, fire fighters, paramedics, doctors, nurses, and other hospital staff who must enter patients' rooms) exposed to individuals potentially having COVID-19.\n* Mortuary workers involved in preparing (e.g., for burial or cremation) the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death\n* Very High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19 during specific medical, postmortem or laboratory procedures.\n* Health care workers (e.g., doctors, nurses, dentists, paramedics, emergency medical technicians) performing aerosol-generating procedures (e.g., intubation, cough induction procedures, bronchoscopies, some dental procedures and exams or invasive specimen collection) on known or suspected COVID-19 patients.\n* Health care or laboratory personnel collecting or handling specimens from known or suspected COVID-19 patients (e.g., manipulating cultures from known or suspected COVID-19 patients).\n* Morgue workers performing autopsies, which generally involve aerosol-generating procedures, on the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death\n* No signs or symptoms of infection, including but not limited to, body temperature \\>100 F and pulse rate \\> 100 BPM.\n* Subject provides written informed consent prior to initiation of any study procedures.--Agrees to the collection of venous blood per protocol.\n* Agrees to conformational testing for SARS-CoV-2 before end of study.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating, or those who are not pregnant but do not take effective contraceptive measures\n* Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days;\n* Inability to provide informed consent or to comply with test requirements;\n* Any medical disease or condition that, in the opinion of the site PI or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.\n* Patients who have received a stem cell treatment within one year.\n* Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study."}, 'identificationModule': {'nctId': 'NCT04348435', 'briefTitle': 'A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hope Biosciences Research Foundation'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Assess Efficacy and Safety of Allogeneic HB-adMSCs to Provide Immune Support Against COVID-19.', 'orgStudyIdInfo': {'id': 'HBCOV02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allogeneic HB-adMSCs 200MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.', 'interventionNames': ['Biological: HB-adMSCs']}, {'type': 'EXPERIMENTAL', 'label': 'Allogeneic HB-adMSCs 100MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.', 'interventionNames': ['Biological: HB-adMSCs']}, {'type': 'EXPERIMENTAL', 'label': 'Allogeneic HB-adMSCs 50MM', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.', 'interventionNames': ['Biological: HB-adMSCs']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14.', 'interventionNames': ['Other: Placebos']}], 'interventions': [{'name': 'HB-adMSCs', 'type': 'BIOLOGICAL', 'description': 'Hope Biosciences allogeneic adipose-derived mesenchymal stem cells', 'armGroupLabels': ['Allogeneic HB-adMSCs 100MM', 'Allogeneic HB-adMSCs 200MM', 'Allogeneic HB-adMSCs 50MM']}, {'name': 'Placebos', 'type': 'OTHER', 'description': 'Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Hope Biosciences Stem Cell Research Foundation', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}], 'overallOfficials': [{'name': 'Thanh Cheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hope Biosciences Stem Cell Research Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hope Biosciences Research Foundation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}