Hosoya Satoshi, Awano-Kim Sena, Yokomizo Ryo, Ukon Yuichiro, Morita Kazuki, Kasahara Yuta, Kishi Hiroshi, Okamoto Aikou
Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 3-25-8, Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan.
Department of Orthopaedic Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
Regen Ther. 2024 Aug 13;26:564-570. doi: 10.1016/j.reth.2024.08.003. eCollection 2024 Jun.
While the provision of unapproved regenerative medicine has been problematic worldwide, few studies have examined the implementation status of regenerative medicine (RM) in the specific field. This study aimed to determine the current status of therapy and clinical research in the obstetrics and gynecology (OBGYN) in Japan under the Act on the Safety of Regenerative Medicine (RM Act).
Detailed data were extracted from publicly available websites provided by the Ministry of Health, Labour, and Welfare. We extracted descriptive details, including risk classification of the RM Act, modality, target disease, locality, institution, and administration route. For therapy, the price for each modality was evaluated.
The total number of therapeutic provision plans in OBGYN (1.9% of RM in Japan) are classified as Class II (moderate) risk. Most were administered in clinics in urban areas for treating endometrial or ovarian infertility by locally administering platelet-rich plasma (PRP) or autologous mesenchymal stem cells (MSCs). The price using MSCs is approximately eight times more expensive that of those involving PRP (1832.1 ± 1139.8 vs 240.8 ± 106.5 thousand yen, p < 0.0001). Regarding research, four plans (2.2%) were submitted to target implantation failure and advanced gynecological cancer using autologous lymphocytes, dendritic cells, or MSCs.
The RM Act permits knowledge of the current status of regenerative medicine even for unapproved uses in a specific clinical field. The study findings shall prompt a worldwide discussion regarding the required regulations for therapy and clinical research of RM.
虽然提供未经批准的再生医学在全球范围内都存在问题，但很少有研究考察再生医学在特定领域的实施状况。本研究旨在根据《再生医学安全法》（《再生医学法》）确定日本妇产科领域再生医学治疗及临床研究的现状。
从厚生劳动省提供的公开网站提取详细数据。我们提取了描述性细节，包括《再生医学法》的风险分类、治疗方式、目标疾病、地区、机构及给药途径。对于治疗，评估了每种治疗方式的价格。
妇产科的治疗提供计划总数（占日本再生医学的1.9%）被归类为II类（中度）风险。大多数在城市地区的诊所进行，通过局部注射富血小板血浆（PRP）或自体间充质干细胞（MSC）治疗子宫内膜或卵巢性不孕症。使用MSC的价格约为使用PRP的八倍（1832.1±1139.8对240.8±106.5千日元，p<0.0001）。关于研究，有四项计划（2.2%）提交，目标是使用自体淋巴细胞、树突状细胞或MSC治疗植入失败和晚期妇科癌症。
《再生医学法》即使对于特定临床领域中未经批准的用途，也能让人了解再生医学的现状。研究结果将促使全球范围内对再生医学治疗和临床研究所需法规展开讨论。
