GUIDELINE FOR PROCESSING CELLULAR THERAPY PRODUCTS ROUTINELY USED FOR HEMATOPOIETIC STEM CELL TRANSPLANTATION IN JAPAN

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  • 院内における血液細胞処理のための指針

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Abstract

In Japan, about 4,000 hematopoietic stem cell transplantations (HSCT) are currently performed for various hematologic and non-hematologic disorders in about 200 hospitals per year. However, there have been no regulations or professional standards or guidelines for the processing of cellular therapy products routinely used for HSCT. Therefore, the Japan Society of Transfusion Medicine and Cell Therapy (JSTMCT), in collaboration with the Japan Society for Hematopoietic Cell Transplantation (JSHCT), have established guideline, titled 'the Japanese Standards for Processing Cellular Therapy Products Routinely Used for Hematopoietic Stem Cell Transplantation', for all hospitals and related personnel performing HSCT. According to a nation-wide survey performed by JSTMCT, it is likely that the number of medical staff and equipment is insufficient in many hospitals. Although these guidelines are based on the world-wide standard, the FACT-JACIE 3rd edition, and are intended to be minimum standards, some modifications were made to reflect the present situation of most hospitals. The guidelines include; 1 Objective, 2 Application, 3 Product Collection, 4 Personnel, 5 Equipment and Facility, 6 Policies and Procedures, 7 Distribution, 8 Storage and Thawing, 9 Sample Storage, 10 Infusion, 11 Disposal, and 12 Provision. Appendices include outlines of each procedure related to transplantation and examples of standard operation procedures (SOPs) and record forms. The established standards are to be uploaded to the JSTMCT website so that individuals can access and download the SOPs and record forms, which can be revised for use at each hospital. An accreditation system is also planned to be established in the near future.<br>

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