Hematopoietic Graft Handling During Transportation

Abstract

The cell source for hematopoietic cell transplantation (HCT) can be autologous, related allogeneic, or unrelated allogeneic. Autologous cell therapy (CT) and related allogeneic CD34⁺ cell products are often collected and processed in the same facility as the transplant center. This is not the case, however, for unrelated donor cord blood, peripheral blood, or bone marrow transplantation that are facilitated by registries—such as the National Marrow Donor Program (NMDP) and the World Marrow Donor Association (WMDA)—that are involved in the public exchange of these allogeneic CT products worldwide. Non-cryopreserved and cryopreserved allogeneic CT products are, therefore, frequently transferred on public roads as well as on aircrafts to geographically distant facilities. Since the infusion is usually scheduled within 48–72 h after collection (for non-cryopreserved CT products) or after receipt at the transplant center (for cryopreserved CT products), this process mandates complex coordination by highly trained personnel. The process of transferring CT products is tightly regulated by the Food and Drug Administration (FDA), Department of Transportation (DOT), International Air Transport Association (IATA), International Civil Aviation Organization (ICAO), AABB (formerly known as the American Association of Blood Banks), and Foundation for the Accreditation of Cellular Therapy (FACT). The regulations that must be followed depend on the hazardous material classification of the biological and cryogenic substances in the transfer container. The requirements for continuous temperature monitoring and the procedures for packaging, labeling, and documentation are all designed to maintain the integrity of the CT product while protecting the health and safety of personnel involved in the transfer process. It is essential to clearly document the chain of custody as the CT product is transferred from the cosigner (transfer facility) to the consignee (receiving facility) via the courier. Upon receipt, trained personnel at the receiving facility should promptly follow the instructions for opening the container and inspecting the CT product as well as make a decision to accept, reject, or quarantine the CT product.