Critical Review

Critical Issues in Successful Production of Skin Substitutes for Wound Healing

Hojjat Naderi-Meshkin , Raheleh Amirkhah, Asieh Heirani-Tabasi, Muhammad Irfan-maqsood

Hojjat Naderi-Meshkin
Iranian Academic Center for Education, Culture Research (ACECR), Khorasan Razavi Branch. Email:

Raheleh Amirkhah
Reza Institute of Cancer Bioinformatics and Personalized Medicine, Mashhad

Asieh Heirani-Tabasi
Iranian Academic Center for Education, Culture Research (ACECR), Khorasan Razavi Branch

Muhammad Irfan-maqsood
Pakistan Society for Gene and Cell Therapy
Online First: February 26, 2018 | Cite this Article
Naderi-Meshkin, H., Amirkhah, R., Heirani-Tabasi, A., Irfan-maqsood, M. 2018. Critical Issues in Successful Production of Skin Substitutes for Wound Healing. Journal of Genes and Cells 4(1): 10-32. DOI:10.15562/gnc.63

Novel findings on fabrication techniques for bioactive materials, discovering further basic knowledge about wound healing process, and availability of stem cells as alternative candidate for differentiated cells have highly encouraged scientists for developing new bioengineered skin substitutes (BSS) that offer an effective remedy for a specific wound type. However, technical, clinical, legislative and economic reasons hamper wide-spread commercialization and clinical translation of BSS. Among the various types of strategies that target skin repair and regeneration, tissue engineering with stem cells is most promising route. Tissue engineering by cooperation of several disciplines forms a context on which the commercial development of BSS is possible to provide benefits for patients who currently have limited or no cure options. The principles of tissue engineering are to initiate cell cultures in vitro, grow them in monolayer or on porous scaffolds and transplant the composite into a patient with a specific wound indication in vivo. The potential for creating of custom-designed biomaterials and availability of stem cells from either autologous or allogenic sources have helped to produce novel innovative BSS. Currently, wide range of skin substitutes are already being fabricated for clinical use in different wound indications but not yet definitively established. Therefore, many novel engineered constructs might be fabricated in the future. In this review, we describe the progress that has been made to date in the field of skin substitutes and the critical issues that are still hindering successful production and bench to bedside translation of BSS and restricting the availability of these innovative therapeutic constructs. Integrity of the science and technology, interdisciplinary expertise collaborations, and early interaction with regulatory entities such as Food and Drug Administration (FDA) and European Medicines Agency (EMA), together with other critical determinants, is vital to the successful commercialization of tissue engineering products into the marketplace/clinic.

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