School of Public Health, 3-279 Edmonton Clinic Health Academy, 11405-87 Ave, University of Alberta, Edmonton, AB, T6G 1C9, Canada.
Regen Med. 2014 Jan;9(1):27-39. doi: 10.2217/rme.13.80. Epub 2013 Nov 18.
To provide a comprehensive analysis of clinical trials (CTs) listed in worldwide registries involving new applications for stem cell-based treatments and account for the role of industry.
MATERIALS & METHODS: We developed a data set of 4749 stem cell CTs up to 2013 in worldwide registries. We defined 1058 novel CTs (i.e., trials that were not observational in nature; did not involve an established stem cell therapy for an established indication, such as hematopoietic stem cells for leukemia; and did not investigate supportive measures). Based on trial descriptions, we manually coded these for eight additional elements.
Our analysis details the characteristics of novel stem cell CTs (e.g., stem cell types being tested, disease being targeted, and whether interventions were autologous or allogeneic), geotemporal trends, and private sector involvement as sponsor or collaborator.
The field is progressing at a steady pace with emerging business models for stem cell therapeutics. However, therapeutic rhetoric must be tempered to reflect current clinical and research realities.
对全球注册处中涉及基于干细胞的新疗法新应用的临床试验（CTs）进行全面分析，并说明产业的作用。
我们建立了一个截至 2013 年的全球注册处中 4749 项干细胞 CT 的数据集。我们定义了 1058 项新 CT（即，本质上不是观察性的试验；不涉及既定的干细胞疗法针对既定的适应症，例如用于白血病的造血干细胞；也不调查支持性措施）。根据试验描述，我们手动对这些试验进行了另外八项元素的编码。
我们的分析详细说明了新的干细胞 CT 的特征（例如，正在测试的干细胞类型、目标疾病、干预措施是自体还是异体）、地理和时间趋势以及私营部门作为赞助商或合作者的参与情况。
该领域正在稳步发展，干细胞治疗的新兴商业模式正在出现。然而，治疗的言论必须加以缓和，以反映当前的临床和研究现实。
