Safety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock

Korábbi kezelés

• Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).
• Contraindications to the investigational drug or study procedures.

Más betegség

• Cardiac arrest.
• Absence of spontaneous cardiac activity.
• Active bleeding or contraindications to heparin use.
• Active autoimmune disease requiring immunosuppressive therapy.
• History of malignancy.
• Infection, including:
  • Active hepatitis B (HBV DNA >1000 copies/mL by PCR), hepatitis C, syphilis, or HIV infection at screening.
  • Uncontrolled systemic fungal, bacterial, viral, or other pathogen infections.
• Active infection requiring treatment.
• History of malignancy.
• Active autoimmune disease requiring immunosuppressive therapy.

Egyéb

• Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).
• Shock due to other causes (e.g., sepsis, hypovolemia).
• Resuscitation duration >30 minutes.
• Persistent electrical instability.
• Pregnant women.

• Age ≥ 18 years and < 80 years.
• Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:
  • 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
  • Signs of impaired organ perfusion, meeting at least one of the following criteria:
  • Altered mental status
  • Cold, clammy skin and extremities
  • Oliguria, with urine output <30 mL/h
  • Arterial lactate level >2 mmol/L
• 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.
• Age ≥ 18 years and ≤ 75 years.
• Has provided written informed consent.
• Hematocrit >30%, lymphocyte count >0.5 × 10\^9/L, platelet count >60 × 10\^9/L.
• Pathogen screening results must be negative for HIV (antigen, core antibody, and RNA), HBV (surface antigen and core antibody), HCV, syphilis, CMV, and EBV.