[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital General Universitario Gregorio Marañon\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":195},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,58,84,116,139,163],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100641243","automated-passive-case-finding-for-advanced-liver-fibrosis-in-masld-the-liverseek-programme-100641243",false,"NCT07658755","Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme","Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)","LiverSeek","Inclusion Criteria:\n\n1. Age between 50 and 75 years (inclusive)\n2. Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres\n3. Presence of at least one of the following metabolic risk factor combinations:\n\n   * ALT above the upper limit of normal AND HbA1c ≥6.5%\n   * ALT above the upper limit of normal AND BMI \\>30 kg\u002Fm²\n   * BMI \\>30 kg\u002Fm² AND HbA1c ≥6.5%\n\nExclusion Criteria:\n\n1. Age \\\u003C50 years or \\>75 years\n2. Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)\n3. Prior fibrosis assessment within the preceding 12 months.","ALL","50 Years","75 Years",{"count":21,"type":22},3000,"ESTIMATED","24 Months","OBSERVATIONAL","LiverSeek is a fully automated, passive case-finding programme for advanced liver fibrosis associated with metabolic dysfunction-associated steatotic liver disease (MASLD) in primary care. The programme operates through the Laboratory Information System (LIS; Modulab\u002FBiwer Analytics) of the Clinical Biochemistry Laboratory at Hospital General Universitario Gregorio Marañón (HGUGM), covering approximately 350,000 inhabitants across 11 peri-urban primary care centres affiliated to SERMAS (Servicio Madrileño de Salud) in Madrid, Spain.\n\nWhen a high-risk patient (age 50-75 years with ≥1 of: ALT above ULN + HbA1c ≥6.5%; ALT above ULN + BMI \\>30; BMI \\>30 + HbA1c ≥6.5%) undergoes a routine blood test in primary care, the LIS automatically calculates FIB-4. If FIB-4 \\>1.30, the system reflexively orders ELF and MASEF from the same serum sample, without any action required from the primary care clinician. Patients with a positive second-step NIT (ELF ≥9.8 or MASEF ≥0.33) receive an automatic alert directing them to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical evaluation.\n\nThe primary objective is to evaluate the prevalence of hepatic fibrosis in the high-risk population using this single-step automated strategy. Secondary objectives include head-to-head diagnostic comparison of FIB-4+ELF vs FIB-4+MASEF vs FIB-4+FAST for histologically-confirmed endpoints (significant fibrosis ≥F2, advanced fibrosis ≥F3, at-risk MASH), evaluation of the Liver Risk Score, and a health-economic analysis. A sub-study evaluates a nurse-led structured lifestyle intervention in NIT-positive patients.",[27,28,29,30,31,32],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Liver Fibrosis","Non-alcoholic Fatty Liver Disease NAFLD","Type 2 Diabetes Mellitus","Obesity","Obesity Type 2 Diabetes Mellitus",[34,35,36,37,38,39,40,41,42,43,44],"MASLD","MAFLD","NAFLD","liver fibrosis","FIB-4","ELF","MASEF","screening","passive screening","advanced practice nurse","lifestyle intervention","RECRUITING","2026-06-14",{"date":48,"type":49},"2026-06-22","ACTUAL",{"date":51,"type":49},"2024-10-01",{"date":53,"type":22},"2027-09-01",{"name":55,"class":56},"Hospital General Universitario Gregorio Marañon","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100641217","phase-3-single-dose-double-blind-placebo-controlled-cross-over-sddbpcco-shiftability-study-will-be-followed-by-a-10-week-open-label-study-with-arbaclofen-4-weeks-of-titration-and-then-6-weeks-of-activestable-treatment-the-effects-of-arbaclofen-on-target-eeg-and-erg-metrics-will-be-associated-with-th-100641217","NCT07655115","Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active\u002FStable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th","A Follow-Up Shiftability Study of Arbaclofen With an Open-Label Extension for the Study of Biomarkers in Children and Adolescents With Autism Spectrum Disorders.","Inclusion Criteria:\n\n* Signed Written Informed Consent a.Participants or their legal representative must have signed and dated an IRB\u002FIEC approved written informed consent form\n* Diagnosis of an Autism Spectrum Disorder according to the DSM-5 criteria\n* Participation in the AIMS-2 CT1 (ages at recruitment 5 to 17).\n* Current pharmacological treatment regimen affecting behaviour has been stable for at least 6 weeks prior to screening and is expected to be stable during the duration of the study\n* Current psychotherapeutic\u002Fpsychosocial interventions affecting behaviour stable for 3 months prior to screening and expected to be stable during the duration of the study\n* Participants with a history of seizure disorder must currently be receiving stable treatment with anticonvulsant medication and must have been seizure free for 6 months prior to screening or must be seizure free for 3 years prior to screening if not currently on a stable (\\>3 months) dose of antiepileptics\n* Male or female participants 7 to 23 years of age at the time of providing consent, inclusive.\n* Reside or regular contact (at least twice a week) with the parent\u002Fcarer who is interviewed for the study.\n* Negative pregnancy test for females of childbearing potential (participant has experienced onset of menses)\n* Females of childbearing potential who are sexually active must agree to use a highly effective form of contraception (i.e., existing surgical sterilization, complete or abstinence or a combination of two affective forms of contraception, such as, for example, condoms plus hormonal treatment). Please, refer to Appendix 4 for a complete list of acceptable contraception methods.(protocol)\n* Male participants with female partners of childbearing potential are eligible to participate if they agree to the conditions stated in section 8.2.1.(protocol)\n\nExclusion Criteria:\n\n* Participants with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.\n* Participants who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole or other GABA-related medications (e.g. gabapentin or pregabalin) other than arbaclofen in the context of AIMS-2 CT1\n* Participants who are currently receiving pharmacologic treatment affecting behaviour (see concomitant medication section) need to have a stable dose during the 6 weeks prior to the screening visit and for the duration of the study.\n* Participating in programs including non-pharmacologic educational, behavioural, and\u002For dietary interventions affecting behaviour, participation in these programs must have been continuous during the 3 months prior to screening and participants or their parent\u002Fcaregiver\u002FLAR may not electively initiate new or modify ongoing interventions for the duration of the study. Typical school vacations are not considered modifications of stable programming\n* Participants who have taken another investigational drug within the last 30 days.\n* Participants with evidence of any significant haematological, endocrine, cardiovascular (including uncorrected symptomatic congenital heart disease), respiratory, renal, hepatic, or gastrointestinal disease, not including mild common paediatric diseases in these areas that are stable (e.g. mild asthma, constipation, etc.), as judged by the investigator.\n* Participants who are not able to take oral medications.\n* Participants who have a history of hypersensitivity to racemic baclofen\n* Participants with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine.\n* Active peptic ulceration as Baclofen stimulates gastric acid secretion.\n* Porphyria.\n* Participants who are currently engaged in illicit drug use or alcohol abuse, according to DSM-5 criteria.\n* Participants who have previously participated in a clinical trial with arbaclofen (other than our AIMS-2-CT1).\n* Women who are breastfeeding","0 Years","64 Years",{"count":68,"type":22},103,"INTERVENTIONAL",[71],"PHASE3","study with arbaclofen (4 weeks of titration and then 6 weeks of active\u002Fstable treatment). The effects of arbaclofen on target EEG and ERG metrics will be associated with the clinical response in measures of social and general function, adaptive behaviour, social anxiety, sensory behaviours, global functioning, and quality of life in Children and Adolescents with Autism Spectrum Disorders",[74],"Autism Spectrum Disorders","2026-06-12",{"date":77,"type":49},"2026-06-17",{"date":79,"type":49},"2025-11-20",{"date":81,"type":22},"2026-12-31",{"name":55,"class":56},5,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":95,"studyType":24,"phases":4,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":57},"100634271","evaluation-of-the-bmpr2-activin-signaling-pathway-in-group-ii-pulmonary-hypertension-100634271","NCT07537517","Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.","Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study","BREATHE-PH","Inclusion Criteria:\n\n* Older that 18 years\n* Heart failled patients with clinical indication for invasive hemodynamic assessment\n* Written consent\n\nExclusion Criteria:\n\n* Refulsl to sign the infomred consent\n* Presence of iodinated contrast allergy\n* Ineligibility for HT (for BREATHE-CT substudy)","18 Years",{"count":94,"type":22},150,"12 Months","Previous data from our group showed reduced BMPR2 isoform A in pulmonary hypertension associated with left heart disease (PH-LHD) of valvular origin.\n\nFocusing on dysregulation of the BMPR2-activin pathway, a key regulator of vascular homeostasis, this project uses a multimodal approach combining molecular biology, advanced cardiac imaging, and histology.\n\nIts aim is to determine the role of the BMPR2-activin pathway in the development and regression of PH-LHD.\n\nWe will conduct a prospective observational study with 1-year follow-up in 150 heart failure patients of different etiologies undergoing hemodynamic assessment.\n\nClinical parameters, biomarkers, molecular profiles, and hemodynamic\u002Fechocardiographic variables will be analyzed.\n\nA nested substudy in 40 heart transplant candidates will include thoracic CT for vascular morphometric analysis and histological correlation in explanted hearts versus healthy controls.\n\nWe will also assess reversibility of vascular remodeling one year after transplantation.\n\nResults may redefine PH-LHD classification, enable phenotypic precision-medicine models, guide targeted therapies such as activin inhibitors, and refine transplant criteria in combined pulmonary hypertension.",[98,99,100],"Pulmonary Hypertension Due to Left Heart Disease","Pulmonary Hypertension (PH)","Heart Failure",[102,103,104,105,106,107],"BMPR2","Activin","cardiac transplant","pulomnary hypertension II","gene expression","microRNAs","2026-04-16",{"date":110,"type":49},"2026-04-17",{"date":112,"type":49},"2025-11-01",{"date":114,"type":22},"2028-12-31",{"name":55,"class":56},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":122,"minAge":92,"maxAge":19,"enrollmentInfo":123,"targetDuration":4,"studyType":69,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":57},"100610550","phase-2-a-double-blind-non-inferiority-clinical-trial-to-compare-the-nephroprotection-of-cilastatn-versus-thiosulfate-in-patients-undergoing-debulking-surgery-with-intraoperative-hyperthermic-intraperitoneal-chemotherapy-with-cisplatin-100610550","NCT07229040","A Double-blind Non Inferiority Clinical Trial to Compare the Nephroprotection of Cilastatn Versus Thiosulfate in Patients Undergoing Debulking Surgery With Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Cisplatin.","Inclusion Criteria:\n\n* Age: adult patients aged 18-75 years.\n\nSex: female. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2. General condition: patients eligible for major surgery, with creatinine, bilirubin, and blood count values within or close to the normal range (Hb \\>10 g\u002FdL, leukocytes \\>3,000\u002FmL, neutrophils \\>1,000\u002FmL, platelets \\>100,000\u002FmL).\n\nPatients evaluated by the Anesthesiology Department and deemed fit for surgery. Signed informed consent. Disease confined to the abdomen: CRS + HIPEC is not indicated in patients with pulmonary, bone, or other distant metastases. Patients with limited hematogenous metastases to the spleen or liver may be considered. Patients with regional or distant intra-abdominal lymphatic dissemination may also be considered, provided complete resection is feasible. FIGO stage IVA epithelial ovarian carcinoma at presentation, due to pleural effusion with mediastinal lymph node or splenic metastases, is an indication for neoadjuvant chemotherapy; if response is achieved, CRS + HIPEC may subsequently be considered.\n\nMultidisciplinary Committee evaluation: radiological PCI is assessed, and the likelihood of achieving complete cytoreduction is estimated to determine the indication for CRS + HIPEC.\n\nExclusion Criteria:\n\n* Lack of consent to participate in the clinical trial. Eastern Cooperative Oncology Group Performance Status (ECOG PS) \\> 2. Not eligible for major surgery. Disease not confined to the abdomen, or with findings indicating that optimal cytoreduction is not achievable (e.g., intestinal obstruction, biliary obstruction, ureteral obstruction, or diffuse involvement of the small bowel or mesentery).\n\nKnown hypersensitivity to platinum-based agents.","FEMALE",{"count":124,"type":22},90,[126],"PHASE2","To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin",[129,130],"Debulking Surgery for Ovarian Cancer","Acute Kidney Injury","2025-11-13",{"date":133,"type":49},"2025-11-14",{"date":135,"type":49},"2025-02-21",{"date":137,"type":22},"2028-10-21",{"name":55,"class":56},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":69,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":57},"100592855","phase-3-colchicine-in-chronic-kidney-disease-patients-100592855","NCT06998862","Colchicine in Chronic Kidney Disease Patients","Efficacy of Colchicine in Secondary Prevention of Vascular Events and Renal Progression in Patients With Moderate Chronic Kidney Disease","COLCHIREN","Inclusion Criteria:\n\nAge between 18 and 99 years. Moderate chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) by the CKD-EPI formula between 30 and 59 mL\u002Fmin\u002F1.73 m².\n\nHistory of a previous cardiovascular event:\n\nAcute coronary syndrome. Admission for angina pectoris. Transient ischemic attack or non-cardioembolic ischemic stroke. Coronary revascularization. Peripheral vasculopathy, defined as: embolism or acute peripheral arterial ischemia, or the need for amputation or surgical revascularization.\n\nFinding of coronary artery disease on imaging test.\n\nExclusion Criteria:\n\n* History of allergy or intolerance to colchicine or any of its excipients (dihydrate calcium hydrogen phosphate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate).\n* Current treatment with colchicine, or within the month prior to inclusion.\n* Hospital admission for any cause within the 3 months prior to study inclusion.\n* Active malignant neoplasm (except non-melanoma skin cancer or carcinoma in situ). Patients with a history of malignant neoplasm who have remained disease-free for the past 3 years may be included.\n* Uncontrolled or symptomatic chronic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, ulcerative colitis, etc.).\n* Active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.\n* Liver cirrhosis of any cause, grade B or C according to Child-Pugh.\n* Immunosuppressive treatment within the 12 weeks prior to study inclusion.\n* Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs).\n* Poorly controlled hypertension (\\>160\u002F90 mmHg) at the time of inclusion.\n* Pregnancy and breastfeeding at the time of inclusion. Contraceptive methods are required for women of reproductive age. Women with no capacity for pregnancy are considered to be those with:\n\nHistory of hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal ligation.\n\nDocumented infertility. Postmenopausal women, defined as amenorrhea for more than 12 months without other medical cause. In case of doubt, confirmation with elevated follicle-stimulating hormone (FSH) levels is recommended.\n\nWomen of reproductive capacity must use a method of contraception with proven effectiveness until 8 weeks after the end of the study. Acceptable methods include:\n\nIntrauterine device (IUD) placement at least 6 weeks before study inclusion. Hormonal contraception with progestogens only, associated with ovulation inhibition: oral, injectable, or implantable, at least 6 weeks before study inclusion.\n\nProgestin-releasing intrauterine system (IUS) at least 6 weeks before study inclusion.\n\nCombined hormonal contraception (containing estrogen and progestogens) associated with ovulation inhibition: oral, intravaginal, transdermal, at least 6 weeks before study inclusion.\n\nOther contraceptive methods (sexual abstinence, barrier methods, spermicides, etc.) are not considered acceptable for participation in this study\n\n* Gastric ulcer\n* thrombocytopenia \\\u003C50,000 cells\u002FμL during the month prior to inclusion\n* Neutropenia defined as \\\u003C1500 cells\u002FmcL during the month prior to inclusion.\n* Anemia defined as hemoglobin \\\u003C10.5 g\u002FdL during the month prior to inclusion.\n* History of aplastic anemia diagnosed through bone marrow biopsy.\n* Treatment with CYP3A4 inhibitors and\u002For P-glycoprotein inhibitors (antivirals, azole antifungals, aminoglycosides, cyclosporine) in the month prior to their inclusion in the study.","99 Years",{"count":149,"type":22},744,[71],"The ColchiRen study is a phase 3, controlled, prospective, randomized, double-blind, and multicenter clinical trial. Its main objective is to demonstrate the benefit of low-dose colchicine treatment in secondary prevention of cardiovascular events in patients with moderate CKD. As a secondary objective, it aims to explore the potential beneficial anti-inflammatory effect on the progression of CKD.",[153,154],"Chronic Kidney Disease","Cardiovascular Events","2025-05-21",{"date":157,"type":49},"2025-05-31",{"date":159,"type":49},"2025-02-12",{"date":161,"type":22},"2028-12-30",{"name":55,"class":56},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":69,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":57},"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","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","65 Years",{"count":173,"type":22},24,[175,126],"PHASE1","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.",[178],"Systemic Inflammatory Response Syndrome",[180,181,182,183,184,185,186],"Immune Hyperactivation","Regulatory T cell","ARDS","COVID-19","Advanced therapy","Immunotherapy","Th1-Th2 Balance","2025-01-30",{"date":189,"type":49},"2025-02-03",{"date":191,"type":49},"2023-06-27",{"date":193,"type":22},"2027-12-31",{"name":55,"class":56},""]