[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520120":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":36,"centralContacts":40,"locations":49,"responsibleParty":98,"collaborators":101,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":18,"studyType":119,"phases":120,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":51,"whyStopped":18,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Hospital General Universitario Gregorio Marañon","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase A: 5.000.000 thyTreg \u002Fkg","EXPERIMENTAL","Allogeneic thyTreg 5.000.000",[13],"Biological: Allogeneic thyTreg 5.000.000",{"label":15,"type":16,"description":17,"interventionNames":18},"Phase A: standard of care","NO_INTERVENTION","Standard of care",null,{"label":20,"type":10,"description":21,"interventionNames":22},"Phase B: 10.000.000 thyTreg \u002Fkg","Allogeneic thyTreg 10.000.000",[23],"Biological: Allogeneic thyTreg 10.000.000",{"label":25,"type":16,"description":17,"interventionNames":18},"Phase B: standard of care",[27,33],{"type":28,"name":11,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Treg lymphocytic cells, differentiated, allogeneic, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)",[9],[32],"Allogeneic thyTreg cells",{"type":28,"name":21,"description":29,"armGroupLabels":34,"otherNames":35},[20],[32],[37],{"name":38,"affiliation":5,"role":39},"Rafael Correa-Rocha, PhD","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":18,"email":45},"Marta Martínez-Bonet, PhD","CONTACT","34 915866455","marta.mbonet@iisgm.com",{"name":47,"role":43,"phone":44,"phoneExt":18,"email":48},"Diana Hernández Flórez, PhD","diana.hernandez@iisgm.com",[50],{"facility":5,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Madrid","28007","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],-3.70256,40.4165,{"lat":60,"lon":59},[63,66,68,70,72,74,76,78,80,82,84,86,88,90,92,94,96],{"name":38,"role":43,"phone":64,"phoneExt":18,"email":65},"+34 915866455","rafael.correa@iisgm.com",{"name":42,"role":67,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":69,"role":67,"phone":18,"phoneExt":18,"email":18},"Marjorie Pion, PhD",{"name":71,"role":67,"phone":18,"phoneExt":18,"email":18},"Esther Bernaldo-de-Quirós, PhD",{"name":73,"role":67,"phone":18,"phoneExt":18,"email":18},"Diana Hernández-Flórez, PhD",{"name":75,"role":67,"phone":18,"phoneExt":18,"email":18},"María Abad Ferry, MsC",{"name":77,"role":67,"phone":18,"phoneExt":18,"email":18},"Beatriz Cózar Fernández, MsC",{"name":79,"role":67,"phone":18,"phoneExt":18,"email":18},"Sergio Gil Manso, PhD",{"name":81,"role":67,"phone":18,"phoneExt":18,"email":18},"Rocio López Esteban",{"name":83,"role":67,"phone":18,"phoneExt":18,"email":18},"José Eugenio Guerrero Sanz, MD PhD",{"name":85,"role":67,"phone":18,"phoneExt":18,"email":18},"Carmen Martínez Mata, MD",{"name":87,"role":67,"phone":18,"phoneExt":18,"email":18},"Juan Miguel Gil-Jaurena, MD",{"name":89,"role":67,"phone":18,"phoneExt":18,"email":18},"Carlos Pardo, MD PhD",{"name":91,"role":67,"phone":18,"phoneExt":18,"email":18},"Ramón Pérez-Caballero, MD PhD",{"name":93,"role":67,"phone":18,"phoneExt":18,"email":18},"Ana Pita, MD",{"name":95,"role":67,"phone":18,"phoneExt":18,"email":18},"Mª Eugenia Fernández-Santos, PhD",{"name":97,"role":67,"phone":18,"phoneExt":18,"email":18},"José Luis Vicario Moreno, PhD",{"type":39,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Rafael Correa-Rocha","Principal Investigator",[102],{"name":103,"class":104},"Instituto de Salud Carlos III","OTHER_GOV","100520120","phase-1-cell-therapy-with-treg-cells-obtained-from-thymic-tissue-thytreg-to-control-the-immune-hyperactivation-associated-with-covid-19-andor-acute-respiratory-distress-syndrome-thytech2-100520120",false,"NCT06052436","Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and\u002For Acute Respiratory Distress Syndrome (THYTECH2)","Open Phase I\u002FIIa Clinical Trial to Evaluate the Safety and Efficacy of Allogenic Administration of Treg Cells Obtained From Thymic Tissue (thyTreg) to Control The Immune Hyperactivation Associated With COVID-19 and\u002For Acute Respiratory Distress Syndrome","THYTECH2","Inclusion Criteria:\n\n1. Patient over 18 to 65 years of age\n2. Patient Informed and non-opposed to the research by his medical doctor during hospitalization\n3. Patient with clinical, radiological, gasometric and immunological criteria defined as:\n\n   1. Acute respiratory failure secondary to acute lung injury of noncardiogenic cause\n   2. Pulmonary abnormalities compatible with bilateral alveoloinsterstitial infiltrates by chest imaging (radiograph or scan)\n   3. PaO2\u002FFiO2≤ 300 Presence of at least one of the following markers of inflammation: IL6 \\> 40 pg\u002Fml or ferritin \\>300 ng\u002Fml or CRP \\>3 mg\u002Fdl or increasing over the last 24 hours\n\nExclusion Criteria:\n\n1. Pregnancy or breast feeding\n2. Body mass index \\>35\n3. Patients not expected to survive 48 hours after enrolment based on clinical assessment\n4. Patients with an extracorporeal respiratory support\n5. Neutropenia (absolute neutrophil count \\\u003C1000\u002FuL)\n6. Thrombocytopenia (absolute neutrophil count \\\u003C50000\u002FuL)\n7. Positive serology for HBV, HCV, or HIV at Screening\n8. Life expectancy of less than 6 months due to other pathologies\n9. History of significant underlying pulmonary disease requiring oxygen therapy prior to inclusion.\n10. Patients with a history of autoimmune diseases\n11. Patients with a history of hematopoietic neoplasia or oncology disease\n12. Patients with a history of hematopoietic or solid organ transplant\n13. Patients with a congenital or induced immunodeficiency\n14. Patients received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 moths prior to the screening visit\n15. Patients received other cell therapy in the last 12 months\n16. Patients received intravenous immunoglobulin (IVIg) within 5 moths prior to the screening visit\n17. Patients who have participated or is participating in a clinical research study evaluating COVID-19 or ARDS within 30 days prior to the screening visit","ALL","18 Years","65 Years",{"count":117,"type":118},24,"ESTIMATED","INTERVENTIONAL",[121,122],"PHASE1","PHASE2","The investigators developed a GMP protocol to isolate Treg cells from thymic tissue (thyTreg). The thyTreg cells are being evaluated in a Phase I\u002FII clinical trial to evaluate the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children (NCT04924491), with preliminary results indicating the feasibility and safety of the therapy.\n\nIn addition, thyTreg cells have shown low immunogenicity in the pre-clinical setting, indicating that allogeneic use of these thyTreg cells (allo-thyTreg) would have a low risk of adverse effects. These thyTreg cells could inhibit an excessive inflammation in SARS-CoV-2 infection, or ameliorate the immunological affection underlying Acute respiratory distress syndrome, improving life-threatening manifestations, restoring immune balance, and protecting affected tissues.\n\nThis clinical trial is an open-label Sequential Parallel Group Phase I\u002FII study to evaluate the safety and efficacy of allogeneic thymus derived Tregs (thyTreg) (thyTreg) in controlling the immune dysregulation associated with SARS-CoV-2 infection and\u002For Acute Respiratory Distress Syndrome.",[125],"Systemic Inflammatory Response Syndrome",[127,128,129,130,131,132,133],"Immune Hyperactivation","Regulatory T cell","ARDS","COVID-19","Advanced therapy","Immunotherapy","Th1-Th2 Balance","2025-01-30",{"date":136,"type":137},"2025-02-03","ACTUAL",{"date":139,"type":137},"2023-06-27",{"date":141,"type":118},"2027-12-31",{"name":5,"class":6},1]