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<p>This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport.</p>
<p>This document is applicable to all organizations performing biobanking of hUC-MSCs used for research and development.</p>
<p>This document does not apply to hUC-MSCs for the purpose of <em>in vivo</em> application in humans, clinical applications or therapeutic use.</p>
<p>NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.</p>
Reģistrācijas numurs (WIID)
74052
Darbības sfēra
<p>This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport.</p>
<p>This document is applicable to all organizations performing biobanking of hUC-MSCs used for research and development.</p>
<p>This document does not apply to hUC-MSCs for the purpose of <em>in vivo</em> application in humans, clinical applications or therapeutic use.</p>
<p>NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.</p>