London Chest Hospital, Bonner Road, London E2 9JX, UK.
Regen Med. 2011 Nov;6(6 Suppl):17-23. doi: 10.2217/rme.11.57.
Cell therapy provides one of the most important solutions to the unmet need for new treatments in cardiovascular disease. This area of research has undergone a rapid translation into humans, with the bone marrow mononuclear cell predominating as the cell type with most clinical data. Confidence in the use of this cell type has grown over the last year with the publication of the results of Phase II/III trials in the setting of acute and chronic ischemia confirming safety and biological activity. A large pan-European outcome study is now being planned, which will definitely address the therapeutic potential of this cell type with respect to mortality. Data for the use of selected populations of cells, bioengineered cells/scaffolds and the resident stem cell population continue to grow, with some of these approaches reported in Phase I clinical trials with promising results. There is still some way to go and these more complicated cell therapy products will need to undergo the same scrutiny that has been applied to the results of the bone marrow mononuclear cell trials to date. Ultimately, these engineered biologics will have to justify the costs involved in producing them by significantly improving on results obtained by using bone marrow mononuclear cells for cardiovascular repair. The continued success of this area of translational medicine relies on the ongoing partnership between clinicians and scientists, who have thus far demonstrated a determined and pragmatic approach to solving some of the complexities of moving from bench to bedside. The next 5-years will see this partnership reach fruition as the long-awaited results of outcome studies of cell therapy in the treatment of cardiovascular disease are published.
细胞疗法为心血管疾病的新疗法提供了最重要的解决方案之一。该研究领域已经迅速转化为人类应用，骨髓单个核细胞作为具有最多临床数据的细胞类型占据主导地位。随着急性和慢性缺血环境中 II/III 期试验结果的发表，证实了其安全性和生物学活性，人们对这种细胞类型的使用信心不断增强。目前正在计划一项大型的泛欧结局研究，该研究肯定会针对这种细胞类型的治疗潜力，解决死亡率问题。关于使用选定的细胞群体、生物工程细胞/支架和固有干细胞群体的数据继续增加，其中一些方法已在 I 期临床试验中报告，结果有一定的前景。还有很长的路要走，这些更复杂的细胞疗法产品需要经过与迄今为止骨髓单个核细胞试验结果相同的严格审查。最终，这些工程生物必须通过使用骨髓单个核细胞进行心血管修复所获得的结果显著改善来证明其生产所涉及的成本是合理的。这一转化医学领域的持续成功依赖于临床医生和科学家之间的持续合作，迄今为止，他们已经展现出一种坚定而务实的方法，解决了从实验室到临床的一些复杂性问题。在未来 5 年内，随着细胞疗法治疗心血管疾病的结局研究的期待已久的结果公布，这种合作关系将取得成果。
