Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-30 @ 12:18 AM
Study NCT ID:
NCT04909892
Status:
WITHDRAWN
Last Update Posted:
2021-09-16
First Post:
2021-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': 'D018352', 'term': 'Coronavirus Infections'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Replaced by a different protocol.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-05-29', 'studyFirstSubmitQcDate': '2021-05-29', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 6-Minute Walk Distance (6MWD) at Day 60', 'timeFrame': 'Baseline to Day 60', 'description': 'Change in 6MWD at Day 60'}], 'secondaryOutcomes': [{'measure': 'Change in 6MWD at Day 30', 'timeFrame': 'Baseline to Day 30', 'description': 'Change in 6MWD at Day 30'}, {'measure': 'Change in Pulmonary Function Tests (PFTs)', 'timeFrame': 'Baseline to Day 30 and Day 60', 'description': 'Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO)'}, {'measure': 'Change in oxygenation', 'timeFrame': 'Baseline to Day 30 and Day 60', 'description': 'Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio'}, {'measure': 'Change in biomarker levels', 'timeFrame': 'Baseline through Day 30', 'description': 'Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'long haul', 'post-acute covid'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.', 'detailedDescription': 'This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.\n\nCOVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen\n* Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)\n* Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status\n* Willing to follow contraception guidelines\n\nExclusion Criteria:\n\n* Clinically improving pulmonary status over the month prior to screening\n* Undergone a previous stem cell infusion unrelated to this trial\n* Pregnant or breast feeding or planning for either during the study\n* Suspected uncontrolled active bacterial, fungal, viral, or other infection\n* History of a splenectomy, lung transplant or lung lobectomy\n* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)'}, 'identificationModule': {'nctId': 'NCT04909892', 'briefTitle': 'Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sorrento Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise', 'orgStudyIdInfo': {'id': 'MSC-PLH-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVI-MSC 1 vial', 'description': 'Subjects will receive intravenous infusions of COVI-MSC (one vial, \\~18.5 million cells) on Day 0, Day 2, and Day 4.', 'interventionNames': ['Biological: COVI-MSC']}, {'type': 'EXPERIMENTAL', 'label': 'COVI-MSC 2 vials', 'description': 'Subjects will receive intravenous infusions of COVI-MSC (two vials, \\~37 million cells) on Day 0, Day 2, and Day 4.', 'interventionNames': ['Biological: COVI-MSC']}], 'interventions': [{'name': 'COVI-MSC', 'type': 'BIOLOGICAL', 'description': 'COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells', 'armGroupLabels': ['COVI-MSC 1 vial', 'COVI-MSC 2 vials']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mike Royal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sorrento Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorrento Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}