Bringing hydrogel-based craniofacial therapies to the clinic.
Bringing hydrogel-based craniofacial therapies to the clinic.
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DOI：
10.1016/j.actbio.2021.10.056
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发表时间：
2022-01-15
影响因子：
9.7
通讯作者：
Harrington, Daniel A.
中科院分区：
文献类型：
--
作者：
Trubelja, Alen;Kasper, F. Kurtis;Farach-Carson, Mary C.;Harrington, Daniel A.
关键词：
这篇综述探讨了水凝胶在颅面软组织工程中应用的演变，从非细胞可注射填料到具有复杂成分和结构的预制细胞负载结构的复杂性。讨论了原位和离体方法，创伤或肿瘤切除后的组织恢复。从相对简单的口腔黏膜和牙龈上皮开始，然后转移到更功能的单位，如声带或具有多层分支结构的软组织，如唾液腺，受到天然组织组织的启发，提出了各种方法来设计功能驱动的结构。这里提出了多种组织替代范例，包括水凝胶作为结构材料和作为细胞和/或疗法的递送平台的应用。基于水凝胶系统的材料和细胞复杂性、空间顺序和生物货物，提出了颅面应用水凝胶系统的实用层次。这种层次结构反映了美国食品和药物管理局（FDA）在这些系统商业化用于人类之前规定的监管复杂性。各种可用的生物制造方法，从简单的注射器挤出生物材料到用于复杂结构的基于光的空间模式，都被认为是fda批准的商业疗法的历史。最后，综述评估了这些调控途径对颅面应用的临床前技术转化潜力的影响。虽然许多市售的基于水凝胶的产品用于颅面区域，但大多数都是简单的配方，用于局部应用或注射到组织中以达到美观目的。学术文献概述了许多令人兴奋的应用，利用水凝胶的多功能性进行颅面软组织工程。该领域最令人兴奋的发展之一是先进生物制造方法的出现，用于设计复杂的水凝胶系统，可以促进组织的功能或结构修复。迄今为止，没有临床可用的基于水凝胶的治疗充分利用了目前的临床前进展。这篇综述调查了目前可用的临床治疗方法日益复杂的现状，并提出了未来扩大水凝胶使用的框架，着眼于可翻译性和美国监管机构批准颅面应用。
This review explores the evolution of the use of hydrogels for craniofacial soft tissue engineering, ranging in complexity from acellular injectable fillers to fabricated, cell-laden constructs with complex compositions and architectures. Addressing both in situ and ex vivo approaches, tissue restoration secondary to trauma or tumor resection is discussed. Beginning with relatively simple epithelia of oral mucosa and gingiva, then moving to more functional units like vocal cords or soft tissues with multilayer branched structures, such as salivary glands, various approaches are presented toward the design of function-driven architectures, inspired by native tissue organization. Multiple tissue replacement paradigms are presented here, including the application of hydrogels as structural materials and as delivery platforms for cells and/or therapeutics. A practical hierarchy is proposed for hydrogel systems in craniofacial applications, based on their material and cellular complexity, spatial order, and biological cargo(s). This hierarchy reflects the regulatory complexity dictated by the Food and Drug Administration (FDA) in the United States prior to commercialization of these systems for use in humans. The wide array of available biofabrication methods, ranging from simple syringe extrusion of a biomaterial to light-based spatial patterning for complex architectures, is considered within the history of FDA-approved commercial therapies. Lastly, the review assesses the impact of these regulatory pathways on the translational potential of promising pre-clinical technologies for craniofacial applications. While many commercially available hydrogel-based products are in use for the craniofacial region, most are simple formulations that either are applied topically or injected into tissue for aesthetic purposes. The academic literature previews many exciting applications that harness the versatility of hydrogels for craniofacial soft tissue engineering. One of the most exciting developments in the field is the emergence of advanced biofabrication methods to design complex hydrogels systems that can promote the functional or structural repair of tissues. To date, no clinically available hydrogel-based therapy takes full advantage of current pre-clinical advances. This review surveys the increasing complexity of the current landscape of available clinical therapies and presents a framework for future expanded use of hydrogels with an eye toward translatability and U.S. regulatory approval for craniofacial applications.
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