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

Bone Marrow Transplantation
S Serke, H E Johnsen

Abstract

Recently, the regulatory authorities have begun to show interest in haematopoietic stem cell products. On a professional rather than a regulatory basis, the International Society for Hematotherapy and Graft Engineering (ISHAGE) has established the Foundation for the Accreditation of Haematopoietic Cell Therapy (FACHT), which has drawn up guidelines for standards and accreditation of such activity. In Europe, the regulatory environment with regard to haematopoietic stem cell grafts, processing and storage are currently less stringent. However, in 1998 the European Joint Accreditation Committee Euro-ISHAGE/EBMT (JACIE) prepared a regulatory document 'Standards for Blood and Marrow Progenitor Cell Collection, Processing and Transplantation' which was approved by the EBMT General Assembly. The major objectives were to promote quality of medical and laboratory practice in haematopoietic progenitor cell transplantation. The standards extend and detail the pre-existing activity of EBMT centres including all phases of collection, processing and administration of these cells. This is the platform for the proposed reference protocol for CD34(+) cell enumeration and clinical validation of quality assessment to ensure that appropriate stan...Continue Reading

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Citations

Mar 23, 2010·Medicina clínica·Christelle FerràUNKNOWN en Representación del Programa de Trasplante de Progenitores Hematopoyéticos del Institut Català d'Oncologia - Hospital Univ
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Jun 13, 2017·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Carolyn A Keever-TaylorLinda M Griffith
May 16, 2003·Bone Marrow Transplantation·S Heimfeld
Aug 16, 2002·Bone Marrow Transplantation·C G GisseløH E Johnsen
Oct 1, 2021·Bone Marrow Transplantation·John A SnowdenAlois Gratwohl

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