Regenerative medicine in Obstetrics & Gynecology: Current status under the Act on the Safety of Regenerative Medicine in Japan

Autor: Satoshi Hosoya, Sena Awano-Kim, Ryo Yokomizo, Yuichiro Ukon, Kazuki Morita, Yuta Kasahara, Hiroshi Kishi, Aikou Okamoto
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Regenerative Therapy, Vol 26, Iss , Pp 564-570 (2024)
Druh dokumentu: article
ISSN: 2352-3204
DOI: 10.1016/j.reth.2024.08.003
Popis: 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
Databáze: Directory of Open Access Journals