{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T19:15:30Z","timestamp":1779909330125,"version":"3.53.1"},"reference-count":60,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2023,5,24]],"date-time":"2023-05-24T00:00:00Z","timestamp":1684886400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Universiti Kebangsaan Malaysia","award":["UKM-TR-006"],"award-info":[{"award-number":["UKM-TR-006"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Polymers"],"abstract":"<jats:p>Wound care management is incredibly challenging for chronic injuries, despite the availability of various types of wound care products in the market. However, most current wound-healing products do not attempt to mimic the extracellular matrix (ECM) and simply provide a barrier function or wound covering. Collagen is a natural polymer that involves a major constituent of the ECM protein, thus making it attractive to be used in skin tissue regeneration during wound healing. This study aimed to validate the biological safety assessments of ovine tendon collagen type-I (OTC-I) in the accredited laboratory under ISO and GLP settings. It is important to ensure that the biomatrix will not stimulate the immune system to produce any adverse reaction. Therefore, we successfully extracted collagen type-I from the ovine tendon (OTC- I) using a method of low-concentration acetic acid. The three-dimensional (3D) skin patch of spongy OTC-I was a soft and white colour, being tested for safety and biocompatibility evaluations based on ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23, USP 40 &lt;151&gt;, and OECD 471. For the dermal sensitisation and acute irritation test, none of the tested animals displayed any erythema or oedema effects (p &gt; 0.005). In addition, there were no abnormalities detected in the organ of the mice after being exposed to OTC-I; additionally, no morbidity and mortality were observed in the acute systemic test under the guideline of ISO 10993-11:2017. The grade 0 (non-reactive) based on ISO 10993-5:2009 was graded for the OTC-I at 100% concentration and the mean number of the revertant colonies did not exceed 2-fold of the 0.9% w\/v sodium chloride compared to the tester strains of S. typhimurium (TA100, TA1535, TA98, TA1537), and E. coli (WP2 trp uvrA). Our study revealed that OTC-I biomatrix does not present any adverse effects or abnormalities in the present study\u2019s condition of induced skin sensitization effect, mutagenic and cytotoxic towards cells and animals. This biocompatibility assessment demonstrated a good agreement between in vitro and in vivo results regarding the absence of skin irritation and sensitization potential. Therefore, OTC-I biomatrix is a potential medical device candidate for future clinical trials focusing on wound care management.<\/jats:p>","DOI":"10.3390\/polym15112436","type":"journal-article","created":{"date-parts":[[2023,5,25]],"date-time":"2023-05-25T02:00:55Z","timestamp":1684980055000},"page":"2436","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Biological Safety Assessments of High-Purified Ovine Collagen Type I Biomatrix for Future Therapeutic Product: International Organisation for Standardisation (ISO) and Good Laboratory Practice (GLP) Settings"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8991-1828","authenticated-orcid":false,"given":"Nur Izzah Md","family":"Fadilah","sequence":"first","affiliation":[{"name":"Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1377-4198","authenticated-orcid":false,"given":"Nazeha","family":"Ahmat","sequence":"additional","affiliation":[{"name":"Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Looi Qi","family":"Hao","sequence":"additional","affiliation":[{"name":"Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia"},{"name":"My Cytohealth Sdn. Bhd., Kuala Lumpur 56000, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2154-7852","authenticated-orcid":false,"given":"Manira","family":"Maarof","sequence":"additional","affiliation":[{"name":"Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9124-0605","authenticated-orcid":false,"given":"Nor Fadilah","family":"Rajab","sequence":"additional","affiliation":[{"name":"Biomedical Science Program, Center for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abd Aziz, Kuala Lumpur 50300, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruszymah Binti Hj","family":"Idrus","sequence":"additional","affiliation":[{"name":"Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6449-639X","authenticated-orcid":false,"given":"Mh Busra","family":"Fauzi","sequence":"additional","affiliation":[{"name":"Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia"},{"name":"My Cytohealth Sdn. Bhd., Kuala Lumpur 56000, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,5,24]]},"reference":[{"key":"ref_1","unstructured":"(2022). Malaysia Advanced Wound Care Market Size By Product, Verified Market Research."},{"key":"ref_2","first-page":"34","article-title":"A patented formulation of SiO2\u2212+ Ag+ + Chlorhexidine + Hyaluronic acid","volume":"2","author":"Harikrishna","year":"2019","journal-title":"Wounds Asia"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"104981","DOI":"10.1016\/j.jff.2022.104981","article-title":"Bovine collagen oligopeptides accelerate wound healing by promoting fibroblast migration via PI3K\/Akt\/mTOR signaling pathway","volume":"90","author":"Bao","year":"2022","journal-title":"J. Funct. 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