Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04445220
Status:
UNKNOWN
Last Update Posted:
2022-01-14
First Post:
2020-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D018805', 'term': 'Sepsis'}], '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'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as measured by incidence of IP-related serious adverse events', 'timeFrame': 'Outcomes and Serious Adverse Events through Day 180'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CRRT', 'AKI', 'Continuous renal replacement therapy', 'MSC', 'Mesenchymal stromal cells', 'Mesenchymal stem cells', 'Stem cells', 'Cell therapy'], 'conditions': ['COVID-19', 'Acute Kidney Injury', 'Sepsis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented evidence of infection, e.g., positive PCR for COVID-19, positive blood cultures for systemic infection, active urinary sediment to suggest UTI, or any imaging supportive of a clinical diagnosis of infection, for example, pulmonary infiltrate on chest x-ray to suggest pneumonia, pancreatitis on CT imaging, abdominal collection, etc.\n* AKI as determined by the Investigator based on his/her clinical judgment\n* Receiving or planned to receive RRT in \\< 24 hours\n* Able to tolerate indwelling intravascular access\n* Has tolerated CRRT for at least 6 hours prior to IP treatment\n* Have maintained hemodynamic stability for at least 6 hours prior to IP treatment with only minor changes in pressure support medication required (if used)\n* Vascular access (catheter placement) is patent and capable of supporting CRRT for the duration of IP treatment\n* Likely to require RRT for at least an additional 48 hours\n* Potassium level \\>3.6 and \\<5.5 mEq/L or \\>3.6 and \\< 5.5 mmol/L prior to IP treatment\n* SaO2 \\> 92% prior to IP initiation\n* Blood pH \\> 7.2 prior to IP initiation\n* Medically cleared to receive anticoagulation per institutional standard of care / PI prescribed protocol and meeting protocol defined anticoagulation targets prior to receipt of IP\n* Ability to give informed consent or have a legally authorized representative do so\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, planning to become pregnant, or lactating\n* MAP \\<70 mmHg immediately prior to IP initiation\n* Systolic blood pressure \\< 90 mmHg immediately prior to IP initiation\n* Mechanical ventilator support requiring FiO2 \\> 80% prior to IP initiation\n* Receiving extracorporeal membrane oxygenation (ECMO)\n* Liver disease with Child Pugh score of \\> 7 prior to IP initiation\n* High sensitivity cardiac Troponin level (hs-cTn) \\> 100.0 ng/L prior to IP initiation or other equivalent Troponin test result prior to IP initiation\n* Hepatorenal syndrome\n* AKI due to post-renal outflow obstruction\n* Acute or chronic vasculitis of any etiology\n* Chronic systemic infection\n* Subjects with a past medical history of an inherited or acquired hypercoagulable condition independent of COVID-19\n* Patients with a past medical history of an allergic response to MSC therapy\n* Participation in another interventional trial with the exception of studies of antivirals, corticosteroids, hydroxychloroquine, azithromycin, or angiotensin converting enzyme inhibitors/angiotensin receptor blockers (or related compounds)\n* Active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with the exception of non-melanoma skin cancer\n* Subjects, who in the opinion of the Investigator, are likely to require escalating doses of vasopressors to attain and/or maintain hemodynamic stability, or subjects who have reached the institutionally defined maximum level of vasopressor support within 12 hours of intended IP integration\n* Imminent death in \\<24 hours\n* Organ failure affecting more than 2 non-renal organs\n* Platelet count \\<50,000/μL or other serious hematological abnormalities that would place subject in imminent danger of death\n* Lactate levels \\>8 mmol/L suggestive of severe end-organ hypoperfusion prior to the time of IP integration\n* Any prior medical condition or recent surgical procedure, planned significant medical interventions or procedures that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements'}, 'identificationModule': {'nctId': 'NCT04445220', 'briefTitle': 'A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sentien Biotechnologies, Inc.'}, 'officialTitle': 'A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy', 'orgStudyIdInfo': {'id': 'SBI-101-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose cohort', 'description': 'SBI-101 device containing 250 million MSCs', 'interventionNames': ['Biological: SBI-101']}, {'type': 'EXPERIMENTAL', 'label': 'High dose cohort', 'description': 'SBI-101 device containing 750 million MSCs', 'interventionNames': ['Biological: SBI-101']}, {'type': 'NO_INTERVENTION', 'label': 'Case controls', 'description': 'Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants.'}], 'interventions': [{'name': 'SBI-101', 'type': 'BIOLOGICAL', 'description': 'SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.', 'armGroupLabels': ['High dose cohort', 'Low dose cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico School of Medicine', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sentien Biotechnologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}