Negoro-Cartilage_processed data.xlsx

Focal and degenerative lesions of articular cartilage greatly reduce the patient’s quality of life. Various therapies including surgical treatment have been developed, but a definitive therapy is not yet known. Several cell therapy products have already been developed and are available in the market. In this study, we examined the clinical research trends related to cell therapy products in the cartilage repair field based on data obtained from the ClinicalTrial.gov website. Although this website does not provide comprehensive results of clinical trials, it offers information on prospective clinical trials, including work in progress, and thus allows for chronological analysis of the data. We selected 203 studies related to the field of cartilage regeneration from ClinicalTrial.gov. The results showed a shift in the clinical translational trend in utilized cells from cartilage- and bone marrow- to adipose tissue-based cells. Whereas the studies that used cartilage as the cell source included many Phase III trials, fewer studies using bone marrow and adipose tissue cells progressed to Phase III, suggesting that most clinical developments using the latter sources have not been successful so far. One product covered the entire period from the start of Phase I to the completion of Phase III, with a time to completion of more than 100 months. Translational trends in autologous chondrocyte implantation were also discussed. The use of ClinicalTrials.gov as the sole data source can yield a perspective view of the global clinical translational trends, which has been difficult to observe up to this point.

关节软骨（articular cartilage）局灶性退行性病变会显著降低患者的生活质量。目前已开发包括外科治疗在内的多种疗法，但尚未确立确定性治疗方案。多款细胞治疗产品（cell therapy products）已完成研发并投入市场。本研究基于美国临床试验数据库（ClinicalTrial.gov）获取的数据，对软骨修复领域细胞治疗产品相关的临床研究趋势进行分析。尽管该数据库并未涵盖所有临床试验的完整结果，但其收录了包括正在进行中的研究在内的前瞻性临床试验信息，因此可实现数据的时序化分析。我们从该数据库中筛选出203项与软骨再生领域相关的研究。结果显示，临床转化研究中所使用的细胞来源已从软骨源性、骨髓源性向脂肪源性转变。以软骨作为细胞来源的研究中，III期临床试验占比颇高；而采用骨髓及脂肪组织来源细胞的研究进展至III期阶段的比例较低，这表明依托后两类细胞来源的多数临床研发项目迄今尚未取得成功。有一款产品完成了从I期临床试验启动到III期试验结束的全流程，耗时超过100个月。本研究还探讨了自体软骨细胞移植（autologous chondrocyte implantation）的临床转化趋势。仅以ClinicalTrial.gov作为单一数据源，即可获取此前难以观测到的全球临床转化趋势全景，这一视角为既往研究所匮乏。