Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts

Jong, Wim H. de; Hoffmann, Sebastian; Lee, Michelle; Kanďárová, Helena; Pellevoisin, Christian; Haishima, Yuji; Rollins, Beau; Zdawczyk, Austin; Willoughby, Jamin A.; Bachelor, Michael; Schatz, Timothy; Skoog, Shelby A.; Parker, Sherry; Sawyer, Anita; Pescio, Paolo; Fant, Kristina; Kim, Kwang Mahn; Kwon, Jae‐Sung; Gehrke, Helge; Hofman-Hüther, Hana; Méloni, Marisa; Julius, Conrad; Briotet, Damien; Letašiová, Silvia; Kato, Reiko; Miyajima, Atsuko; Fonteyne, Liset J.J. de la; Videau, Christelle; Tornier, Carine; Turley, Audrey; Christiano, Nicholas; Rollins, Thor S.; Coleman, Kelly P.

doi:10.1016/j.tiv.2018.01.001

Cited by 32 publications

(14 citation statements)

References 9 publications

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“…15 Recently, 3D tissue models have been adopted in the field of medical devices for the evaluation of potential irritation and sensitization by medical device extracts on the skin. [16][17][18] This work is the first study in which a 3D oesophageal tissue model, formed from a human cell line culture, is used for testing medical device mechanisms of action. This experimental model brings a great advantage because of the possibility of evaluating the effectiveness of different products on an organized tissue with different cell layers at the same doses used in vivo under different conditions.…”

Section: Discussionmentioning

confidence: 99%

<p>Evaluation of Human Esophageal Epithelium Permeability in Presence of Different Formulations Containing Hyaluronic Acid and Chondroitin Sulphate</p>

Pellegatta

Spadaccini

Lamonaca

et al. 2020

MDER

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New medical devices that contain hyaluronic acid (HA) and chondroitin sulphate (CS), with or without antacid components, have been developed for the treatment of gastroesophageal reflux disease (GERD) with the aim of improving oesophageal mucosal defences by creating a film on the oesophageal mucosa and acting as a mechanical barrier against the noxious components of refluxate, both acidic and basic. Methods: The film-forming and protective efficacy of medical device A based on HA and CS plus aluminium hydroxide, device B combining HA and CS with magnesium trisilicate and device C with only the combination of HA and CS was tested on a reconstructed human oesophageal epithelium (HO2E/S/5) as a biological model in 2 different pH environments, neutral and acidic, to mimic realistic conditions. Caffeine penetration kinetics and Lucifer yellow (LY) permeability modifications induced by these products were compared to those induced by a negative control series (saline solution, code NC) and positive control series (white Vaseline, code V) under neutral and acidic pH conditions. Results: Under neutral and acidic pH conditions, compared to the negative control, all the products tested reduced (>80% and 85-90%, respectively) the caffeine passage, and no significant difference was observed among the products tested. Under neutral and acidic conditions, the LY permeabilities registered with device A and device C were not different from that registered with the negative control, while an LY flux% increase was calculated after 2 hrs of treatment (21.1%) with device B under acidic conditions. Conclusion: These results confirm the ability of the products tested to interact with the oesophageal epithelium in order to adhere and create a stable protective film for at least 2 hours after their homogeneous distribution on the epithelium surface. Further clinical studies are needed to test these devices in the topical treatment of gastroesophageal reflux symptoms.

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Section: Discussionmentioning

confidence: 99%

<p>Evaluation of Human Esophageal Epithelium Permeability in Presence of Different Formulations Containing Hyaluronic Acid and Chondroitin Sulphate</p>

Pellegatta

Spadaccini

Lamonaca

et al. 2020

MDER

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“…Alternative methods and 3-D tissue models: The role of reconstructed 3-D tissues in the implementation of the 3Rs into the regulations worldwide 23). [28][29][30] Implementation of 3-D RHT models for genotoxicity and skin sensitisation testing is pending. Besides the importance of skin models for regulatory toxicity testing, the 3-D RHT models play an important role in the modern, animal-free safety and efficacy testing of ingredients and finished products by the cosmetics industry.…”

Section: Developing a 3-d Bioprinted Human Vascular Lung Model To Ide...mentioning

confidence: 99%

Advances in Animal Models and Cutting-Edge Research in Alternatives: Proceedings of the Second International Conference on 3Rs Research and Progress, Hyderabad, 2021

et al. 2022

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The fact that animal models fail to replicate human disease faithfully is now being widely accepted by researchers across the globe. As a result, they are exploring the use of alternatives to animal models. The time has come to refine our experimental practices, reduce the numbers and eventually replace the animals used in research with human-derived and human-relevant 3-D disease models. Oncoseek Bio-Acasta Health, which is an innovative biotechnology start-up company based in Hyderabad and Vishakhapatnam, India, organises an annual International Conference on 3Rs Research and Progress. In 2021, this conference was on ‘Advances in Research Animal Models and Cutting-Edge Research in Alternatives’. This annual conference is a platform that brings together eminent scientists and researchers from various parts of the world, to share recent advances from their research in the field of alternatives to animals including new approach methodologies, and to promote practices to help refine animal experiments where alternatives are not available. This report presents the proceedings of the conference, which was held in hybrid mode (i.e. virtual and in-person) in November 2021.

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“…The increasing regulatory and societal demand for alternative methods for sensitization testing is also reflected in the medical device industry. Just recently, the ISO standards have been updated to include the in vitro skin irritation test on reconstructed human tissues as predictor of intracutaneous irritation (De Jong et al, 2018;ISO, 2020). The new standard ISO 10993-23 will be published in January 2021.…”

Section: Altex Preprint Published January 26 2021 Doi:1014573/altex2008142mentioning

confidence: 99%

Sensitization potential of medical devices detected by in vitro and in vivo methods

Svobodová

Rucki

Vlková

et al. 2021

ALTEX

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Medical devices have to be tested before marketing in accordance with ISO EN 10993-10 in order to avoid skin sensitization. This standard predominantly refers to the in vivo test; however, it doesn't exclude the use of in vitro methods, which have been sufficiently technically and scientifically validated for the purpose of medical devices testing. It is foreseen that due to the complexity of the sensitization endpoint, combination of several methods will be needed to address all key events occurring in the sensitization process. The objective of this pilot study was to evaluate sensitization potential of selected medical devices using a combination of in vitro (LuSens, OECD TG 442D), in chemico (DPRA, OECD TG 442C) and in vivo (LLNA DA, OECD TG 442A) methods and to suggest a possible testing strategy for the safety assessment of medical devices extracts. Overall, one of the 42 tested samples exhibited positive results in all employed test methods, while 33 samples were predicted as samples with non-sensitizing potential in all three performed methods. This study demonstrated good agreement between in vitro and in vivo results regarding the absence of skin sensitization potential; however, discrepancies in positive classification have been recorded. The mismatch between in vitro and in vivo results might be caused by specific response of the immune system of the living organism. The in vitro methods require optimization of procedure, in particular the choice of appropriate extraction vehicle and applied volumes.

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Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts

Cited by 32 publications

References 9 publications

<p>Evaluation of Human Esophageal Epithelium Permeability in Presence of Different Formulations Containing Hyaluronic Acid and Chondroitin Sulphate</p>

<p>Evaluation of Human Esophageal Epithelium Permeability in Presence of Different Formulations Containing Hyaluronic Acid and Chondroitin Sulphate</p>

Advances in Animal Models and Cutting-Edge Research in Alternatives: Proceedings of the Second International Conference on 3Rs Research and Progress, Hyderabad, 2021

Sensitization potential of medical devices detected by in vitro and in vivo methods

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