|Clinical Working Group|
The mission of the Clinical Working Group (CLWG) is to be the international resource for donor centers, donor registries, cord blood banks, transplant centers and the public on all clinical matters pertaining to the donation, donor safety, transportation and infusion of hematopoietic stem and progenitor cells for transplantation.
Recommendations of the Clinical Working Group (CLWG):
Concerns about the use of Biosimilar Granulocyte Colony Stimulating Factors for the mobilization of stem cells in normal donors.
Recombinant Granulocyte Colony Stimulating Factor (G-CSF) is routinely used for the mobilisation of haematopoietic stem cells (HSC) from the bone marrow into peripheral blood for collection by apheresis for transplantation. Since the late 1990s, HSC collection from related and unrelated healthy donors has been routine in Europe and North America. Two branded forms of G-CSF have been marketed since the early 1990s and there is extensive data concerning their use in normal donors.
Since 2002, the World Marrow Donor Association (WMDA) has maintained a centralised database collecting both short and long-term adverse events in unrelated donors receiving G-CSF. Recently, G-CSF biosimilar agents have become available. Biosimilars can be licensed based on data showing comparability to the reference product for the primary indication. Here we present the available evidence for the licensing of biosimilar G-CSF for mobilisation of HSC in Europe. As the efficacy for mobilisation is extrapolated, with little safety analysis and no long-term follow-up, the WMDA recommends that biosimilars must not be used for mobilisation in normal donors unless the donor is followed on a study addressing this question. Only when comprehensive data to confirm safety and efficacy is available should use of G-CSF biosimilars be considered routine. More information about this can be found by clicking on the following links:
Unrelated donor SCT activity is increasing, and in 5–10% of cases a subsequent donation of stem cells or donor lymphocytes may be requested. Second donations of stem cells are not associated with an increased chance of donor complications, but the yield of CD34+ cells may be lower in some donors. It is acceptable practice for any registry to request subsequent donations and it is recommended that donors should be counselled about this possibility before their first donation. Guidance is provided on the requirements for further medical assessment, the procedures used to agree requests, frequency and timing of donation and timing and duration of donor follow up. Read more...
UNRELATED HEMATOPOIETIC STEM CELL DONORS AS RESEARCH SUBJECTS.
Research involving human subjects is critical to improving outcomes for recipients of HSCT and for improving the donation process for unrelated stem cell donors. WMDA calls on Registries to actively participate in research activities aimed at improving clinical outcome. Most HSCT today takes place under some research transplant protocol, but in the majority of these protocols the donor will not be regarded as a research subject. However, there will be instances where a donor is a research subject. Therefore, WMDA recommends that individual registries establish procedures for efficient handling of such kinds of donation requests to support worldwide research activities and to ensure timely donation of high-quality hematopoietic stem cells for all patients in need of an unrelated donor. Read more..
MINIMUM CRITERIA FOR A SPECIFIC DONOR TO BE AVAILABLE FOR A PATIENT
Presentations: slides of the CLWG meeting Minneapolis 2012
Minutes: link to the minutes of the previous meetings (only for WMDA members)
Chair: Bronwen Shaw, United Kingdom
Vice-chair: Jeff Szer, Australia
Last update: 11:59 20/12 2012