LAUSR

A substantial volume of the umbilical cord blood used in clinical therapies around the world is transported between countries. The unit of cord blood that is the best biological match for a particular patient frequently has been collected, processed and stored in another country. Unfortunately, the laws and regulations for cord blood banking vary greatly from country to country, thus complicating the movement of critically needed cells. For this reason, the Cord Blood Association has developed “model criteria” for banking rules and regulations. The purpose of the Model Criteria is to (1) harmonize regulations among countries where regulations currently exist, (2) guide the development of regulations in countries where few exist, and (3) assist cord blood banks that are not accredited. These criteria should not be viewed as optimal standards, such as those developed and promulgated by accrediting agencies such as AABB and the Foundation for the Accreditation of Cellular Therapy (FACT). Rather, the Model Criteria are minimum requirements for national-level laws and regulations that govern cord blood banks and cord blood banking. The Model Criteria were developed by the CBA Government & Global Affairs Committee, with representatives from 15 countries. No gap analysis was performed to compare the Model Criteria to existing laws and regulations of any country. Rather, the committee’s process has been driven by evidence and consensus to establish criteria that can be updated in the future as laboratory and clinical advances occur in cord blood banking and in cord blood-based therapies. The draft Model Criteria were circulated to association members for comment, and then published for public comment. The committee considered all submitted comments and finalized the draft that was then adopted as association policy by the CBA Board of Directors. Except where specified in the text, these Model Criteria are applicable to both unrelated and related cord blood banking. Cord Blood