Department of Urology, Vanderbilt Medical Center, A-1302 Medical Center North, Nashville, TN, 37232, USA.
World J Urol. 2020 Sep;38(9):2095-2099. doi: 10.1007/s00345-019-03018-9. Epub 2019 Dec 13.
Stress urinary incontinence (SUI) remains a prevalent condition with substantial economic and quality-of-life impact. Treatment for incontinence historically culminates with invasive surgical procedures with recognized complication profiles. Innovative directions for SUI therapeutics are on the horizon, including the utilization of adult autologous muscle-derived cells for urinary sphincter regeneration (AMDC-USR). Herein, we visit fundamental concepts of innovative regenerative medicine technologies for urologic applications.
Synopsis of contemporary literature review regarding adult autologous muscle-derived cells for urinary sphincter regeneration is presented.
Current published literature presents safety and efficacy data regarding AMDC-USR injection in 80 patients at 12-month follow-up. In these early studies, no long-term adverse events were reported and patients undergoing cellular injection at higher doses revealed at least 50% reduction in stress leaks and pad weight at 12-month follow-up. All dose groups demonstrated statistically significant improvement in patient-reported incontinence-specific quality-of-life scores at 12-month follow-up. Conclusions from the pooled analyses indicate that injection of AMDC-USR across a range of dosages appears safe. Efficacy data suggest a dose response with more patients responsive to the higher doses of AMDC-USR.
Applications for utilization of autologous cellular therapies for treatment of SUI, and conceivably multiple additional indications, are approaching realization. Multiple Phase III randomized, placebo-controlled studies for AMDC-USR are concluding or ongoing to launch this regenerative option for the millions of patients who may ultimately benefit.
压力性尿失禁(SUI)仍然是一种普遍存在的疾病,对经济和生活质量有重大影响。既往治疗尿失禁的方法最终都采用有公认并发症的侵入性手术。SUI 治疗的创新方向已经出现,包括利用成人自体肌肉源性细胞进行尿道括约肌再生(AMDC-USR)。在此,我们探讨了用于泌尿科的创新再生医学技术的基本概念。
对成人自体肌肉源性细胞用于尿道括约肌再生的当代文献综述进行了概述。
目前已发表的文献提供了 80 例患者在 12 个月随访时接受 AMDC-USR 注射的安全性和疗效数据。在这些早期研究中,未报告长期不良事件,接受高剂量细胞注射的患者在 12 个月随访时压力漏尿和尿垫重量至少减少 50%。所有剂量组在 12 个月随访时的尿失禁特定生活质量评分均有统计学显著改善。汇总分析的结论表明,在一系列剂量范围内注射 AMDC-USR 是安全的。疗效数据表明存在剂量反应,更多患者对高剂量 AMDC-USR 有反应。
利用自体细胞疗法治疗 SUI 的应用,以及可能的多种其他适应证,即将实现。多项 AMDC-USR 的 III 期随机、安慰剂对照研究正在进行或已经完成,为可能最终受益的数百万患者推出了这种再生选择。