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发展中国家的嵌合抗原受体T细胞(CAR-T)疗法:我们该等待多久?

CAR-T cell therapy in developing countries: how long should we wait?

作者信息

Gautam Sanjivan, Gautam Balram, Shilpakar Ramila, K C Sudhamshu, Kurmi Om P

机构信息

Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA

Center for Regenerative Medicine, Kathmandu, Nepal.

出版信息

J Immunother Cancer. 2024 Dec 22;12(12):e009611. doi: 10.1136/jitc-2024-009611.

Abstract

Low- and middle-income countries (LMICs) face a significant burden of cancer prevalence and incidence. However, the survival rates for patients with cancer in these regions are notably lower than those in high-income countries, primarily due to late diagnosis and limited access to advanced treatments. Chimeric antigen receptor (CAR) T-cell therapy has demonstrated promising outcomes in certain terminally ill patients with cancer, yet access to this treatment remains limited in LMICs, including Nepal.The Center for Regenerative Medicine in Nepal has initiated efforts to make CAR-T cell therapy accessible to patients with cancer at a substantially reduced cost. This initiative includes successful research to test the feasibility of local laboratory capabilities using reagents sourced locally or from developed countries. Additionally, a Good Manufacturing Practicies (GMP) grade CAR-T cell manufacturing facility is being established to commence clinical manufacturing. This endeavor has encountered several challenges, including technical difficulties, regulatory barriers, and resource limitations, which could provide valuable insights for other developing countries. This experience from Nepal highlights the importance of interdisciplinary collaboration, shared knowledge, funding, and innovative solutions from the global scientific community to achieve equitable access to advanced medical treatments.

摘要

低收入和中等收入国家(LMICs)面临着癌症患病率和发病率的沉重负担。然而,这些地区癌症患者的生存率明显低于高收入国家,主要原因是诊断延迟和获得先进治疗的机会有限。嵌合抗原受体(CAR)T细胞疗法在某些晚期癌症患者中已显示出有前景的结果,但在包括尼泊尔在内的低收入和中等收入国家,获得这种治疗的机会仍然有限。尼泊尔再生医学中心已开始努力以大幅降低的成本让癌症患者能够获得CAR-T细胞疗法。该倡议包括成功开展研究,以测试使用当地采购或从发达国家获取的试剂的当地实验室能力的可行性。此外,正在建立一个符合药品生产质量管理规范(GMP)等级的CAR-T细胞制造设施,以开始临床生产。这项工作遇到了几个挑战,包括技术困难、监管障碍和资源限制,这些可能为其他发展中国家提供宝贵的见解。尼泊尔的这一经验凸显了跨学科合作、知识共享、资金以及全球科学界创新解决方案对于实现公平获得先进医疗治疗的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cb6c/11664337/2857f2d3e0af/jitc-12-12-g001.jpg

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