About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and < 80 years.
Post-emergent revascularization (PCI or CABG)
Systolic blood pressure < 90 mmHg for >30 minutes, or requiring catecholamine support to maintain systolic blood pressure >90 mmHg
Altered mental status
Disqualifiers
Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).
Cardiac arrest.
Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).
Shock due to other causes (e.g., sepsis, hypovolemia).
Trial design
Parallel
Treatments tested in this trial
FAP allogeneic immunosuppressive CAR-DC
Biological/VaccineEach subject receive FAP immunosuppressive CAR-DC by intravenous infusion at the first day of shock.
Treatment groups
Trial outcomes
Primary outcomes
The proportion of subjects with Dose-limiting toxicity (DLT)
The proportion of participants with DLT as assessed by CTCAE v5.0
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of iCDC treatment-emergent adverse events
Secondary outcomes
All-cause mortality
All-cause mortality at 30 days after iCDC treatment
Systolic blood pressure
Systolic blood pressure (mmHg) measured using a calibrated sphygmomanometer under standardized conditions.
Diastolic blood pressure
Diastolic blood pressure (mmHg) measured using a calibrated sphygmomanometer under standardized conditions.
Mean arterial pressure
The mean arterial pressure (MAP) is calculated using the following formula: MAP=DBP+1/3(SBP-DBP);DBP : Diastolic blood pressure,SBP :Systolic blood pressure
Sponsors and contacts
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