Recommendations for the safe implementation of intravenous administration of mesenchymal stromal cells

Mesenchymal stromal cells (MSCs) are immunosuppressive, inflammation-reducing, and fibrosis-modifying cells that are currently being used for a variety of diseases. In this context, the transvenous administration of MSCs must be performed correctly under controlled standards. To support clinical pra...

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Main Authors: Shuji Terai, Sachiko Ezoe, Kyosuke Mano, Yumi Matsuzaki, Yoji Sato, Kenichi Yamahara, Hideyuki Okano
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Regenerative Therapy
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Online Access:http://www.sciencedirect.com/science/article/pii/S2352320425000240
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author Shuji Terai
Sachiko Ezoe
Kyosuke Mano
Yumi Matsuzaki
Yoji Sato
Kenichi Yamahara
Hideyuki Okano
author_facet Shuji Terai
Sachiko Ezoe
Kyosuke Mano
Yumi Matsuzaki
Yoji Sato
Kenichi Yamahara
Hideyuki Okano
author_sort Shuji Terai
collection DOAJ
description Mesenchymal stromal cells (MSCs) are immunosuppressive, inflammation-reducing, and fibrosis-modifying cells that are currently being used for a variety of diseases. In this context, the transvenous administration of MSCs must be performed correctly under controlled standards. To support clinical practitioners, the Japanese Society for Regenerative Medicine (JSRM) formed Mesenchymal Stromal Cells Infusion Working Group and developed a proposal on the management standards that should be followed by medical practitioners in the implementation of regenerative medicine regarding the transvenous administration of MSCs.This review provides a comprehensive framework for the appropriate explanation of intravenous MSC administration to patients, including detailed discussions on the associated risks, protocols for addressing potential complications during administration, and strategies for ensuring patient safety. Particular emphasis is placed on the precautions and preparations necessary to mitigate the risk of fat embolism during MSC administration. The review outlines methods for patient monitoring to prevent such adverse events, protocols for responding effectively if a fat embolism occurs, and best practices for the handling of mesenchymal stem cells to minimize the likelihood of complications. Additionally, it includes recommendations for post-administration patient observation to enhance safety and efficacy. This review further incorporates a detailed checklist aimed at facilitating safe and effective MSC administration. It emphasizes the need for implementers to exercise the highest standards of care throughout the process. By addressing key practical and safety concerns, this review aims to serve as a valuable resource for ensuring the secure and reliable application of MSC therapies in clinical practice.We hope that this paper will lead to the safe transvenous administration of mesenchymal stromal cells and that these recommendations will serve as a platform for the implementation of regenerative medicine in the future.
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spelling doaj-art-dcbc3e2f761a4ee6ac83870a14da49c72025-08-20T01:51:16ZengElsevierRegenerative Therapy2352-32042025-06-012917117610.1016/j.reth.2025.01.024Recommendations for the safe implementation of intravenous administration of mesenchymal stromal cellsShuji Terai0Sachiko Ezoe1Kyosuke Mano2Yumi Matsuzaki3Yoji Sato4Kenichi Yamahara5Hideyuki Okano6Division of Gastroenterology & Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, 1-757 Asahimachidori, Chuo-ku, Niigata 951-8510, Japan; Corresponding author.Osaka University, JapanThe Japanese Society for Regenerative Medicine (JSRM), JapanShimane University, JapanDivision of Drugs, National Institute of Health Sciences, JapanHyogo Medical University, JapanKeio University, JapanMesenchymal stromal cells (MSCs) are immunosuppressive, inflammation-reducing, and fibrosis-modifying cells that are currently being used for a variety of diseases. In this context, the transvenous administration of MSCs must be performed correctly under controlled standards. To support clinical practitioners, the Japanese Society for Regenerative Medicine (JSRM) formed Mesenchymal Stromal Cells Infusion Working Group and developed a proposal on the management standards that should be followed by medical practitioners in the implementation of regenerative medicine regarding the transvenous administration of MSCs.This review provides a comprehensive framework for the appropriate explanation of intravenous MSC administration to patients, including detailed discussions on the associated risks, protocols for addressing potential complications during administration, and strategies for ensuring patient safety. Particular emphasis is placed on the precautions and preparations necessary to mitigate the risk of fat embolism during MSC administration. The review outlines methods for patient monitoring to prevent such adverse events, protocols for responding effectively if a fat embolism occurs, and best practices for the handling of mesenchymal stem cells to minimize the likelihood of complications. Additionally, it includes recommendations for post-administration patient observation to enhance safety and efficacy. This review further incorporates a detailed checklist aimed at facilitating safe and effective MSC administration. It emphasizes the need for implementers to exercise the highest standards of care throughout the process. By addressing key practical and safety concerns, this review aims to serve as a valuable resource for ensuring the secure and reliable application of MSC therapies in clinical practice.We hope that this paper will lead to the safe transvenous administration of mesenchymal stromal cells and that these recommendations will serve as a platform for the implementation of regenerative medicine in the future.http://www.sciencedirect.com/science/article/pii/S2352320425000240Mesenchymal stromal cellsTransvenous administrationSafetyClinical useStem cell therapy
spellingShingle Shuji Terai
Sachiko Ezoe
Kyosuke Mano
Yumi Matsuzaki
Yoji Sato
Kenichi Yamahara
Hideyuki Okano
Recommendations for the safe implementation of intravenous administration of mesenchymal stromal cells
Regenerative Therapy
Mesenchymal stromal cells
Transvenous administration
Safety
Clinical use
Stem cell therapy
title Recommendations for the safe implementation of intravenous administration of mesenchymal stromal cells
title_full Recommendations for the safe implementation of intravenous administration of mesenchymal stromal cells
title_fullStr Recommendations for the safe implementation of intravenous administration of mesenchymal stromal cells
title_full_unstemmed Recommendations for the safe implementation of intravenous administration of mesenchymal stromal cells
title_short Recommendations for the safe implementation of intravenous administration of mesenchymal stromal cells
title_sort recommendations for the safe implementation of intravenous administration of mesenchymal stromal cells
topic Mesenchymal stromal cells
Transvenous administration
Safety
Clinical use
Stem cell therapy
url http://www.sciencedirect.com/science/article/pii/S2352320425000240
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