« Mesenchymal stem cells in the regeneration of radiation-induced organ sequelae, will MSC make the difference?"»

Abstract Mesenchymal stromal cells (MSC) are a stem cell product with good safety that demonstrate significant clinical efficacy in the treatment of different pathologies, including radiation diseases (radiological burn, pelvic radiation disease). While the results of some first human application for the treatment of radiation disease suggest benefit, larger trials with clinically important endpoints are needed before definitive conclusions can be drawn. However, the access of MSC and the cost remain the two main limits for this innovative therapeutic product. Exosomes (EXO), a stem cell product associated with MSC therapy, have shown promising efficacy and safety in humans. MSC-EXO therapeutics represent a promising next-generation approach for treating radiation diseases involving a primary (major) inflammatory component. Provided that, conditions for MSC-EXO production and bio-banking will reach consensus in the next future, the transition to industrial production of MSC-EXO will be possible and is required to initiate well control clinical trial for EMA or FDA approval.