在围产期期间发生的肺和脑损伤导致终身残疾,并且通常由炎症驱动和/或加剧。人羊膜上皮细胞(hAEC),表现出免疫调节作用,抗纤维化,和再生能力,正在探索作为围产期损伤的治疗候选药物。然而,关于可扩展制造的限制,storage,运输,和剂量相关的毒性阻碍了临床转化。从干细胞和干细胞样细胞分离的治疗性胞外囊泡(EV)被认为是治疗功效的关键旁分泌介质。电动汽车的独特特征表明,它们有可能规避传统细胞疗法的局限性。然而,考虑到电动汽车作为治疗剂的新颖性,建议围绕理想的制作方法,隔离,storage,和交付尚未由监管机构创建。在这篇简明的评论中,我们讨论了基于细胞的疗法在围产期医学中的相关性和局限性。我们还回顾了支持将治疗性EVs用于围产期治疗的临床前证据。Further,我们总结了关于足够细胞来源的考虑因素,生物分布,隔离和存储方法,以及发展治疗性电动汽车的监管障碍。
Lung and brain injury that occurs during the perinatal period leads to lifelong disability and is often driven and/or exacerbated by inflammation. Human amniotic epithelial cells (hAEC), which demonstrate immunomodulatory, anti-fibrotic, and regenerative capabilities, are being explored as a therapeutic candidate for perinatal injury. However, limitations regarding scalable manufacturing, storage, transport, and dose-related toxicity have impeded clinical translation. Isolated therapeutic extracellular vesicles (EVs) from stem and stem-like cells are thought to be key paracrine mediators of therapeutic efficacy. The unique characteristics of EVs suggest that they potentially circumvent the limitations of traditional cell-based therapies. However, given the novelty of EVs as a therapeutic, recommendations around ideal methods of production, isolation, storage, and delivery have not yet been created by regulatory agencies. In this concise review, we discuss the pertinence and limitations of cell-based therapeutics in perinatal medicine. We also review the preclinical evidence supporting the use of therapeutic EVs for perinatal therapy. Further, we summarize the arising considerations regarding adequate cell source, biodistribution, isolation and storage methods, and regulatory roadblocks for the development of therapeutic EVs.