A Phase I Study of Allogeneic Myocardium-Derived Mesenchymal Stem Cells (HB1011) in Patients With Ischemic Cardiomyopathy

Korábbi kezelés

• New myocardial infarction within 28 days prior to screening, or unstabilized cardiac enzyme levels at screening
• Participation in another clinical trial involving an investigational drug or device within 6 months prior to screening
• Systemic immunosuppressive therapy at protocol-defined high doses, or high-dose short-term steroid therapy within 4 weeks prior to treatment
• Requirement for concomitant major cardiac or aortic procedures at the time of CABG (e.g., valve repair/replacement, aortic surgery)
• Panel reactive antibody (PRA) Class I or II ≥ 50%

Más betegség

• Contraindication to cardiac MRI (e.g., pacemaker, severe claustrophobia)
• History of malignancy within 5 years, severe allergic reaction, prior cardiac surgery (including CABG), stroke within 3 months, or incomplete recovery from major surgery within 12 weeks
• Significant comorbidities at screening, including severe ventricular arrhythmia, uncontrolled atrial fibrillation, severe or unstable COPD, congenital heart disease, active viral or severe infection, autoimmune disease, or active tuberculosis
• Active hepatitis B, hepatitis C, or HIV infection
• Suspected active infection within 48 hours before surgery
• Life expectancy less than 1 year due to non-cardiac conditions
• Severe pulmonary hypertension or conditions requiring resting oxygen therapy
• Severe peripheral arterial disease with rest pain, ischemic ulcer, or gangrene
• Hypersensitivity to bovine-derived proteins
• Any other condition deemed unsuitable for participation by the investigator

Laborértékek

• Severe chronic renal impairment (eGFR < 30 mL/min/1.73m²), renal replacement therapy, or significant hepatic disease
• HbA1c > 10% in patients with diabetes

Egyéb

• Pregnant, breastfeeding, or unwilling to use adequate contraception during the study
• Hemodynamically unstable patients

• Scheduled to undergo coronary artery bypass grafting (CABG) surgery
• Left ventricular ejection fraction (LVEF) ≤ 40%
• Age 19 to 85 years, male or female
• Diagnosed with ischemic cardiomyopathy
• NYHA functional Class II-IV at screening
• Ability to understand the study and willing to provide written informed consent