New international standards for cell therapy and cord blood cell transplantation

摘要

Cord Blood Cell (CBC) transplantation is successfully applied for the treatment of various diseases due to the great potential of its advantageous characteristics regarding plasticity and compatibility. Nevertheless, in order to achieve greater levels of applicability, CBC ex vivo expansion cultures are required in certain occasions. As cellular expanded products for transplantation, pre-clinical safety is a great matter of concern before its use.  Transplantation and Cellular Therapy Programs should fulfill quality requirements, both national and international, and a certain number of organizations have been dedicated to establish accreditation processes based on standards. Since the draft of the 6th Edition of the International Standards, jointly proposed by The Foundation for the Accreditation of Cellular Therapy and the Joint Accreditation Committee of the International Society for Cellular Therapy and the European Society for the Blood and Bone Transplant (FACT-JACIE), as well as the draft for review and comment  of The Common Standards for Cellular Therapies were published, both quality management documents are commented, due to the fact that they establish minimal working guidelines for Programs, Facilities, and Persons working on Cellular Therapies and Transplantation or giving support services for such procedures. Some evidences of the usefulness of this accreditation processes and their importance for achieving better working results in transplantation and cellular therapy are shown.