A European reference protocol for quality assessment and clinical validation of autologous haematopoietic blood progenitor and stem cell grafts

Recently, the regulatory authorities have begun to show interest in haemato poietic stem cell products, On a professional rather than a regulatory basi s, the International Society for Hematotherapy and Graft Engineering (ISHAG E) has established the Foundation for the Accreditation of Haematopoietic C ell Therapy (FACHT), which has drawn up guidelines for standards and accred itation of such activity. In Europe, the regulatory environment with regard to haematopoietic stem cell grafts, processing and storage are currently l ess stringent. However, in 1998 the European Joint Accreditation Committee Euro-ISHAGE/EBMT (JACIE) prepared a regulatory document 'Standards for Bloo d and Marrow Progenitor Cell Collection, Processing and Transplantation' wh ich was approved by the EBMT General Assembly. The major objectives were to promote quality of medical and laboratory practice in haematopoietic proge nitor cell transplantation. The standards extend and detail the pre-existin g activity of EBMT centres including all phases of collection, processing a nd administration of these cells. This is the platform for the proposed ref erence protocol for CD34(+) cell enumeration and clinical validation of qua lity assessment to ensure that appropriate standards of work and product qu ality are established and will be maintained.