Evaluation of Cytotoxicity and Genotoxicity af An Intra-Articular Hyaluronic Acid Gel Implant by Some In Vitro Biocompatibility Tests.

Öz

The first step in testing the biocompatibility of medical devices is cytotoxicity testing. Genotoxicity tests, another important aspect of biocompatibility risk assessment, are also performed to analyze carcinogenic, mutagenic, and genital toxicity. Subjecting medical devices to a series of tests, such as cytotoxicity and genotoxicity tests, before clinical use is a necessity for both risk assessment and the licensing process. In this study, the cytotoxicity of a newly produced commercial medical device based on hyaluronic acid was evaluated using MTT and agar diffusion tests, and its genotoxicity was evaluated using the in vitro micronucleus test. In the MTT test, cell viability at a 1:1 concentration was 52.41% and 3.44%, indicating that the sample was cytotoxic. In the agar diffusion test, there was no reaction in the cells to which the sample was applied, and the result was grade=0, indicating that it was not cytotoxic. In the in vitro micronucleus test, statistical calculations showed that the sample was not genotoxic. Direct cytotoxicity testing of viscous/gel-like samples may lead to false positive or false negative results. Therefore, when selecting tests and evaluating results, it is recommended to consider the physical and chemical properties of the sample and to apply both direct and indirect cytotoxicity tests when necessary. In conclusion, to accurately evaluate the results of biocompatibility tests, tests appropriate to the sample must be selected.

Anahtar Kelimeler

• Biocompatibility
• cytotoxicity
• genotoxicity
• hyaluronic acid gel.

Etik Beyan

This research was conducted in accordance with research and publication ethics. Since this article does not involve any studies with human or animal subjects and is based on a literature review and analysis, approval from an ethics committee is not required.

Teşekkür

A portion of this study was presented as a poster at the MEDECO National Medical Device and Biocompatibility Congress. We would like to thank Kırıkkale University Scientific and Technological Research Application and Research Center for their contributions.

Bir İntra Artiküler Hiyalüronik Asit Jel İmplantın Bazı İn Vitro Biyouyumluluk Testleri ile Sitotoksisitesinin ve Genotoksisitesinin Değerlendirilmesi

Öz

Tıbbi cihazların biyouyumluluğunu test etmenin ilk adımı sitotoksisite testidir. Biyouyumluluk risk değerlendirmesinin önemli bir ayağı olan genotoksisite testleri de karsinojenite, mutajenite ve genital toksisiteyi analiz etmek için yapılır. Tıbbi cihazların klinik kullanım öncesinde biyouyumluluk testlerine tabii tutulması hem risk değerlendirmesi hem de ruhsatlandırma süreci için bir zorunluluktur. Bu çalışmada, hiyalüronik asit bazlı yeni üretilen ticari bir tıbbi cihazın MTT testi ve agar difüzyon testleri ile sitotoksisitesi, in vitro mikronükleus testi ile de genotoksisitesi değerlendirildi. MTT testinde 1/1 konsantrasyonda hücre canlılığı %52,41 ± 3,44 olup numune sitotoksik olarak değerlendiridi. Agar difüzyon testinde ise numunenin uygulandığı hücrelerde reaksiyon yok ve derece=0 sonucuyla sitotoksik olmadığı belirlendi. İn vitro mikronükleus testinde ise istatistiksel hesaplamalar sonucunda numunenin genotoksik olmadığı gözlendi. Bu çalışma, sitotoksisite testlerinin sonuçlarında bir farklılık olduğunu göstermektedir. Bu farklılığın nedenleri, jel benzeri test örneğinin kimyasal bileşiminden ziyade fiziksel özelliklerinin, test ortamındaki hücre davranışını ve hücre zarının yüzey özelliklerini etkilemesinden kaynaklanmaktadır. Bu nedenle, biyouyumluluk testleri seçilirken ve sonuçlar değerlendirilirken, test örneğinin fiziksel ve kimyasal özelliklerinin dikkate alınması ve gerektiğinde hem doğrudan hem de dolaylı sitotoksisite testleri yapılarak örnek için uygun testlerin seçilmesi önerilir.

Anahtar Kelimeler

• Biyouyumluluk
• sitotoksisite
• genotoksisite
• hiyalüronik asit

Etik Beyan

Bu araştırma, araştırma ve yayınlama etiğine uygun bir şekilde yürütülmüştür. Bu makalede insan veya hayvan deneklerle herhangi bir çalışma bulunmaması ve literatür analizi ile incelemeye dayalı olarak yapıldığından etik kurul kararı zorunluluğu bulunmamaktadır.

Teşekkür

Bu çalışmanın bir bölümü MEDECO Ulusal Tıbbi Cihaz ve Biyouyumluluk Kongresi'nde poster olarak sunulmuştur. Katkılarından dolayı Kırıkkale Üniversitesi Bilimsel ve Teknolojik Araştırma Uygulama ve Araştırma Merkezi'ne teşekkür ederiz.

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