BACKGROUND: Research on adult stem cells for the treatment of non-malignant disease grows quickly year-by-year. However,researchers are still working to identify potential indications for adult stem cells in non-malignant conditions OBJECTIVE: To provide consultative information on selecting potential indications of adult stem cells for non-malignant conditions.METHODS: On March 3rd, 2010, a search of the electronic database provided by the National Institute of Health website (http://www.clinicaltrials.gov) was conducted by using corresponding search formulas to define registered clinical research studies/trials in association with adult stem cells as an intervention in human subjects for non-malignant conditions. There was no restriction for language, research location, and research population race.RESULTS AND CONCLUSION: Of 1 540 studies identified in the initial search, 1206 malignant conditions-related studies were excluded and a further 13 studies were excluded for lack of accordance with the searching purpose. A total of 321 research studies were entered into the analysis and reviewed. Among them, about a third of the trials were for cardiocerebrovascular diseases with the majority being ischemic cardiocerebrovascular diseases; the second third were for autoimmune disorders or graft versus host diseases after organ transplantation; the remaining third were for lower limb ischemic diseases (9％ , 31/321),genetic disorders (9％, 31/321) and other diseases (22％, 73/321) of which the majority conditions were cirrhosis/hepatic failure,bone fusion operation, and type Ⅰ& Ⅱdiabetics. At present, clinical trials for adult stem cells in non-malignant diseases focus on the indications of cardiocerebrovascular diseases and peripheral vascular diseases. In addition, based on the theory of stem cells promoting tissue repair and regeneration, some of the studies were with a view to liver cirrhosis, bone fusion operation; and the idea of the immune downregulation of mesenchymal stem cells is still an important research concept.%背景:随着成体干细胞研究的深入,其在非恶性疾病中的临床适应证逐年增加;但是研究者对干细胞在非恶性疾病中临床适应证的选择上目前仍然处于探索阶段.目的:提供成体干细胞在非恶性疾病中的临床研究的方向及适应证的选择方面的参考信息.方法:2010-03-03通过互联网在美国NIH (the National Institute of Health)临床试验登记注册网站(http://www.clinicaltrials.gov),选择合适的检索式,检索成体干细胞为干预措施的在非恶性肿瘤疾病受试者中的临床研究项目.不限语言种类、研究所在地和研究人种.结果与结论:在初次检索时得到的1 540个研究项目中,排除1 206个恶性肿瘤相关研究项目和13个其他不符合检索目的的研究,共321个研究项目进入分析.其中约1/3(101)的研究与心、脑血管疾病相关,主要是缺血性心脑血管疾病.另外1/3(85)的研究项目与自身免疫性疾病或器官移植后的移植物抗宿主病(GVHD)相关.其余的1/3临床试验的适应证是下肢缺血性疾病(9%,31/321)、遗传性疾病(9%,31/321)和其他疾病(22%,73/321).在其他疾病适应证分类中,主要病种是肝硬化/肝衰竭、骨关节融合术中用及Ⅰ,Ⅱ型糖尿病等.目前,成体干细胞在非恶性肿瘤疾病中的临床研究适应证集中在心脑血管疾病和外周血管疾病.此外,基于干细胞促进组织修复/再生的理论基础,目前的一部分研究着眼于肝硬化、骨关节融合术中应用等等;间充质干细胞的免疫调节机制在免疫性疾病中的应用仍然是注册临床研究中的一个重要研究方向.
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