Safety and therapeutic potential of allogeneic adipose-derived stem cell spray transplantation in ischemic
/ɪsˈkiːmɪk/ cardiomyopathy /kɑːrdiˌoʊmaɪˈɑːpəθi/缺血性心肌病
异体脂肪干细胞喷雾移植治疗缺血性心肌病的安全性和治疗潜力
Background: Ischemic cardiomyopathy, characterized by coronary artery atherosclerosis冠状动脉粥样硬化, impairs the myocardial tissue心肌组织. Coronary artery bypass grafting (CABG)冠状动脉旁路移植术 is commonly used to revascularize重建 affected areas and improve patient survival rates; however, it can fail to enhance cardiac function心脏功能. Impaired capillary blood flow may obstruct functional recovery, prompting interest in treatments, such as angiogenic factor administration. Adipose-derived stem cells (ADSCs), known for immune evasion免疫逃逸, have shown the potential to construct capillary networks毛细淋巴管网络 and improve myocardial function心肌功能. This clinical trial evaluated the safety and efficacy of ADSC spray therapy combined with CABG.
Methods: This single-center, randomized, double-blind study involved patients with ischemic cardiomyopathy who were scheduled for CABG and who had a left ventricular ejection fraction 左心室射血分数≤ 40%. The participants were randomized to receive CABG as well as ADSC spray therapy or placebo. The primary endpoints were safety, changes in late gadolinium-enhanced (LGE) 通过晚期钆增强magnetic resonance imaging (MRI) volumes, and feasibility. The secondary endpoints included left ventricular function, exercise tolerance, and heart failure symptoms.
Results: Seven patients were enrolled; of them, six were randomized to receive ADSC therapy (n = 3) or placebo (n = 3). The procedure was successfully completed with minimal adverse events. One patient in the ADSC group developed pleural effusion胸腔积液 that was resolved with drainage胸腔引流. The LGE-MRI volumes decreased in the ADSC group but remained unchanged in the placebo group. Improvements in left ventricular function and exercise tolerance were noted in the ADSC group, with heart failure symptoms improving to New York Heart Association class I. In contrast, the placebo group showed no significant changes, with one patient experiencing worsening symptoms.
Conclusions: ADSC spray therapy combined with CABG demonstrated safety and efficacy in enhancing cardiac function. ADSC likely contributes to capillary network reconstruction, thereby augmenting the benefits of CABG. Future phase II and III trials are warranted to confirm its therapeutic efficacy and long-term outcomes. This novel approach represents a significant advancement in the treatment of ischemic cardiomyopathy and offers a viable strategy for improving myocardial function and patient prognosis. Trial registration This study was registered with the Japan Registry of Clinical Trials (jRCT2053190103) and ClinicalTrials.gov (NCT04695522).
细胞：adipose-derived stem cells，冷冻保存
来源：试验药物由罗特制药株式会社制造
给药方式：were sprayed and transplanted onto the surface of the left ventricle using CO2 gas【喷雾区域在书前已经被识别为缺血性病变区域】
