Negoro Takaharu, Takagaki Yuri, Okura Hanayuki, Matsuyama Akifumi
1Department of Regenerative Medicine Support Promotion Facility, Center for Research Promotion and Support, Fujita Health University, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192 Japan.
2Office of Policy and Ethics Research, National Institutes of Biomedical Innovation, Health and Nutrition, 7-6-8, Saito Asagi, Osaka, Ibaraki 567-0085 Japan.
NPJ Regen Med. 2018 Oct 11;3:17. doi: 10.1038/s41536-018-0055-2. eCollection 2018.
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.
关节软骨的局灶性和退行性病变会大大降低患者的生活质量。包括手术治疗在内的各种治疗方法已被开发出来,但尚未有确定的治疗方法。几种细胞治疗产品已经研发出来并投放市场。在本研究中,我们根据从ClinicalTrial.gov网站获取的数据,研究了软骨修复领域中与细胞治疗产品相关的临床研究趋势。虽然该网站不提供临床试验的全面结果,但它提供了前瞻性临床试验的信息,包括正在进行的研究,从而可以对数据进行时间顺序分析。我们从ClinicalTrial.gov网站上选择了203项与软骨再生领域相关的研究。结果显示,在临床转化趋势方面,所使用的细胞已从软骨和骨髓来源的细胞转向脂肪组织来源的细胞。以软骨为细胞来源的研究包括许多III期试验,而使用骨髓和脂肪组织细胞的研究进入III期的较少,这表明目前大多数使用后两种来源的临床研究尚未成功。有一种产品涵盖了从I期开始到III期完成的整个阶段,完成时间超过100个月。我们还讨论了自体软骨细胞植入的转化趋势。将ClinicalTrials.gov作为唯一数据源能够呈现全球临床转化趋势的全景,而这在以往是很难观察到的。