Cord Blood Bank Standards
The major objective of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration is to promote quality medical practices, laboratory processes, and banking to achieve consistent production of high quality placental and umbilical cord blood units for administration. These Standards apply to cord blood units intended for unrelated allogeneic use and to related units collected and stored for allogeneic or autologous use by a donor family. All phases of cord blood collection, banking, and release for administration are included:
- Donor management, including screening, testing, and eligibility determination of infant and maternal donors
- Collection, regardless of the methodology or site of collection
- Testing and characterization of the unit
- Listing, either directly or through a search registry
- Search, selection, and reservation
- Distribution to clinical programs, whether fresh or cryopreserved
These Standards only apply to umbilical cord tissue as it relates to samples for testing. Storage of umbilical cord tissue for therapeutic intent is covered under the FACT Common Standards for Cellular Therapies. Standards for the administration of cord blood cells, either allogeneic or autologous, are covered in the Clinical Program section of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration.
These Standards were developed by consensus, based on the best available evidence-based science, placing emphasis on research findings related to clinical outcomes of cord blood recipients. Cord blood banking is an emerging and evolving field. For those areas where there are little or no definitive data on clinical outcomes relating to a particular standard, the Standards Committee weighed the available evidence from preclinical studies and accepted scientific theory.
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