在实验室一侧采用新的方法来加快怀孕期间的临床试验
Ramkumar Menon1, Lauren Richardson1, Ananth Kumar Kammala1
1Division of Basic Science and Translational Research, Department of Obstetrics & Gynecology, The University of Texas Medical Branch at Galveston, Galveston, TX, USA.
Expert opinion on drug metabolism & toxicology
|May 13, 2024
概括
孕妇被排除在药物试验之外. 新方法方法 (NAMs),包括器官芯片和细胞外囊泡,可以加速治疗的发展,以实现更安全的怀孕.
科学领域:
- 生殖药理学和围产医学.
- 开发用于怀孕的新型治疗策略.
背景情况:
- 孕妇经常被排除在临床药物开发之外,导致缺乏安全有效的治疗方法.
- 现有的动物模型和方法不足以研究胎儿和母亲的健康状况以及跨越胎儿和母亲屏障的药物转移.
- 生殖药理学的有限进展是由于缺乏人性化的实验模型和可以安全地穿越胎儿和母亲接口的药物.
研究的目的:
- 通过提出创新的解决方案,解决孕妇被排除在临床试验之外的问题.
- 加快在怀孕期间使用安全有效的治疗方法的开发.
- 为了降低不良妊娠结果的风险,例如早产.
主要方法:
- 使用新方法方法 (NAM) 克服传统临床试验的局限性.
- 开发一个人性化的微生理系统,一个Organ-on-a-chip (OOC) 平台,研究胎儿与母亲的接口 (FMi).
- 研究使用细胞外囊泡 (EVs) 作为能够穿越胎儿母体屏障的药物输送载体.
主要成果:
- 器官在芯片 (OOC) 平台提供了一个人性化的模型来研究FMi并评估药物的疗效和毒性.
- 细胞外囊泡 (EVs) 显示出作为安全,免疫无效的药物输送系统的潜力,可以穿越胎儿与母亲的屏障.
- NAM可以加速用于怀孕期间使用的药物的临床前试验.
结论:
- 新方法方法 (NAM) 对于推进生殖药理学和改善母胎健康至关重要.
- 器官在芯片上的技术和细胞外囊泡代表了围产期研究的重大进展.
- 这些方法可以帮助开发药物,安全地穿越胎儿 - 母亲屏障,减少不良妊娠结果.
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