1. Regenerative medicine in Obstetrics & Gynecology: Current status under the Act on the Safety of Regenerative Medicine in Japan
- Author
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Satoshi Hosoya, Sena Awano-Kim, Ryo Yokomizo, Yuichirou Ukon, Kazuki Morita, Yuta Kasahara, Hiroshi Kishi, and Aikou Okamoto
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Regenerative medicine ,Act on the Safety of Regenerative Medicine ,Cellular therapy ,Obstetrics and Gynecology ,Japan ,Private practice ,Medicine (General) ,R5-920 ,Cytology ,QH573-671 - Abstract
Introduction: 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). Methods: 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. Results: 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
- Published
- 2024
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