Abstract
Mesenchymal stromal/stem cells (MSCs) are used to treat a wide variety of diseases. The conditions for which MSCs are administered are often rare and provide an unmet medical need. The biology of MSCs, however, is still not fully understood, and the risks associated with administration of such products are not fully defined. MSCs are in most cases classified as advanced therapy medicinal products (ATMPs) based either on the substantial manipulation of the cells during the manufacturing process or their heterologous use. MSC-based ATMPs pose certain challenges for developers and regulators, including reliable characterisation/identity of cells, microbial and viral safety, biological activity/potency, relevant animal models, biodistribution and genetic stability. This review highlights the scientific and regulatory challenges of MSC-based ATMPs.
Published Version
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