scope:

This document specifies requirements for the collection, isolation, culture, expansion, characterization, quality control, cryopreservation, storage, distribution and transport of human mesenchymal stromal cells derived from bone marrow (hBM-MSCs) for biobanking. This document is applicable to all organizations performing biobanking with hBM-MSCs used for research. This document does not apply to hBM-MSCs for the purpose of in vivo application in humans, cell therapy, clinical applications, tissue engineering or therapeutic use. NOTE - International, national or regional regulations or requirements or multiple of them can also apply to specific research topics covered in this document.