Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial - Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial:Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial

开始日期2022-05-01

申办/合作机构-

NCT04372420

/ CompletedN/AIIT

Recombinant Human Bone Morphogenetic Protein-2 In Absorbable Sponge Vs Platelet Rich Fibrin (PRF) In Grade Ii Furcation Defects - A Randomized Controlled Trial

The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.

开始日期2017-12-05

申办/合作机构

SVS Institute of Dental Sciences

TCTR20240618007

/ RecruitingN/AIIT

Comparison of clinical outcome and radiographic between bone morphogenetic protein-2 and beta-Tricalcium phosphate plus iliac bone graft in extreme lateral interbody fusion surgery : Ambidirectional cohort study

开始日期2015-01-01

申办/合作机构-

100 项与阿法地博特明相关的临床结果

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100 项与阿法地博特明相关的转化医学

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100 项与阿法地博特明相关的专利（医药）

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项与阿法地博特明相关的文献（医药）

2025-12-01·INTERNATIONAL DENTAL JOURNAL

Development of Dual-Functional Titanium Implant for Osseointegration and Antimicrobial Effects via Plasma Modification

Article

作者: Chuang, Tsao-Li ; Lin, Chun-Pin ; Chen, Chih-Ying ; Yeh, Chun-Liang ; Chang, Hao-Hueng ; Liao, Shu-Chuan

INTRODUCTION AND AIMS:

Titanium dental implants are widely used in clinical practice; however, they still face challenges such as implant loosening and infection. Recent studies focus on improving integration and infection resistance. In this study, a low-temperature plasma treatment was employed to fabricate a dual-functional modification layer on the titanium implant surface, offering a promising strategy that simultaneously promoted bone integration and effectively inhibited bacterial infection.

MATERIALS AND METHODS:

This was achieved by depositing a hexamethyldisilazane (HMDSZ) film on the surface of titanium implants and grafting a thermosensitive composite hydrogel designed as a drug delivery system. The natural cross-linker genipin was used to immobilize chlorhexidine on the implant collar (2 mm in length). Meanwhile, bone morphogenetic protein-2 was immobilized on the implant body (6 mm in length), ensuring controlled release to promote bone regeneration and provide strong antibacterial effects. Various experimental analyses were conducted to characterize the samples, including assessments of hydrophilicity, functional groups, elemental composition, and surface morphology. Validation was carried out through in vitro tests (cytotoxicity, mineralization, and antibacterial assays) and in vivo animal experiments (bone-to-implant contact and Periotest measurements).

RESULTS:

Biocompatibility tests indicated that the plasma-treated surfaces did not exhibit cytotoxicity and facilitated osteoblast differentiation and osseointegration. The hydrogel effectively served as a carrier for the controlled release of growth factors and antibacterial agents, thereby boosting the osseointegration and antibacterial properties of the titanium implants. In vivo studies in swine models demonstrated superior bone integration and antibacterial efficacy compared to untreated and commercial implants within 2 weeks.

CONCLUSION:

The surface modification method proposed in this study successfully produced titanium implants with dual-functional surfaces, enhancing both osseointegration efficiency and antibacterial capability.

CLINICAL SIGNIFICANCE:

This approach enables implants to perform specific functions through the use of growth factors and antimicrobials, potentially advancing implant technology and improving clinical outcomes.

2025-09-19·ACS Synthetic Biology

High-Level Soluble Expression of Recombinant Human Bone Morphogenetic Protein-2 in Escherichia coli

Article

作者: Cui, Youming ; Liang, Quanfeng ; Liang, Yanqiu ; Zhang, Bin ; Luo, Wei ; Wang, Yi

Human Bone Morphogenetic Protein-2 (hBMP-2) serves as a critical regulator in bone and cartilage formation; however, its industrial application is hindered by its inherent tendency to form inclusion bodies in prokaryotic expression systems. To address this issue, we established a recombinant hBMP-2 (rhBMP-2) expression system using the pCold II plasmid and the SHuffle T7 strain. We explored several strategies to enhance the solubility of rhBMP-2, including coexpression with molecular chaperones, vesicle-mediated secretory expression, fusion expression with synthetic intrinsically disordered proteins (SynIDPs), and fusion expression with small-molecule peptide tags. Our results showed that coexpression with the molecular chaperone pGro7 significantly improved the solubility of rhBMP-2. Fusion with SynIDPs led to complete solubility of rhBMP-2; however, the protein was expressed exclusively in the monomeric form. Among the tested small-molecule peptide tags, GB1 was the most effective, achieving fully soluble rhBMP-2 expression. Western blot analysis confirmed the coexistence of monomeric and dimeric forms of rhBMP-2. Subsequent purification of rhBMP-2 through metal chelate chromatography resulted in an expression level of 109.7 ± 5.0 mg·L^-1. In summary, we successfully demonstrated fully soluble expression of rhBMP-2 in Escherichia coli, providing a valuable foundation for its industrial-scale production.

2025-09-01·JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY

Complication Rates of the Anterior Iliac Crest Bone Graft Donor Site for 426 Pediatric Patients Undergoing Alveolar Bone Grafting

Article

作者: Powell, Kathlyn ; Waite, Peter D ; Kinard, Brian ; Haws, Lane ; Ma, Boyu ; Godfrey, Tanner

BACKGROUND:

The iliac crest bone graft (ICBG) has long been considered the gold standard for secondary alveolar reconstruction in patients with cleft lip and palate. With the advent of grafting alternatives, such as bone morphogenetic protein-2, the morbidity of the iliac crest harvest has come into question.

PURPOSE:

The purpose of this study is to estimate the frequency, types, and identify risk factors for postoperative complications of the anterior ICBG hip donor site.

STUDY DESIGN, SETTING, SAMPLE:

A retrospective cohort study of patients who received alveolar reconstruction with anterior ICBG by 2 surgeons over an 11-year period at the Children's of Alabama Hospital in Birmingham, Alabama, was conducted. Exclusion criteria included previous alveolar graft attempt, age greater than 18 years at the time of repair, or lack of postoperative follow-up.

PREDICTOR VARIABLE:

The predictor variable was a set of risk factors associated with complications and included sex, age at surgery, and cleft type (unilateral vs bilateral).

MAIN OUTCOME VARIABLE:

The main outcome variable was donor site morbidity defined as the presence of complications, prolonged length of stay, or readmission. Complications included gait disturbance, transient hypoesthesia, and hypertrophic scar.

COVARIATES:

Covariates included length of follow-up and alveolar cleft graft timing (secondary vs tertiary).

ANALYSES:

Descriptive and bivariate analyses were completed. The level of statistical significance was P < .05.

RESULTS:

The sample size was composed of 426 subjects with a mean age of 7.9 ± 2.3 years. Of the total subjects, 211 (49.5%) patients were male and 215 (50.5%) patients were female. Overall, 11 (2.6%) subjects experienced complications associated with the anterior iliac crest donor site. The most prevalent anterior iliac crest donor site complications included transient gait disturbance 0.7% (n = 3), hypertrophic scar 0.7% (n = 3), and transient hypoesthesia 0.5% (n = 2). One subject experienced prolonged length of stay, and none required readmission. There were no study variables associated with donor site morbidity.

CONCLUSION:

The overall morbidity associated with anterior ICBG for alveolar cleft repair remains low, with a complication rate of 2.6% (n = 11) associated with the donor site. These results offer strong evidence of the overall safety and minor morbidity of the ICBG harvest for alveolar cleft repair.

项与阿法地博特明相关的新闻（医药）

2024-06-12

·生物探索

Adv Sci丨陈洛南组合作揭示原发性膜性肾病中足细胞的致病性骨形态发生蛋白-2通路

引言近日，国际学术期刊Advanced Science在线发表了中国科学院分子细胞科学卓越创新中心（生物化学与细胞生物学研究所）陈洛南研究组联合上海交通大学医学院附属仁济医院肾脏科牟姗研究组的最新合作研究成果：Podocyte Pathogenic Bone Morphogenetic Protein-2 Pathway and Immune Cell Behaviors in Primary Membranous Nephropathy。该研究建立了目前为止最大规模的原发性膜性肾病（Primary Membranous Nephropathy, PMN）单细胞转录组数据库，结合生物信息学分析、患者肾脏穿刺活检病理切片免疫染色以及体外细胞培养实验，发现了PMN患者肾脏足细胞中骨形态发生蛋白-2（Bone Morphogenetic Protein-2, BMP2）通路激活，导致肾小球基底膜（Glomerular Basement Membrane, GBM）增厚这一PMN的特征性病理改变。并且，通过原创的动态网络标志物分析，预测到了一个与PMN病理转变临界点相关的细胞状态。此外，该研究还揭示了PMN肾脏中的免疫细胞独特的生物学改变，包括巨噬细胞浸润增加、多种功能激活，记忆B细胞和浆细胞活化等。慢性肾脏病给人类健康造成严重负担，蛋白尿是其核心表现之一。大量蛋白尿（>3.5g/24h）往往引起肾病综合征（Nephrotic Syndrome, NS），会并发严重的全身感染、致死性血栓栓塞、急性肾损伤以及代谢紊乱，严重影响患者长期预后；此外，还会导致慢性肾脏病进展为终末期肾病，患者需要进行肾脏替代治疗（透析和肾移植）以维持生命。PMN是一种自身免疫性肾小球疾病，主要临床表现为蛋白尿，是引起成人NS最常见的原发性原因。阐明PMN的发病机制和信号通路对肾脏内科常见疾病的诊断和治疗具有重要意义。肾脏组织学结构复杂、细胞类型众多，包括肾小球、肾小管、肾间质的固有细胞群和浸润的各类免疫细胞群。PMN由自身抗体靶向足细胞表面自身抗原所致，形成的抗原抗体复合物激活补体，导致肾脏滤过屏障破坏，使血浆中蛋白异常渗漏到尿液中形成蛋白尿。足细胞属于肾脏中的稀有细胞类型，因此，其在疾病中的异常信号往往容易被掩盖。该研究纳入了11位PMN患者和7位健康肾移植供体的肾脏穿刺样本，进行单细胞转录组测序。在经过精细的细胞聚类分析后，研究人员在肾小球细胞大类中分离出了细胞数量可观的足细胞簇，并从中发现，PMN患者足细胞中BMP2表达上调，同时GBM基质的主要成分IV型胶原亚基COL4A3、COL4A4表达上调。研究人员判断这一通路可能与PMN的典型病理特征——GBM病理性增厚密切相关。 BMP2属于转化生长因子-β（Transforming Growth Factor-β, TGFβ）超家族成员，通过磷酸化SMAD家族分子，进一步调控下游基因表达，与损伤修复、细胞外基质产生和组织纤维化密切相关。基于此，研究人员在体外培养了永生化小鼠足细胞株并使用BMP2重组蛋白进行刺激，发现足细胞中BMP2/pSMAD1/COL4通路激活，IV型胶原的α3和α4亚基表达上升，与单细胞转录组分析结果相一致。同时对患者和对照组的肾脏病理切片进行了免疫染色，在蛋白水平证实了PMN足细胞中BMP2/pSMAD1/COL4通路的激活。该工作还探究了该通路的上游，发现补体成分C3a和C5b-9刺激能够促进BMP2表达并激活下游反应，从而将PMN发病机制中的补体系统激活，与GBM病理性增厚相关联，为理解PMN的病理生理提供了重要的理论基础。考虑到足细胞作为PMN的重要靶细胞，其在PMN发生发展过程中可能存在着关键的状态转变，该研究基于拟时序分析划定了PMN足细胞的三个连续状态，利用陈洛南研究组原创的动态网络标志物（Dynamic network biomarkers，DNB）算法，从中预测到了处于PMN病理转变临界点附近的一群足细胞。该状态下的足细胞中，BMP2分子所在的基因调控网络发生了极大的表达波动，并可能影响到下游细胞外基质成分的表达。作为一种局限于肾脏的自身免疫病，PMN肾脏中的免疫环境也发生了独特的改变。研究发现PMN肾脏中巨噬细胞浸润增加，它们可能由经典单核细胞分化而来，最终呈M2极化的抗炎表型，并且通过表达载脂蛋白、抗原加工提呈分子、趋化因子发挥着复合的功能。此外，PMN肾脏中B细胞呈明显活化，高表达抗原加工提呈分子以及产生免疫球蛋白IgG分子。细胞间相互作用分析提示，PMN患者肾脏中的免疫细胞彼此之间、同肾脏固有细胞之间呈现出精密而复杂的调控网络。综上，该工作对肾小球足细胞及免疫细胞在PMN发生发展中的作用提供了新的见解，从而有助于进一步揭示PMN的病理生理机制。自身免疫诱导、补体介导的足细胞内BMP2/pSMAD1/COL4通路激活，导致了PMN肾小球基底膜增厚的病理性改变（Credit: Advanced Science）原文链接 http://doi.org/10.1002/advs.202404151 责编|探索君排版|探索君文章来源|“BioArtMED” End 往期精选围观一文读透细胞死亡(Cell Death) | 24年Cell重磅综述（长文收藏版）热文 Cell | 是什么决定了细胞的大小？热文 Nature | 2024年值得关注的七项技术热文 Nature | 自身免疫性疾病能被治愈吗？科学家们终于看到了希望热文 CRISPR技术进化史 | 24年Cell综述

临床研究

2023-11-25

·美通社

美敦力康辉携AiBLE数智骨科一体化亮相第二十二届中国骨科年会

引领行业迈入数智化时代，助力中国骨科高质量发展西安 2023年11月25日 /美通社/ -- 11月22日至26日，由中华医学会、中华医学会骨科学分会主办，陕西省医学会、西安交通大学第二附属医院承办，河北医科大学第三医院协办的第二十二届骨科学术会议暨第十五届COA学术大会在西安圆满召开。来自国内外的知名骨科专家及行业领军企业汇聚一堂，共话国内外骨科领域前沿创新和转化成果。美敦力康辉携 AiBLE™数智骨科一体化解决方案全阵容亮相本次行业盛会，与临床专家及业内领军企业共同探索中国骨科诊疗发展新趋势，引领行业迈入全病程数智化管理新时代。第二十二届骨科年会美敦力康辉展台重磅亮相，以一流解决方案领航骨科数智化在以无限符号为概念设计的展台上，由美敦力康辉全球领先的骨科内植入物和脊柱手术机器人、手术导航系统、术中影像系统、手术动力系统等智能设备组成的 AiBLE™ 数智骨科一体化解决方案以全阵容亮相，并生动呈现了 AiBLE™数智骨科创新生态实现居家、门诊、手术室和术后康复全覆盖的行业发展愿景。作为中国大陆获得国家药监局批准的"同品种首个"，Infuse™骨修复材料也在本次COA上面向广大专业观众与临床医生重磅展出。Infuse™骨修复材料是获得"自体髂骨替代物"的骨修复材料，它的上市进一步充实了 AiBLE™数智骨科一体化解决方案的产品线，将为广大中国医生与患者带来更高的临床获益和经济价值 [1][2][3] ，助力实现 "健康骨骼，健康中国"。同时，搭载了nanoLOCK™界面技术的Adaptix™椎间融合器（该产品已获得国家药监局批准）和TCS™自稳定型颈椎融合器（该产品已获得国家药监局批准）双星闪耀COA，正式登陆中国！该技术作为全球首个获得FDA批准应用于脊柱的纳米技术，可在宏观、微米和纳米层级协同作用促进骨愈合。 Infuse™骨修复材料刚于第六届进博会完成中国大陆地区首秀的Mazor™ X Eagle鹰领脊柱外科机器人一体化平台也惊艳亮相COA学术大会。该平台可搭载美敦力先进的导航可视化高速动力磨钻系统，实现高效、安全置钉；同时实现骨性结构可视化切割。此外，新增的专用工具可提供椎间盘可视化处理，真正实现脊柱外科手术包括置钉、减压、融合等全流程的智能化与可视化辅助。荣获2023德国设计医疗及保健产品优秀设计奖的Omnail™股骨近端髓内钉也是美敦力康辉展台的"明星展品"。该创新产品由本土研发团队依据中国临床需求量身打造，现已全面上市，拥有兼容并济的植入物设计，精准易用的工具配置，充分诠释了美敦力所秉承的"全球智慧，本土创新"理念。 Mazor™ X Eagle鹰领脊柱外科机器人一体化平台 Omnail™股骨近端髓内钉立足本土，以数智骨科创新生态引领行业高质量发展数字中国、创新驱动等国家战略的持续深化，以及大数据、人工智能等技术加速迭代对骨科的数智化发展也提出了更高的要求。今年，美敦力康辉发布了"AiBLE™数智创新生态"，聚焦本土患者的需求，携手中国本土创新力量，以一体化的创新解决方案赋能医患，引领行业迈入 AI赋能、智慧联动的全病程管理时代，持续推动骨科的高质量发展。与此同时，美敦力康辉积极开展广泛的行业合作，不断丰富数智骨科一体化解决方案、扩容创新生态圈。本次COA期间，美敦力康辉和北京罗森博特科技有限公司达成重磅战略合作，共同推动数智创伤领域智能机器人系统——罗森万相®的发展与临床应用落地。罗森万相®能够帮助临床真正实现智能规划、自动操作和全程参与，未来将精准地满足日益庞大和个性化骨科诊疗需求。本次战略合作是美敦力康辉进一步完善本土生态圈的重要举措。未来，美敦力康辉将与罗森博特协手，从本土需求出发，推动疗法创新，最终惠及本土医患。美敦力康辉与北京罗森博特科技有限公司战略合作签约仪式此前，美敦力康辉已经先后与一影医疗、水木天蓬、博辉瑞进和唯医骨科等行业伙伴达成战略合作，以多元的产品组合丰富数智骨科创新解决方案，携手推进数智骨科创新生态圈的建设。此次与罗森博特的战略合作，将AiBLE™数智骨科创新生态圈拓展到创伤领域，让优质医疗服务造福更广泛的患者群体。打通产学研医，以融合创新谱写中国骨科未来近年来，美敦力康辉一方面围绕 AiBLE™数智创新生态概念持续投入本土能力建设，一方面不断探索产学研医的协同创新，积极推动医工转化，加速临床转化从0到1，助力产业转化从1到100。今年9月，美敦力康辉在常州举办了"骨科菁英会成长课堂"，邀请30位中国学术大咖，从创伤领域的临床应用和学术热点出发，深入洞察创新动机、临床转化和数字化解决方案，探索医工转化创新和实践思路，有效推动创伤领域的数智化进程。此外，美敦力康辉还积极携手生态圈伙伴打通创新成果从"有"到"用"的最后一公里。日前，美敦力康辉与北京积水潭医院就"胫骨平台技术成果转化"签署合作协议，基于此前双方合作开发的胫骨平台后外侧接骨板钉系统，进一步推动其产业化落地。 "AiBLE™数智生态是我们看见的方向，更是我们坚信的未来！" 美敦力副总裁，中国骨科与神外业务兼外科业务总经理于婧表示，"AiBLE™生态所倡导的生态理念是从产品到服务，再到产学研医及行业合作的全维生态圈。我们期待能够链接多方合作伙伴，共建一个互联互通、互相依托、相互促进的本土创新生态，全面激发中国本土创新能力，在共创共建、共生共荣的数智骨科生态中，一起推动中国骨科医疗创新的高质量发展！" [1] Medtronic BioPharma. InductOs Summary of Product Characteristics. 12/2014 [2] Liu S et al. Comparative clinical effectiveness and safety of bone morphogenetic protein versus autologous iliac crest bone graft in lumbar fusion: A meta-analysis and systematic review. Spine (Phila Pa 1976). 2020 Jun 15; 45(12): E729–E741. [3] Alt V, et al. An economic analysis of using rhBMP-2 for lumbar fusion in Germany, France and UK from a societal perspective. Eur Spine J. 2009 Jun; 18(6): 800–806.

临床研究上市批准医药出海

100 项与阿法地博特明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03779	-	M05BC01	DB11639

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
椎间盘退化	欧盟	Medtronic BioPharma BV	2002-09-09
椎间盘退化	冰岛	Medtronic BioPharma BV	2002-09-09
椎间盘退化	列支敦士登	Medtronic BioPharma BV	2002-09-09
椎间盘退化	挪威	Medtronic BioPharma BV	2002-09-09
胫骨骨折	欧盟	Medtronic BioPharma BV	2002-09-09
胫骨骨折	冰岛	Medtronic BioPharma BV	2002-09-09
胫骨骨折	列支敦士登	Medtronic BioPharma BV	2002-09-09
胫骨骨折	挪威	Medtronic BioPharma BV	2002-09-09

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨质疏松症	临床2期	美国	Pfizer Inc.	2008-12-03
骨质疏松症	临床2期	比利时	Pfizer Inc.	2008-12-03
骨质疏松症	临床2期	波兰	Pfizer Inc.	2008-12-03
骨质疏松症	临床2期	西班牙	Pfizer Inc.	2008-12-03
肱骨骨折	临床2期	美国	Wyeth AB	2007-01-01
肱骨骨折	临床2期	澳大利亚	Wyeth AB	2007-01-01
肱骨骨折	临床2期	巴西	Wyeth AB	2007-01-01
肱骨骨折	临床2期	加拿大	Wyeth AB	2007-01-01
肱骨骨折	临床2期	芬兰	Wyeth AB	2007-01-01
肱骨骨折	临床2期	法国	Wyeth AB	2007-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00752557 (CTgov)	临床2期	骨质疏松症	50	bisphosphonate+calcium (Standard of Care Control)	願築構積繭網夢淵襯憲(蓋膚顧糧觸夢願襯觸蓋) = 築範築淵顧鏇艱製鑰窪憲餘鏇蓋製範鑰壓餘簾 (遞衊齋餘選選鹽觸窪鏇, 0.018) 更多	-	2020-03-20
				rhBMP-2+CPM (rhBMP-2/CPM 1.0 mg/mL)	願築構積繭網夢淵襯憲(蓋膚顧糧觸夢願襯觸蓋) = 積膚觸艱膚築壓顧顧餘憲餘鏇蓋製範鑰壓餘簾 (遞衊齋餘選選鹽觸窪鏇, 0.045) 更多