决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
英文原题:The activities and regulatory landscape of cellular therapies including hematopoietic cell transplantation in the world.
The activities and regulatory landscape of cellular therapies including hematopoietic cell transplantation in the world.
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包括造血细胞移植(HCT)在内的多种细胞疗法,有望治疗目前缺少有效治疗选择的疾病和医学状况。除HCT外,CAR-T 细胞疗法等多种细胞疗法正处于临床前和临床开发阶段,该领域发展迅速。本文总结包括HCT在内的细胞疗法目前的临床应用情况。所有相关专业人员和组织开展合作,对于克服细胞疗法临床开发和上市后证据收集中的重大挑战十分重要。决策者之间协调一致,也有助于提高监管和卫生技术评估流程的一致性与效率。对于接受细胞疗法患者的长期安全性随访,HCT登记系统能够处理复杂数据,并适合用于未来多种血液系统疾病创新细胞疗法的引入和监测。
A variety of cellular therapies including hematopoietic cell transplantation (HCT) hold the promise to treat medical conditions and diseases that currently have limited or no effective therapeutic options. A number of cellular therapies other than HCT, such as CAR T-cell therapy, are currently in preclinical and clinical development and the field is rapidly growing. The current activity of cellular therapies, including HCT, in the clinical setting are summarized in this article.
Collaborative efforts from all relevant professionals and organizations will be of great importance to overcome substantial challenges in clinical development and post-launch evidence collection of cellular therapies. Harmonization among decision-makers also plays a critical role in reinforcing consistency and improving efficiencies of the regulatory and health technology assessment process.
For the long-term safety follow-up of patients undergoing cellular therapies, registries for HCT are able to manage the complexity of data and in the best position to introduce and monitor future innovative cellular therapies for a variety of hematological disorders.
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