Vascular Biology and Therapeutics Program and Department of Surgery , Yale School of Medicine, Yale University, New Haven, CT, USA.
Faculty of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil.
Stem Cell Res Ther. 2018 Jul 11;9(1):188. doi: 10.1186/s13287-018-0938-6.
Diabetic foot ulcer (DFU) is a severe complication of diabetes, preceding most diabetes-related amputations. DFUs require over US$9 billion for yearly treatment and are now a global public health issue. DFU occurs in the setting of ischemia, infection, neuropathy, and metabolic disorders that result in poor wound healing and poor treatment options. Recently, stem cell therapy has emerged as a new interventional strategy to treat DFU and appears to be safe and effective in both preclinical and clinical trials. However, variability in the stem cell type and origin, route and protocol for administration, and concomitant use of angioplasty confound easy interpretation and generalization of the results.
The PubMed, Google Scholar, and EMBASE databases were searched and 89 preclinical and clinical studies were selected for analysis.
There was divergence between preclinical and clinical studies regarding stem cell type, origin, and delivery techniques. There was heterogeneous preclinical and clinical study design and few randomized clinical trials. Granulocyte-colony stimulating factor was employed in some studies but with differing protocols. Concomitant performance of angioplasty with stem cell therapy showed increased efficiency compared to either therapy alone.
Stem cell therapy is an effective treatment for diabetic foot ulcers and is currently used as an alternative to amputation for some patients without other options for revascularization. Concordance between preclinical and clinical studies may help design future randomized clinical trials.
糖尿病足溃疡(DFU)是糖尿病的严重并发症,是大多数与糖尿病相关的截肢的前兆。DFU 每年的治疗费用超过 90 亿美元,现已成为全球公共卫生问题。DFU 发生在缺血、感染、神经病变和代谢紊乱的情况下,导致伤口愈合不良和治疗选择有限。最近,干细胞疗法已成为治疗 DFU 的一种新的介入策略,在临床前和临床试验中均显示出安全性和有效性。然而,干细胞类型和来源、给药途径和方案以及与血管成形术的同时使用存在差异,这使得对结果的解释和推广变得复杂。
检索了 PubMed、Google Scholar 和 EMBASE 数据库,并选择了 89 项临床前和临床研究进行分析。
临床前和临床研究在干细胞类型、来源和输送技术方面存在差异。临床前和临床研究设计存在异质性,且随机临床试验较少。一些研究中使用了粒细胞集落刺激因子,但方案不同。与单独进行干细胞疗法相比,与血管成形术同时进行显示出更高的效率。
干细胞疗法是治疗糖尿病足溃疡的有效方法,目前已被用作某些无其他血运重建选择的患者的截肢替代方法。临床前和临床研究之间的一致性可能有助于设计未来的随机临床试验。