If tests for sterility, tumor content, and normal hematopoietic progenitor cells are acceptable, cryopreserved marrow or PBSC will be available for infusion into the patient. Upon receipt of a written request from the transplant center, the cryopreserved stem cells will be shipped by overnight air freight to the transplant center in a liquid nitrogen vapor cryogenic container. Two 2 ml test vials of product will be sent with the marrow: one will be thawed and tested for viable cell recovery at the recipient institution (CFU-G,M testing will be optional, and the other will be returned immediately (still frozen) in the shipping container to CHLA, were it will be thawed and tested for viability and CFU-G,M.

To facilitate testing of the holding time for the cryogenic transport container, it should not be recharged with liquid nitrogen, and should be returned by overnight express shipping the same day it is received.

If the cryogenic container must be retained for > 24 hours after receipt by the transplant center before returning to CHLA, then it should be recharged prior to shipping in order to insure safe transport of the frozen test vial which is thawed and assessed for viability and CFU-G,M. This procedure will help us detect unusual accidents during transport, such as irradiation or temperature shifts, that cause loss of cell viability. In addition we utilize a digital temperature monitor which records the temperature of the cryogenic container at hourly intervals throughout transport. Cryogenic containers are monitored for ability to hold cryogenic temperatures after each return shipment over a 5 day period using the same temperature recording system. If a backup product was prepared, it is shipped at a different time using the same procedure.

Although vials do not accurately predict the recovery of cells from simultaneously frozen bags we have yet to find an ideal alternative. We continue to use vials as they always underestimate the cell recovery in the bags.