世界各地监管机构批准的介质细胞干细胞疗法
Luis E Fernández-Garza1,2, Silvia A Barrera-Barrera1, Hugo A Barrera-Saldaña1,3,4
1Laboratorio Nacional de Servicios Especializados de Investigación, Desarrollo e Innovación de Farmoquímicos y Biotecnológicos (LANSEIDI) del CONACyT, Sede Innbiogem SC, Monterrey 64630, Mexico.
Pharmaceuticals (Basel, Switzerland)
|September 28, 2023
概括
介质细胞干细胞 (MSCs) 在细胞疗法中表现有前途,目前正在进行众多临床试验. 然而,只有少数MSC疗法得到批准,这凸显了它们在医疗应用中的挑战.
科学领域:
- 细胞疗法是一种细胞疗法.
- 再生医学是一种再生医学.
- 干细胞生物学 干细胞生物学
背景情况:
- 介质细胞干细胞 (MSC) 是具有广泛治疗潜力的多能原始细胞.
- MSC来源包括成人组织 (骨髓,脂肪) 和新生儿组织 (胎盘,带).
- 全球有大量研究致力于MSC在各种疾病中的应用.
研究的目的:
- 审查介质干细胞 (MSC) 治疗的现状.
- 确定MSC临床翻译的挑战和潜在策略.
- 突出MSC临床试验和批准疗法的全球格局.
主要方法:
- 在全球范围内对涉及MSC的注册临床试验的分析.
- 审查监管部门批准的MSC疗法及其地理分布.
- 检查现有的挑战和为MSC应用提出的解决方案.
主要成果:
- 截至2023年4月,全球已注册了1120个MSC临床试验.
- 只有12种MSC疗法获得了商业化监管批准.
- 九个批准的MSC产品来自亚洲,韩国在批准方面领先.
结论:
- 介质细胞干细胞 (MSCs) 具有重要的未来潜力,可以治疗许多疾病.
- 克服当前的挑战对于MSC疗法的广泛临床采用至关重要.
- 需要进一步的研究和战略开发,以优化MSC的治疗应用.
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