The FACT-JACIE Hematopoietic Cell Therapy Standards state, “If the intended recipient has received high-dose therapy, the cellular therapy product shall be transported.” (CM10.3.2, C10.3.2, D10.7) Some have asked what the purpose of this standard is because a product always needs to be distributed to the recipient.
The key word in this standard is “transported.” As stated by the FACT-JACIE definitions in Part A of the Standards, “transport” is the physical transfer of a cellular therapy product within or between facilities during which it does not leave the control of trained personnel at the transporting or receiving facility. In other words, someone who is trained to transfer a product must be with it at all times. This is in contrast to shipping, during which the product does leave the control of trained personnel (such as shipment on a commercial distributing company’s truck or airplane).
If a patient has undergone high-dose marrow ablative treatment in preparation for transplant, the cellular therapy product is essential for the patient’s survival since it may not be possible to obtain additional marrow or blood from the original donor or a second donor in time to prevent complications from aplasia. For this reason, it is important that the product be entrusted to a knowledgeable individual who accompanies it from the distributing facility to the receiving facility.