Institute of Molecular Cardiology, Department of Medicine, University of Louisville, Louisville, Kentucky, USA.
Curr Opin Cardiol. 2022 May 1;37(3):193-200. doi: 10.1097/HCO.0000000000000956.
Clinical trials of adult cell therapy for chronic heart failure are often misrepresented in an unfairly negative light. Results are claimed to be 'negative', 'incremental', or 'modest'. This common misconception is detrimental to medical progress and needs to be dispelled.
Contrary to the false narrative of scientific and lay media, the outcome of recent trials of cell therapy for heart failure has been encouraging and even exciting. Specifically, with the exception of ALLSTAR, in the past 2 years several Phase II-III double-blind, randomized trials have yielded impressive results, demonstrating not just safety but also salubrious effects on cardiac function (MSC-HF) or clinical events (MSC-HF, CONCERT-HF, and DREAM-HF) for at least 1 year after a single administration of cells. Such outcomes were neither incremental nor minor, nor achievable with one dose of any other nondevice therapy for heart failure.
The oft-repeated assertion that cell therapy does not benefit patients with chronic heart failure is based on a misrepresentation of the literature and is contrary to the available scientific evidence. Although the mechanism of action of cell therapy is unclear, research on its use in heart failure should continue, as only rigorous, well designed, Phase III trials can definitely confirm or refute its efficacy.
成人细胞疗法治疗慢性心力衰竭的临床试验经常被不公正地以负面的方式错误呈现。结果被声称是“负面的”、“增量的”或“适度的”。这种常见的误解不利于医学进展，需要予以消除。
与科学和大众媒体的虚假叙述相反，心力衰竭细胞疗法的最近试验结果令人鼓舞，甚至令人兴奋。具体来说，除了 ALLSTAR 之外，在过去的 2 年中，几项 II 期-III 期双盲、随机试验取得了令人印象深刻的结果，不仅证明了安全性，而且在单次细胞给药后至少 1 年对心脏功能（MSC-HF）或临床事件（MSC-HF、CONCERT-HF 和 DREAM-HF）都有有益的影响。这些结果既不是增量的，也不是次要的，也不是任何其他心力衰竭非器械治疗单次剂量就能实现的。
细胞疗法不能使慢性心力衰竭患者受益的一再断言是基于对文献的错误表述，与现有科学证据相矛盾。虽然细胞疗法的作用机制尚不清楚，但应该继续研究其在心力衰竭中的应用，因为只有严格、精心设计的 III 期试验才能明确证实或反驳其疗效。
