Rules & Regulations: Guidelines for stem cell storage and collection

Stem Cell Regulation Report, April 28, 2006

Guidelines for stem cell storage and collection

The New York State Council on human blood and transfusion services released the following guidelines for collection and storage of cord blood stem cells in 2003.

  • Processing of cord blood should commence within 48 hours of collection.

  • Pre-processing cord blood storage temperature should be maintained at between one degree Celsius and ambient temperature, depending on methods used.

  • Cord blood should be collected and stored in vials, bags, or other containers approved for cryopreservation of hematopoietic progenitor cells or validated by the cord blood bank to maintain viability.

  • Cells should be cryopreserved by methods detailed in written procedures using reagents approved for human use. Methods should be well described in the medical literature or approved by an institutional review board. Non-human animal colloids should not be used.

  • After processing, cells should be stored within a temperature range of minus 196 degrees Celsius to minus 80 degrees Celsius. If the storage period exceeds one year, cells should be stored at a temperature of less than minus 130 degrees Celsius.

  • Cells should be stored continuously in either a mechanical freezer or liquid nitrogen tank equipped with an audible alarm.

  • Refrigeration devices used should be reserved for hematopoietic progenitor cells, other tissues intended for transplantation, and/or blood intended for transfusion.

  • A backup system should be in place in the event of unexpected mechanical failure or liquid nitrogen loss.