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EBMT Quality Assessment of Haematopoietic Stem Cell Grafts committee

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Quality Assessment of Autologous Haematopoietic Blood Progenitors and Stem Cell Grafting: A Prospective Registration Study

INVITATION

Dear EBMT member,

As an EBMT center we hereby invite you to participate in this prospective EBMT registration study on "Quality Assessment of Autologous Blood Progenitor and Stem Cell Grafting".

This European registration protocol was initiated June 2004 and intends to move quality assessment "from CD34 numbers" into global and clinical useful probability estimates and through that establish new recommendations for autografting.

On a professional rather than a regulatory basis the objectives are to promote quality of medical and laboratory practice to ensure that appropriate standards of work and product quality are established and maintained. The aims are to establish predictive models for Autologous Haematopoietic Blood Progenitor and Stem Cell Grafting based on analysis of demographic, disease and graft related variables.

Clinical end points will be used in probability estimation of acceptable or unacceptable post-transplant supportive care (primary), side effect/toxicity (secondary) and safety (tertiary end points).

The protocol now have > 250 patients registered to date. We wish to recruit 1,000 patients by the end of 2007.

The Protocol and MED C registration forms are available as PDF and Word files here:

Synopsis | Protocol | Med-C forms

It is our hope that all EBMT centers will discuss the protocol and participate by contact to the EBMT Subcommittee Secretariat by an e-mail to: aas.h.e.johnsen@nja.dk with information about contact person and address.

On behalf of EBMT Graft Evaluation Committee:

Fransesco Lanza MD (Committee Chairman)
Section of Hematology
BMT Unit St Anna Hospital
University Corso Giovecca N. 203
44100 Ferrara
Italy

E-mail: lanza.f@ospfe.it
francesco_lanza@tin.it

Johnsen Hans E., M.D., DMSc,
Professor in Clinical Haematology Department of Haematology Aalborg Hospital,
Aarhus University Mølleparkvej 4
DK 9000 Aalborg
Denmark

Phone +45 99 32 63 40

E mail: aas.h.e.johnsen@nja.dk