Department of Medicine, University of California, San Francisco, CA 94143-0624, USA.
Chest. 2010 Oct;138(4):965-72. doi: 10.1378/chest.10-0518.
Preclinical studies indicate that allogeneic human mesenchymal stem cells (MSC) may be useful for the treatment of several clinical disorders, including sepsis, acute renal failure, acute myocardial infarction, and more recently, acute lung injury (ALI). This article provides a brief review of the biologic qualities of MSC that make them suitable for the treatment of human diseases, as well as the experimental data that provide support for their potential efficacy for critically ill patients with acute respiratory failure from ALI. The article then discusses which patients with ALI might be the best candidates for cell-based therapy and provides a template for the regulatory and practical steps that will be required to test allogeneic human MSC in patients with severe ALI. There is a dual focus on how to design trials for testing both safety and efficacy.
临床前研究表明,同种异体人骨髓间充质干细胞(MSC)可能对多种临床疾病的治疗有用,包括败血症、急性肾衰竭、急性心肌梗死,以及最近的急性肺损伤(ALI)。本文简要回顾了 MSC 的生物学特性,这些特性使它们适合治疗人类疾病,以及为其对急性呼吸衰竭ALI 危重病患者的潜在疗效提供支持的实验数据。然后,文章讨论了哪些 ALI 患者可能是细胞治疗的最佳候选者,并提供了一个模板,说明在严重 ALI 患者中测试同种异体人 MSC 需要经过监管和实际步骤。双重关注的重点是如何设计试验来测试安全性和疗效。