Regulatory insights on advanced CAR-T cell products, AAV-based Gene therapies, and medical care/practice in cell and Gene therapies: Report from the 6th Asia partnership conference of regenerative medicine- April 20, 2023

IF 3.4 3区环境科学与生态学 Q3 CELL & TISSUE ENGINEERING

Regenerative Therapy Pub Date : 2024-06-01 DOI:10.1016/j.reth.2024.09.015

Hiroshi Karasawa , Hirokuni Mizoguchi , Bryan Choi , Chia-Ling Hsieh , Masaaki Miyano , Yuu Moriya , Sasikumar Muthusamy , Koji Takakura , Kunihiko Suzuki , Yoshie Tsurumaki , Takeshi Watanabe , Karen Wen , Tomohiro Yoneda , Ta-Tung Yuan , Masayuki Nomura

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引用次数: 0

Abstract

The 6th Asia Partnership Conference of Regenerative Medicine (APACRM) was held in person with online on April 20, 2023, to promote the regulatory harmonization of regenerative medicine products throughout Asia. Recognizing domestic regulatory guidelines within each country and region and the underlying rationales are important initial steps toward harmonizing regulations. The 6th APACRM featured an open dialog regarding non-clinical evaluation for advanced CAR-T products, regulation of clinical trials for AAV-based gene therapies, and cell and gene therapies provided to patients as medical care/medical practices without market authorization through presentations from the industry and panel discussions with regulatory agencies. The latest updates on regenerative medicine in each country and region are introduced. This paper summarizes the proceedings of the 6th APACRM for public dissemination to foster future discussions.

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关于先进 CAR-T 细胞产品、基于 AAV 的基因疗法以及细胞和基因疗法医疗护理/实践的监管见解：第六届亚洲再生医学合作会议报告--2023 年 4 月 20 日

第六届亚洲再生医学合作大会（APACRM）于 2023 年 4 月 20 日在线举行，旨在促进整个亚洲地区再生医学产品的监管协调。认识每个国家和地区的国内监管准则及其基本原理是实现监管协调的重要第一步。在第六届亚太再生医学大会上，与会代表就先进 CAR-T 产品的非临床评估、基于 AAV 的基因疗法的临床试验监管，以及未经市场授权作为医疗保健/医疗行为提供给患者的细胞和基因疗法等问题进行了开放式对话。会议还介绍了各个国家和地区再生医学的最新进展。本文总结了第六届亚太再生医学大会的会议情况，以便向公众传播，促进未来的讨论。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Regenerative Therapy Engineering-Biomedical Engineering

CiteScore

6.00

自引率

2.30%

发文量

106

审稿时长

49 days

期刊介绍： Regenerative Therapy is the official peer-reviewed online journal of the Japanese Society for Regenerative Medicine. Regenerative Therapy is a multidisciplinary journal that publishes original articles and reviews of basic research, clinical translation, industrial development, and regulatory issues focusing on stem cell biology, tissue engineering, and regenerative medicine.