[1]郭晓磊,李晓云,孙嘉怿,等.含生长因子骨移植材料的研究进展和监管现状[J].中华老年骨科与康复电子杂志,2023,(06):373-378.[doi:10.3877/cma.j.issn.2096-0263.2023.06.007]
　Guo Xiaolei,Li Xiaoyun,Sun Jiayi,et al.The research development and regulatory state-of-art of bone grafts with growth factors[J].Chin J Geriatr Orthop Rehabil(Electronic Edition),2023,(06):373-378.[doi:10.3877/cma.j.issn.2096-0263.2023.06.007]
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含生长因子骨移植材料的研究进展和监管现状()
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中华老年骨科与康复电子杂志[ISSN:1674-3911/CN:11-9292/R]

卷:
期数:
2023年06期
页码:
373-378
栏目:
综述
出版日期:
2023-12-05

文章信息/Info

Title:
The research development and regulatory state-of-art of bone grafts with growth factors
作者:
郭晓磊; 李晓云; 孙嘉怿; 金乐; 郭亚娟; 史新立
100081 北京，国家药品监督管理局医疗器械技术审评中心
Author(s):
Guo Xiaolei;  Li Xiaoyun;  Sun Jiayi;  Jin Le;  Guo Yajuan;  Shi Xinli
Center for Medical Device Evaluation, Beijing, China
关键词:
骨再生;  骨移植;  骨替代材料;  生长因子;  骨形态发生蛋白
Keywords:
Bone regeneration;  Bone graft;  Bone graft substitutes;  Growth factor;  Bone morphogenic protein
DOI:
10.3877/cma.j.issn.2096-0263.2023.06.007
文献标志码:
A
摘要:
骨移植材料接受食品药品监督管理局（FDA）不同路径的监管审批，其预期的安全性和有效性可能只有FDA审评者清楚，临床医生有必要对监管过程有所了解。FDA的审批路径主要包括4个监管途径：510K批准、研究器械豁免/上市前批准（IDE/PMA）、人细胞、组织和细胞基产品（HTC/P ）和再生医学先进治疗（RMAT）。骨再生修复过程中涉及到多种生长因子，如骨形态发生蛋白-2、4（BMP-2，4）、成纤维细胞生长因子、血管内皮生长因子、血小板源性生长因子（PDGF）和胰岛素样生长因子-1等。Infuse （BMP-2）是重组骨形态蛋白-2（rhBMP-2）与可吸收胶原海绵结合的骨移植材料。骨形成蛋白-1（OP-1）材料2001年获得FDA批准用于替代自体骨移植治疗长骨顽固性骨不愈合。PDGF-BB材料是rhPDGF与β-磷酸三钙结合制成，2015年获得FDA批准用于踝关节融合术。iFactorTM是P-15吸附在无机矿物物质上在水凝胶载体中制成的肽增强骨移植材料，2005年FDA批准可用于单节段颈椎前路椎间融合术。我国已有4家公司含生长因子的骨移植材料获得国家药品监督管理局批准，所含的生长因子均为rhBMP-2，与国外相比产品的种类还有很大的差距。组织工程骨材料是组织工程三要素即支架、细胞、生长因子的有效结合，将使骨移植材料的科技含量、有效性得到进一步提高。国家药品监督管理局对骨移植材料应根据产品组成进行分类细化，增加审批路径，提高监管水平，促进科研成果的转化。
Abstract:
Bone graft materials are subject to various regulatory approval pathways by the FDA (Food and Drug Administration). The expected safety and efficacy of bone grafts may only be clear to FDA reviewers, but difficult for clinical physicians to anticipate. The FDA’s regulatory pathways mainly include of four pathways: 510K approval, IDE/PMA (Investigational Device Exemption/Premarket Approval), HTC/P (human cells, tissues, and cellular and tissue-based products), and RMAT (Regenerative Medicine Advanced Therapy). The bone regeneration process involves various growth factors, such as bone morphogenetic proteins-2, 4(BMP-2, 4), fibroblast growth factors, vascular endothelial growth factors, platelet-derived growth factors (PDGF), and insulin-like growth factor-1, etc. Infuse (BMP-2) is a graft material that combines rh-BMP-2 with an absorbable collagen sponge. OP-1 (BMP-7) was approved by the FDA in 2001 to replace autograft in treating recalcitrant long bone nonunions. PDGF-BB materials are made by combining rhPDGF with β-tricalcium phosphate, and were approved by the FDA in 2015 for surgical fusion of ankle. iFactorTM is a peptide-enhanced bone graft material manufactured by adsorbing P-15 onto inorganic mineral matter and hydrogel carriers, which was approved by the FDA in 2005 for anterior cervical discectomy and fusion in single-level procedures. Four products of rhBMP-2 enhanced bone grafts are approved in China. In comparison with foreign countries, there is a significant gap in the variety of products containing growth factors and bioactive factors in China. The medical device of tissue engineering consist of three basic elements of tissue engineering such as carrier, cell, and growth factors, which were combined effectively, and enhance the scientific content and effectiveness and bone grafts and bone graft substitutes.The National Medical Products Administration should refine the approval pathways for bone graft materials containing growth factors and bioactive molecules based on product composition, improve the timeliness of the regulatory process, and enhance translational scientific level.

相似文献/References:

[1]华堃池,冯江涛,杨雄刚,等.脱钙骨基质在四肢植骨中应用的有效性及安全性的系统评价与Meta分析[J].中华老年骨科与康复电子杂志,2018,(04):235.[doi:10.3877/cma.j.issn.2096-0263.2018.04.009]
　Hua Kunchi,Feng Jiangtao,Yang Xionggang,et al.The effectiveness and safety of demineralized bone matrix in limbs bone grafting: a systemicreview and meta-analysis[J].Chin J Geriatr Orthop Rehabil(Electronic Edition),2018,(06):235.[doi:10.3877/cma.j.issn.2096-0263.2018.04.009]

备注/Memo

备注/Memo:
基金项目：国家药监局中国药品监管科学行动计划第二批重点项目：新型生物材料安全性有效性评价研究
更新日期/Last Update: 2023-12-26