[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622210":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":18,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":79,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of allogeneic FAP iCDC","EXPERIMENTAL","Administration of FAP immunosuppressive CAR-DC cell therapy in AMI CS. Patients are planned to be enrolled in the dose-escalation trial (1×10\\^5\u002Fkg、4×10\\^5\u002Fkg、and 8×10\\^5\u002Fkg) .The first dose group (4×10⁵\u002Fkg) initially enrolls 3 subjects to observe Dose-Limiting Toxicity (DLT) responses.\n\n1. If no DLT occurs and all 3 subjects demonstrate efficacy after 6 months of treatment, and this dose is determined as the safe and effective dose.\n2. If 1 subject experiences DLT, 3 additional subjects are enrolled. ·If 1\u002F6 subjects develops DLT, and efficacy is not fully achieved in all 6 subjects, escalate to the next dose group (8×10\\^5\u002Fkg). ·If ≥2\u002F6 subjects develop DLT, de-escalate to the previous dose group (1×10\\^5\u002Fkg).\n3. After identifying a safe and effective dose, enrollment will be expanded at this dose to bring the total sample size to 8-10 subjects, to further evaluate safety and efficacy.",[13],"Biological: FAP allogeneic immunosuppressive CAR-DC",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard therapy","NO_INTERVENTION","Patients in the control group do not receive cellular therapy intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","FAP allogeneic immunosuppressive CAR-DC","Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion at the first day of shock.",[9],[26],{"name":27,"affiliation":28,"role":29},"Xinyang Hu, PhD","Second Affiliated Hospital, School of Medicine, Zhejiang University, China","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Jiamin Li, MD","CONTACT","86-18868112006","21818216@zju.edu.cn",[37],{"facility":5,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hangzhou","Zhejiang","310009","China","CN",{"type":44,"coordinates":45},"Point",[46,47],120.16142,30.29365,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":18,"email":53},"Xinyang Hu","86-0571-87783777","hxy0507@zju.edu.cn",{"type":55,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100622210","phase-1-safety-and-efficacy-of-fap-icdc-in-acute-myocardial-infarction-with-cardiogenic-shock-100622210",false,"NCT07380659","Safety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock","Safety and Efficacy of Allogeneic Immunosuppressive CAR-DC Targeting FAP in the Treatment of Acute Myocardial Infarction With Cardiogenic Shock","Inclusion Criteria（patients）:\n\n* Age ≥ 18 years and \\\u003C 80 years.\n* Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:\n\n  1. Post-emergent revascularization (PCI or CABG)\n  2. Systolic blood pressure \\\u003C 90 mmHg for \\>30 minutes, or requiring catecholamine support to maintain systolic blood pressure \\>90 mmHg\n  3. Signs of impaired organ perfusion, meeting at least one of the following criteria:\n\n     1. Altered mental status\n     2. Cold, clammy skin and extremities\n     3. Oliguria, with urine output \\\u003C30 mL\u002Fh\n     4. Arterial lactate level \\>2 mmol\u002FL\n* The patient or their legally authorized representative is capable of providing verbal confirmation of understanding the trial risks, benefits, and treatment alternatives associated with receiving immunosuppressive CAR-DC therapy, and provides written informed consent prior to participation in this clinical trial.\n\nExclusion Criteria（patients）:\n\n1. Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).\n2. Cardiac arrest.\n3. Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).\n4. Shock due to other causes (e.g., sepsis, hypovolemia).\n5. Resuscitation duration \\>30 minutes.\n6. Absence of spontaneous cardiac activity.\n7. Persistent electrical instability.\n8. Active bleeding or contraindications to heparin use.\n9. Active autoimmune disease requiring immunosuppressive therapy.\n10. History of malignancy.\n11. Infection, including:\n\n    * Active hepatitis B (HBV DNA \\>1000 copies\u002FmL by PCR), hepatitis C, syphilis, or HIV infection at screening.\n    * Uncontrolled systemic fungal, bacterial, viral, or other pathogen infections.\n12. Pregnant women.\n13. Contraindications to the investigational drug or study procedures.\n\nInclusion Criteria（donors）:\n\n* Age ≥ 18 years and ≤ 75 years.\n* Has provided written informed consent.\n* Hematocrit \\>30%, lymphocyte count \\>0.5 × 10\\^9\u002FL, platelet count \\>60 × 10\\^9\u002FL.\n* Pathogen screening results must be negative for HIV (antigen, core antibody, and RNA), HBV (surface antigen and core antibody), HCV, syphilis, CMV, and EBV.\n\nExclusion Criteria（donors）:\n\n* Active infection requiring treatment.\n* History of malignancy.\n* Active autoimmune disease requiring immunosuppressive therapy.","ALL","18 Years","80 Years",{"count":67,"type":68},18,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","To study the safety and efficacy of fibroblast activation protein (FAP)-targeted allogeneic immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of acute myocardial infarction with cardiogenic shock and provide a new method for the treatment of acute myocardial infarction with cardiogenic shock.",[74,75,76],"Cardiogenic Shock","Cardiogenic Shock Post Myocardial Infarction","STEMI - ST Elevation Myocardial Infarction",[78],"acute myocardial infarction with cardiogenic shock","NOT_YET_RECRUITING","2026-01-28",{"date":82,"type":83},"2026-02-02","ACTUAL",{"date":85,"type":68},"2026-01-20",{"date":87,"type":68},"2027-02-28",{"name":5,"class":6},1]