Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 5:41 PM
Study NCT ID:
NCT04377334
Status:
UNKNOWN
Last Update Posted:
2022-01-27
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
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': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung injury score', 'timeFrame': 'day 10', 'description': 'improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points'}], 'secondaryOutcomes': [{'measure': 'D-dimers', 'timeFrame': 'day 0, 1, 2, 3, 10 and 15', 'description': 'D-dimers blood levels'}, {'measure': 'phenotype', 'timeFrame': 'day 0, 1, 2, 3, 10 and 15', 'description': 'distribution of phenotypes of immune cells'}, {'measure': 'pro-resolving lipid mediators', 'timeFrame': 'day 0, 1, 2, 3, 10 and 15', 'description': 'Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage'}, {'measure': 'cytokines', 'timeFrame': 'day 0, 1, 2, 3, 10 and 15', 'description': 'Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions'}, {'measure': 'chemokines', 'timeFrame': 'day 0, 1, 2, 3, 10 and 15', 'description': 'Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions'}, {'measure': 'Survival', 'timeFrame': 'day 10 and 28', 'description': 'Survival at 10 days and 28 days'}, {'measure': 'extubation', 'timeFrame': 'day 28', 'description': 'Time to removal of endotracheal tube'}, {'measure': 'lymphocyte subpopulations', 'timeFrame': 'day 0, 3, 5 and 10', 'description': 'lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)'}, {'measure': 'SARS-CoV-2-specific antibody titers', 'timeFrame': 'day 0, 5 and 10', 'description': 'evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.'}, {'measure': 'complement molecules (C5-C9)', 'timeFrame': 'day 0, 5 and 10', 'description': 'evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* COVID-19-positive subject\n* Horowitz index ≤ 200\n* Bilateral opacities on frontal chest radiograph, and\n* requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation\n* no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.\n* Subject's Age ≥ 18 years\n\nExclusion Criteria:\n\n* COVID-19-negative subject\n* Subject's Age \\< 18 years\n* More than 7 days since initiation of mechanical ventilation\n* Patient, surrogate or physician not committed to full intensive care support.\n* Positive Pregnancy test at the time of screening.\n* Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug"}, 'identificationModule': {'nctId': 'NCT04377334', 'briefTitle': 'Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS', 'orgStudyIdInfo': {'id': 'RESCOVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSC Treatment', 'interventionNames': ['Biological: MSC']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'MSC', 'type': 'BIOLOGICAL', 'description': 'infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells', 'armGroupLabels': ['MSC Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'contacts': [{'name': 'Peter Rosenberger, MD', 'role': 'CONTACT'}, {'name': 'Peter Rosenberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Peter Rosenberger, Prof.', 'role': 'CONTACT', 'email': 'peter.rosenberger@med.uni-tuebingen.de', 'phone': '+49707129', 'phoneExt': '86622'}], 'overallOfficials': [{'name': 'Peter Rosenberger, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tübingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}