Gurtner Geoffrey C, Chapman Mary Ann
Stanford University School of Medicine , Stanford, California.
TTC Group , Huntington, New York.
Adv Wound Care (New Rochelle). 2016 Jul 1;5(7):314-328. doi: 10.1089/wound.2015.0663.
Chronic wounds are a prevalent and costly problem in the United States. Improved treatments are needed to heal these wounds and prevent serious complications such as infection and amputation. In wound healing, as in other areas of medicine, technologies that have the potential to regenerate as opposed to repair tissue are gaining ground. These include customizable nanofiber matrices incorporating novel materials; a variety of autologous and allogeneic cell types at various stages of differentiation (, pluripotent, terminally differentiated); peptides; proteins; small molecules; RNA inhibitors; and gene therapies. Wound healing is a logical target for regenerative medicine due to the accessibility and structure of skin, the regenerative nature of healing, the lack of good limb salvage treatments, and the current use of cell therapies. However, more extensive knowledge of pathophysiologic targets is needed to inform regenerative strategies, and new technologies must demonstrate value in terms of outcomes and related health economic measures to achieve successful market access and penetration. Due to similarities in cell pathways and developmental mechanisms, regenerative technologies developed in one therapeutic area may be applicable to others. Approaches that proceed from human genomic or other big data sources to models are becoming increasingly common and will likely suggest novel therapeutic avenues. To fully capitalize on the advances in regenerative medicine, studies must demonstrate the value of new therapies in identified patient populations, and sponsors must work with regulatory agencies to develop appropriate dossiers supporting timely approval.
慢性伤口在美国是一个普遍且代价高昂的问题。需要改进治疗方法来治愈这些伤口，并预防诸如感染和截肢等严重并发症。在伤口愈合方面，与医学的其他领域一样，具有组织再生而非修复潜力的技术正在兴起。这些技术包括包含新型材料的可定制纳米纤维基质；处于不同分化阶段（多能、终末分化）的多种自体和异体细胞类型；肽；蛋白质；小分子；RNA抑制剂；以及基因疗法。由于皮肤的可及性和结构、愈合的再生性质、缺乏良好的肢体挽救治疗方法以及当前细胞疗法的应用，伤口愈合是再生医学的一个合理目标。然而，需要更广泛地了解病理生理靶点，以为再生策略提供依据，并且新技术必须在结果和相关卫生经济指标方面证明其价值，才能成功进入市场并实现市场渗透。由于细胞途径和发育机制存在相似性，在一个治疗领域开发的再生技术可能适用于其他领域。从人类基因组或其他大数据源发展到模型的方法越来越普遍，并且可能会提出新的治疗途径。为了充分利用再生医学的进展，研究必须证明新疗法在特定患者群体中的价值，并且申办者必须与监管机构合作，制定适当的档案以支持及时获批。
