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

20251 citationsReviewgold Open Access

Authors

Masao Sasai · Japan Society for the Promotion of Science

Yayoi Kitawaki · Novartis (Japan)

Akihiro Umezawa · National Center For Child Health and Development

Yoshinori Oie · Osaka City University

Takahiro Kamiya · Institute of Science Tokyo

Takuji Kawamura · Osaka City University

Yoji Sato

Abstract

This study reviewed the compassionate use systems for OOS products in Japan, the United States, and Europe, highlighting current challenges and proposing a sustainable regulatory framework for future practice.

Topics & Keywords

Pluripotent Stem Cells Research Biomedical Ethics and Regulation Organ and Tissue Transplantation Research

UN Sustainable Development Goals

Zero hunger

Publication Details

Published in: Stem Cell Research & Therapy

Volume 16, Issue 1, pp. 238-238

DOI: 10.1186/s13287-025-04343-0

Field-Weighted Citation Impact: 0.84