[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440592":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":37,"responsibleParty":39,"collaborators":37,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":37,"enrollmentInfo":51,"targetDuration":37,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":37,"overallStatus":61,"whyStopped":37,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":37},{"fullName":5,"class":6},"Celltex Therapeutics Corporation","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Group","EXPERIMENTAL","Each subject receives three separate doses of 200 million allogeneic adipose-derived mesenchymal stem cells via intravenously infusion on days 0, 3, and 6 with a total of 600 million AdMSCs during 7 days in addition to their standard of care.",[13],"Biological: Allogeneic adipose-derived stem cells",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","The control group will receive placebo infusion on day 0, 3 and 6 along with standard of care.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Allogeneic adipose-derived stem cells","Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue",[15,9],[26],"Celltex-AdMSCs",[28],{"name":29,"affiliation":30,"role":31},"Derek W Guillory, MD","Root Causes Medicine","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Jane Young, Ph.D.","CONTACT","7135901000",null,"jyoung@celltexbank.com",{"type":40,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100440592","phase-2-clinical-study-for-subjects-with-covid-19-using-allogeneic-adipose-tissue-derived-mesenchymal-stem-cells-100440592",false,"NCT05017298","Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells","Clinical Study for Subjects With Coronavirus 2019 (COVID-19) Using Multiple Dose Intravenous Infusions of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)","AdMSCs","Inclusion Criteria:\n\n* Age above 18 years.\n* Male and female\n* Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures\n* Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive\n* Clinical diagnosis meets severe and\u002For critical parameters\n* Male participants must be willing to ensure their partners do not become pregnant either by practicing abstinence or the use of condoms during sexual activity\n\nExclusion Criteria:\n\n* Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start\n* Unwillingness or inability to comply with study procedures\n* Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.\n* Clinically active malignant disease\n* Subjects who are receiving ECMO and CRRT currently\n* History of known pulmonary embolism or known secondary anti-phospholipid syndrome\n* Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)\n* Known or suspected allergic to diphenhydramine.\n* Major trauma or surgery within 14 days of study treatment start\n* Mental condition rendering the subject (or the subject's legally acceptable representative\\[s\\]) unable to understand the nature, scope and possible consequences of the study\n* Alcohol, drug, or medication abuse within one year prior to study treatment start\n* Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study\n* Irreversible severe end organ failure, such as heart failure\u002Fattack, stroke, liver and renal failure due to other disease conditions\n* Patients or family history with hypercoagulable status, such as protein C\u002Fprotein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.\n* History of long-term use of immunosuppressive agents\n* Organ transplants in the past 6 months\n* Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study.\n* Patients with previous pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia before COVID-19 infection. The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.\n* QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test.\n* Subjects are not medically unstable at time of infusion including but not limiting unstable hypertension, pulse, oximetry, etc.","ALL","18 Years",{"count":52,"type":53},30,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.",[59,60],"Corona Virus Infection","Covid19","NOT_YET_RECRUITING","2024-02-05",{"date":64,"type":65},"2024-02-07","ACTUAL",{"date":67,"type":53},"2024-11-01",{"date":69,"type":53},"2026-11-15",{"name":5,"class":6}]