June 2010

The CAP has 30 official liaisons to various organizations who attend scientific meetings or designate others to do so. They report to the Standards Committee, which reports to the Council on Scientific Affairs. We begin this month to publish on a periodic basis bits of what the CAP’s outbound liaisons hear and see in their liaison roles.

Elizabeth M. Van Cott, MD,
Zbigniew M. Szczepiorkowski, MD, PhD

The International Society for Cellular Therapy regularly holds a meeting with the Food and Drug Administration Center for Biologics Evaluation and Research to serve as a conduit of communication between the FDA and medical groups in the cell therapy field. These groups include parties involved with stem cell transplants, cord blood, immunotherapy, regenerative medicine, and transplants of other tissues such as bone marrow, cornea, and bone. These ISCT meetings began in 2004, spurred by the success of longtime, similar meetings of the FDA and medical groups involved in blood component management. The ISCT meetings usually take place twice per year in Bethesda, Md.

The CAP is one of more than 20 invited stakeholders. It has a Laboratory Accreditation Program inspection checklist for cell therapy, as well as stem cell and cord blood Surveys. In addition, many directors of cell therapy laboratories are pathologists. For these reasons, it is important for the CAP to have a voice at this meeting by sending a liaison.

The topic of the fall 2009 meeting was information technology in cell therapy. Speakers from various member organizations discussed tracking adverse reactions and errors to detect safety problems, as well as the use of databases for inventory control. They presented the challenges encountered when establishing a laboratory information system for a cellular therapy lab, including the need to create many of the protocols themselves. In addition, an informal survey showed that many tissue banks use only paper-based systems.

Why are cell therapy laboratories lagging when it comes to modern information technology? The likely reason is their fairly small market size, which deters vendors from developing products in this area. Furthermore, the issue of “one patient, one lot” means that solutions available for pharmacies are less likely to work similarly for cell therapy products. “One lot, one patient” means that in cellular therapy you have one specific product per one specific patient. This is generally not true for blood banking where the same unit of blood could be used for many patients with appropriate ABO type. By comparison, in pharmacy, there may be thousands of bottles of a particular lot of a medication, in which case one lot equals very many patients. This issue has been identified as a leading barrier to a larger presence of information technology in cell therapy laboratories.