Summary statement from The Foundation for the Accreditation of Cellular Therapy to:

Cellular, Tissue and Gene Therapies Advisory Committee

March 30, 2007

 

Approximately 20% of cord blood units transplanted to patients in the United States are imported, and both that number and the percentage of imported units overall is increasing. Governmental regulation of cord blood banking activities varies from country to country. However, comprehensive professional standards and a rigorous voluntary accreditation program have been developed and implemented internationally since 2000 by FACT, the Foundation for the Accreditation of Cellular Therapy, and NetCord, The International NetCord Foundation; and the number of participants continues to grow. The goals of these Cord Blood Banking Standards and the associated accreditation process are:

to promote quality practices in maternal and donor selection, screening, and testing; and in cord blood collection, processing, testing, banking, selection, release, and transport.

to consistently assure the provision of quality cord blood units for transplantation to patients worldwide who could potentially benefit from such therapy.

protect the research and development in this rapidly evolving field.

 

Professional accreditation should be considered as an important measure of quality of the cord blood bank and of the units manufactured therein. Import and export of cord blood units is critical to the care of patients whose most appropriate cellular therapy product was collected in another country. As established by FACT-NetCord, the accredited cord blood bank must successfully address the same issues detailed by the FDA in its guidance document related to proposed licensure. The Agency should be able to allow access to cord blood units from accredited banks with the confidence that safety, purity, potency, and identity are all controlled processes within the accredited cord blood bank.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Phyllis I. Warkentin, MD

March 30, 2007