输血（医学）科主导细胞与基因治疗院内质量控制的逻辑基础与实现路径*

doi:10.3969/j.issn.1671-2587.2026.03.002

临床输血与检验 ›› 2026, Vol. 28 ›› Issue (3): 312-316.DOI: 10.3969/j.issn.1671-2587.2026.03.002

输血（医学）科主导细胞与基因治疗院内质量控制的逻辑基础与实现路径^*

马一鸣¹, 马超², 张勇刚³, 李小飞¹

¹首都医科大学附属北京友谊医院输血科,北京 100050;
²解放军总医院第一医学中心血液病科,北京 100853;
³中国医学科学院输血研究所细胞与基因治疗中试基地,成都 610052

收稿日期:2026-03-01 出版日期:2026-06-20 发布日期:2026-07-07
通讯作者: 李小飞,主要从事输血医学方面研究,（E-mail）lixiaofei@ccmu.edu.cn。
作者简介:马一鸣,主要从事输血医学方面研究,（E-mail）transfus_ma@163.com。
基金资助:
^*本课题受国家自然科学基金委员会面上项目（No.82570282）资助

Logical Basis and Implementation Pathway for Transfusion Medicine Department-led In-hospital Quality Control of Cell and Gene Therapy

MA Yiming¹, MA Chao², ZHANG Yonggang³, LI Xiaofei¹

¹Blood Transfusion Department of Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100050;
²Hematology Department of the First Medical Center of the People's Liberation Army General Hospital, Beijing 100853;
³Cell and Gene Therapy Pilot Base of the Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Chengdu 610052

Received:2026-03-01 Online:2026-06-20 Published:2026-07-07

摘要/Abstract

摘要： 细胞与基因治疗（cell and gene therapy, CGT）在我国已形成上市产品、注册临床试验、研究者发起研究及医院自建药品生产质量管理规范（GMP）平台和院内制剂并行发展的格局。CGT以活细胞为核心,质量风险贯穿采集、制备、储运、回输及随访全过程。国际实践表明,输血医学在细胞采集、身份核验、冷链管理、临床放行和不良反应监测等环节发挥了重要作用。当前我国医院端在细胞制备与临床应用之间尚缺乏稳定衔接机制,院内质量责任主体有待进一步明确。输血（医学）科在细胞单采、冷链管理及输注风险控制方面具有成熟经验,与CGT院内质量管理需求高度契合。本文探讨以输血医学为支撑的CGT院内质量控制路径,为体细胞、干细胞及外泌体等治疗的规范开展提供思路。

关键词: 细胞与基因治疗, 体细胞治疗, 干细胞, 输血医学, 质量控制

Abstract: Cell and gene therapy (CGT) in China has evolved into a parallel framework encompassing approved commercial products, registered clinical trials, investigator-initiated trials, hospital GMP platforms, and preparations developed within hospitals. Because CGT relies on living cellular products, quality risks extend across the entire process from collection and manufacturing to storage, infusion, and follow-up. International practice demonstrates that transfusion medicine contributes meaningfully to cellular collection, identity verification, cold chain management, clinical release, and adverse event monitoring. Within Chinese hospitals, a stable quality linkage mechanism between cell manufacturing and clinical administration is currently lacking, and institutional responsibility for in-hospital CGT oversight remains undefined. Transfusion medicine departments possess mature expertise in cell preservation, apheresis technology, cold chain management, and transfusion risk control—capabilities that align closely with in-hospital CGT quality management requirements. This article proposes an in-hospital CGT quality control framework supported by transfusion medicine departments, offering a reference model for the standardized implementation of somatic cell therapy, stem cell therapy, and exosome therapies.

Key words: Cell and gene therapy, Somatic cell therapy, Stem cell, Transfusion medicine, Quality control

中图分类号:

R457.1

马一鸣, 马超, 张勇刚, 李小飞. 输血（医学）科主导细胞与基因治疗院内质量控制的逻辑基础与实现路径^*[J]. 临床输血与检验, 2026, 28(3): 312-316.

MA Yiming, MA Chao, ZHANG Yonggang, LI Xiaofei. Logical Basis and Implementation Pathway for Transfusion Medicine Department-led In-hospital Quality Control of Cell and Gene Therapy[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2026, 28(3): 312-316.

参考文献

[1] Chancellor D,Barrett D,Nguyen-Jatkoe L,et al.The state of cell and gene therapy in 2023[J]. Mol Ther,2023, 31(12):3376-3388.
[2] Mahmoudjafari Z,McGuirk J,Ahmed N. From vision to viability:developing infrastructure for cell and gene therapy programs[J]. Transplant Cell Ther,2026,32(5):557.e1-557.e11.
[3] Jacobs J W,Raza S,Maynard S,et al.Improving transfusion access through improved policy:a call for a less fragmented blood supply[J]. Expert Rev Hematol, 2026,19(3):225-235.
[4] Steffen K M,Spinella P C,Holdsworth L M,et al.Factors influencing pediatric transfusion:A complex decision impacting quality of care[J]. Transfusion,2023, 63(6):1151-1160.
[5] Weber E W,Maus M V,MacKall C L. The emerging landscape of immune cell therapies[J]. Cell,2020,181(1):46-62.
[6] Passweg J R,Baldomero H,Chabannon C,et al.Hematopoietic cell transplantation and cellular therapy survey of the EBMT:monitoring of activities and trends over 30 years[J]. Bone Marrow Transplant,2021,56(7):1651-1664.
[7] Kaminskiy Y,Degtyarev V,Stepanov A,et al.CAR T cell therapy for central nervous system solid tumors:current progress and future directions[J]. Front Immunol,2025, 16:1600403.
[8] Reich-Slotky R,Vasovic L V,Land K J,et al.Cryopreserved hematopoietic stem/progenitor cells stability program-development,current status and recommendations:A brief report from the AABB-ISCT joint working group cellular therapy product stability project team[J]. Cytotherapy, 2022,24(5):473-481.
[9] Damodar S,Ma D D,Ragg S J,et al.Standardization and accreditation in haemopoietic stem cell transplantation—an Asia Pacific perspective[J]. Blood Cell Ther,2021, 4(Spec Edition):S14-S19.
[10] Liu H D,Su L,Winters J L,et al.Considerations for immune effector cell therapy collections:a white paper from the American Society for Apheresis[J]. Cytotherapy, 2022,24(9):916-922.
[11] Hu Y X,Feng J J,Gu T N,et al.CAR T-cell therapies in China:rapid evolution and a bright future[J]. Lancet Haematol,2022,9(12):e930-e941.
[12] Chen D S,Chen Z P,Yuan J B,et al.Research landscape and trends of human umbilical cord mesenchymal stem cell-derived exosomes[J]. Stem Cell Res Ther,2025, 16(1):259.
[13] Yang Y F,Bian L L,Cheng Y,et al.The role and challenges of investigator-initiated trials in the cell and gene therapy products boom in mainland China[J]. Clin Transl Sci,2025,18(2):e70148.
[14] Guha P,Katz S C.Strategies for manufacturing cell therapy products aligned with patient needs[J]. Methods Cell Biol,2022,167:203-226.
[15] Wu A R,Zhang T Y,Yu H K,et al.Mechanisms underlying resistance to CAR-T cell therapy and strategies for enhancement[J]. Cytokine Growth Factor Rev,2025,83:66-76.
[16] Zhang Y,Lan M Y,Chen Y.Minimal information for studies of extracellular vesicles (MISEV):ten-year evolution (2014—2023)[J]. Pharmaceutics,2024,16(11):1394.
[17] Zhao D Q,Ruan J,Wei C,et al.Clinical outcome and immunophenotype of axicabtagene ciloleucel (axi-cel) and relmacabtagene autoleucel (relma-cel) in relapsed/refractory large B-Cell lymphoma on Chinese population:a single-center experience[J]. Ann Hematol, 2025,104(10):5151-5162.
[18] Lee O J,Keating A.Mesenchymal stromal cells:an update[J]. Curr Opin Hematol,2025,32(5):270-278.

输血（医学）科主导细胞与基因治疗院内质量控制的逻辑基础与实现路径^*

Logical Basis and Implementation Pathway for Transfusion Medicine Department-led In-hospital Quality Control of Cell and Gene Therapy

PDF

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

本文评价

关于本刊

作者中心

在线期刊

访问统计

联系我们

[1]	沈淑洁, 巩怀证, 孙昌魁, 卢霞, 徐小茗, 陈妍. 数字孪生技术在输血医学中的应用与思考[J]. 临床输血与检验, 2026, 28(3): 323-327.
[2]	凌亚亭, 张春, 智渊, 张钰, 杜海林, 傅强, 何成涛. 脐带血CD34⁺干细胞四阶段诱导分化为功能性红细胞的体系优化与特征分析^*[J]. 临床输血与检验, 2026, 28(3): 339-344.
[3]	长三角一体化临床输血质量控制与管理联合体, 上海市临床输血质量控制中心, 上海市社会医疗机构协会输血专业委员会, 上海市医学会输血专科分会, 上海市医师协会输血科医师分会. 临床输血全流程清单式质量管理专家共识[J]. 临床输血与检验, 2026, 28(2): 153-161.
[4]	孙莉萍, 于洋. 成熟红细胞 microRNA是无意义的细胞“遗物”，还是具备生物学功能的活性分子?[J]. 临床输血与检验, 2026, 28(1): 18-21.
[5]	李欣蕾, 安宁, 王雅芬, 吴晓双, 陈洁, 何阳, 陈要臻, 胡兴斌. 苯肼诱导慢性溶血性贫血对外周血及骨髓干细胞影响^*[J]. 临床输血与检验, 2026, 28(1): 22-28.
[6]	杨玥, 岳伟, 黄韦华, 李津杞, 李彦欣, 顾海慧. PKA基因过表达与敲除对人诱导多能干细胞体外巨核细胞分化的影响^*[J]. 临床输血与检验, 2026, 28(1): 29-35.
[7]	潘亚东, 丁梦圆, 杨秀秀, 孙亚韵, 凌婧. 造血干细胞移植术后并发过客淋巴细胞综合征1例报道及文献复习^*[J]. 临床输血与检验, 2026, 28(1): 121-126.
[8]	葛霜, 尚玮, 于洋, 汪德清. 输血医学3.0：输血医学的智能化与个性化^*[J]. 临床输血与检验, 2025, 27(6): 754-760.
[9]	岳伟, 杨玥, 周梅, 李津杞, 杨怡, 李彦欣, 钱宝华, 何啸, 顾海慧. hTERT在人诱导多能干细胞体外分化为巨核细胞中的作用^*[J]. 临床输血与检验, 2025, 27(5): 604-612.
[10]	龚瑾, 王海莹, 陈立力, 王辉, 张进进, 邢颜超. 富血小板血浆联合间充质干细胞疗法在组织再生中的研究进展[J]. 临床输血与检验, 2025, 27(5): 736-743.
[11]	付晓艳, 甄自达, 马曙轩. Ⅳ期高危神经母细胞瘤患儿自体造血干细胞移植红细胞输注的影响因素分析[J]. 临床输血与检验, 2025, 27(3): 300-305.
[12]	张印则. 逻辑：输血医学学术论文的核心要素[J]. 临床输血与检验, 2025, 27(3): 315-318.
[13]	张媛媛, 王慧茹, 应美爱, 潘健, 刘磊, 刘会兰. 血浆置换联合抗B细胞治疗药物应用于造血干细胞移植DSA阳性患者中的效果观察^*[J]. 临床输血与检验, 2025, 27(2): 156-162.
[14]	付丽辉, 马春娅, 罗圆圆, 沈伟, 向东, 于洋. 一例意外抗体阳性患者造血干细胞移植后抗体监测结果分析[J]. 临床输血与检验, 2025, 27(2): 169-174.
[15]	徐慧, 张全诚, 许倩文, 薛磊, 王兴兵. 贝林妥欧单抗与CD19 CAR-T细胞治疗急性B淋巴细胞白血病的安全性和短期疗效比较分析^*[J]. 临床输血与检验, 2025, 27(2): 224-233.