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

Abstract

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.