{"title":"根据ISO 10993指南,对自组装肽纳米纤维-纳米陶瓷仿生纳米复合材料进行了细致的生物相容性和毒理学评估。","authors":"Solmaz Chegeni, Hani Tavakol, Seyed Mahdi Rezayat, Shima Tavakol","doi":"10.1080/17435390.2025.2538479","DOIUrl":null,"url":null,"abstract":"<p><p>Bone, a complex nanocomposite, has yet to be successfully replicated in a commercially available bone regenerative product that fully recapitulates this dual-phase nanoscale architecture. This study investigated the biocompatibility and safety of a nanoalloplastic composed of spherical nanohydroxyapatite (nHA; 30-45 nm)/tricalcium phosphate (TCP) and osteogenic, angiogenic and immunomodulatory self-assembling peptide nanofibers (15-20 nm), designed to mimic the natural nanocomposite structure of bone. Adhering to ISO 10993 protocols, the nanocomposite was subjected to rigorous biocompatibility evaluation by IFDA laboratories. This assessment encompassed cytotoxicity, genotoxicity, hemocompatibility, sensitization, and irritation, as well as acute and chronic systemic toxicity studies. Results demonstrated the material's non-cytotoxic nature, with no significant reduction in cell viability. Hemocompatibility testing revealed acceptable hemolytic activity, while genotoxicity assays showed no evidence of DNA damage. Neither irritation nor sensitization was observed. Systemic toxicity studies in mice revealed no adverse clinical signs, weight changes, or organ pathologies. Bone regeneration study showed complete and osteoinductive potential over one month in rabbits. The peptide nanofibers contribute to the material's biocompatibility through their ECM-mimicking sequences, nanofibrous architecture, biodegradability, and toxic- and solvent-free nature. TCP and spherical nHA with an optimum particle size, morphology, crystallinity, dissolution rate, and significant pH stability, collectively ensure its biocompatibility and vascularized bone formation. These findings validate the biocompatibility and safety of this osteoinductive nanocomposite. The integration of spherical nHA and self-assembling peptide nanofibers appears to generate a biomimetic microenvironment that improves cellular interactions, thereby accelerating bone regeneration and confirming its biocompatibility, positioning it as a revolutionary solution for bone regeneration.</p>","PeriodicalId":18899,"journal":{"name":"Nanotoxicology","volume":" ","pages":"489-507"},"PeriodicalIF":3.4000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A meticulous biocompatibility and toxicological assessment of a self-assembling peptide nanofiber-nanoceramic biomimetic nanocomposite, per ISO 10993 guidelines.\",\"authors\":\"Solmaz Chegeni, Hani Tavakol, Seyed Mahdi Rezayat, Shima Tavakol\",\"doi\":\"10.1080/17435390.2025.2538479\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Bone, a complex nanocomposite, has yet to be successfully replicated in a commercially available bone regenerative product that fully recapitulates this dual-phase nanoscale architecture. This study investigated the biocompatibility and safety of a nanoalloplastic composed of spherical nanohydroxyapatite (nHA; 30-45 nm)/tricalcium phosphate (TCP) and osteogenic, angiogenic and immunomodulatory self-assembling peptide nanofibers (15-20 nm), designed to mimic the natural nanocomposite structure of bone. Adhering to ISO 10993 protocols, the nanocomposite was subjected to rigorous biocompatibility evaluation by IFDA laboratories. This assessment encompassed cytotoxicity, genotoxicity, hemocompatibility, sensitization, and irritation, as well as acute and chronic systemic toxicity studies. Results demonstrated the material's non-cytotoxic nature, with no significant reduction in cell viability. Hemocompatibility testing revealed acceptable hemolytic activity, while genotoxicity assays showed no evidence of DNA damage. Neither irritation nor sensitization was observed. Systemic toxicity studies in mice revealed no adverse clinical signs, weight changes, or organ pathologies. Bone regeneration study showed complete and osteoinductive potential over one month in rabbits. The peptide nanofibers contribute to the material's biocompatibility through their ECM-mimicking sequences, nanofibrous architecture, biodegradability, and toxic- and solvent-free nature. TCP and spherical nHA with an optimum particle size, morphology, crystallinity, dissolution rate, and significant pH stability, collectively ensure its biocompatibility and vascularized bone formation. These findings validate the biocompatibility and safety of this osteoinductive nanocomposite. The integration of spherical nHA and self-assembling peptide nanofibers appears to generate a biomimetic microenvironment that improves cellular interactions, thereby accelerating bone regeneration and confirming its biocompatibility, positioning it as a revolutionary solution for bone regeneration.</p>\",\"PeriodicalId\":18899,\"journal\":{\"name\":\"Nanotoxicology\",\"volume\":\" \",\"pages\":\"489-507\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nanotoxicology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/17435390.2025.2538479\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"NANOSCIENCE & NANOTECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nanotoxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17435390.2025.2538479","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"NANOSCIENCE & NANOTECHNOLOGY","Score":null,"Total":0}
A meticulous biocompatibility and toxicological assessment of a self-assembling peptide nanofiber-nanoceramic biomimetic nanocomposite, per ISO 10993 guidelines.
Bone, a complex nanocomposite, has yet to be successfully replicated in a commercially available bone regenerative product that fully recapitulates this dual-phase nanoscale architecture. This study investigated the biocompatibility and safety of a nanoalloplastic composed of spherical nanohydroxyapatite (nHA; 30-45 nm)/tricalcium phosphate (TCP) and osteogenic, angiogenic and immunomodulatory self-assembling peptide nanofibers (15-20 nm), designed to mimic the natural nanocomposite structure of bone. Adhering to ISO 10993 protocols, the nanocomposite was subjected to rigorous biocompatibility evaluation by IFDA laboratories. This assessment encompassed cytotoxicity, genotoxicity, hemocompatibility, sensitization, and irritation, as well as acute and chronic systemic toxicity studies. Results demonstrated the material's non-cytotoxic nature, with no significant reduction in cell viability. Hemocompatibility testing revealed acceptable hemolytic activity, while genotoxicity assays showed no evidence of DNA damage. Neither irritation nor sensitization was observed. Systemic toxicity studies in mice revealed no adverse clinical signs, weight changes, or organ pathologies. Bone regeneration study showed complete and osteoinductive potential over one month in rabbits. The peptide nanofibers contribute to the material's biocompatibility through their ECM-mimicking sequences, nanofibrous architecture, biodegradability, and toxic- and solvent-free nature. TCP and spherical nHA with an optimum particle size, morphology, crystallinity, dissolution rate, and significant pH stability, collectively ensure its biocompatibility and vascularized bone formation. These findings validate the biocompatibility and safety of this osteoinductive nanocomposite. The integration of spherical nHA and self-assembling peptide nanofibers appears to generate a biomimetic microenvironment that improves cellular interactions, thereby accelerating bone regeneration and confirming its biocompatibility, positioning it as a revolutionary solution for bone regeneration.
期刊介绍:
Nanotoxicology invites contributions addressing research relating to the potential for human and environmental exposure, hazard and risk associated with the use and development of nano-structured materials. In this context, the term nano-structured materials has a broad definition, including ‘materials with at least one dimension in the nanometer size range’. These nanomaterials range from nanoparticles and nanomedicines, to nano-surfaces of larger materials and composite materials. The range of nanomaterials in use and under development is extremely diverse, so this journal includes a range of materials generated for purposeful delivery into the body (food, medicines, diagnostics and prosthetics), to consumer products (e.g. paints, cosmetics, electronics and clothing), and particles designed for environmental applications (e.g. remediation). It is the nano-size range if these materials which unifies them and defines the scope of Nanotoxicology .
While the term ‘toxicology’ indicates risk, the journal Nanotoxicology also aims to encompass studies that enhance safety during the production, use and disposal of nanomaterials. Well-controlled studies demonstrating a lack of exposure, hazard or risk associated with nanomaterials, or studies aiming to improve biocompatibility are welcomed and encouraged, as such studies will lead to an advancement of nanotechnology. Furthermore, many nanoparticles are developed with the intention to improve human health (e.g. antimicrobial agents), and again, such articles are encouraged. In order to promote quality, Nanotoxicology will prioritise publications that have demonstrated characterisation of the nanomaterials investigated.