Challenges and opportunities in the compassionate use of out-of-specification products in autologous regenerative medicine

Abstract Background In recent years, therapeutic preparations using patient-derived tissues have emerged as commercially approved regenerative medicine products for expanding treatment possibilities for patients with no other treatment options. Autologous cell-processed products, derived from the ti...

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Main Authors:	Masao Sasai, Yayoi Kitawaki, Akihiro Umezawa, Yoshinori Oie, Takahiro Kamiya, Takuji Kawamura, Yoji Sato, Satoshi Hosoya, Hiroyuki Sugawara, Kazuto Yamada, Hiroshi Izumoto, Yoshiyuki Mae, Tohru Kuroda, Kiyoshi Okada
Format:	Article
Language:	English
Published:	BMC 2025-05-01
Series:	Stem Cell Research & Therapy
Subjects:	Out-of-specification product Autologous regenerative medicine Clinical trial Good manufacturing practice Expanded access program Compassionate use,
Online Access:	https://doi.org/10.1186/s13287-025-04343-0
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Challenges and opportunities in the compassionate use of out-of-specification products in autologous regenerative medicine

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