Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

WMDA StandardTitle and link to documentExplanationStatus

8.05

Recommendation for recombinant human G-CSF (G-CSF) that stem cell registries can use - the use of biosimilar G-CSF

WMDA recommendation on the use of biosimilar filgrastimsCurrent (2018)
8.05

Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation


Bone Marrow Transplantation (2018)
WMDA recommends that Stem Cell Donor Registries can use filgrastim biosimilars for the mobilisation of peripheral blood progenitor cells in healthy donors, provided that they are approved by national and/or regional agencies.Current (2018)
3.03

Remuneration of hematopoietic stem cell donors: principles and perspective of the World Marrow Donor Association.

Blood (2010) 117: 21-25

This paper describes the reasons that the WMDA continues to believe that HSC donors should not be paid due to ethical concerns raised by remuneration, potential to damage the public will to act altruistically, the potential for coercion and exploitation of donors, increased risk to patients, harm to local transplantation programs and international stem cell exchange, and the possibility of benefiting some patients while disadvantaging others.Current (2017)
1.08

Audits of collection and apheresis centers: guidelines by the World Marrow Donor Association Working Group Quality and Regulation

Bone Marrow Transplantation (2018)

This paper describes the general requirements and recommendations for collaboration with the collection and apheresis centers and define critical procedures for the collection of the stem cell product, such as information session, medical assessment, product collection, quality controls, product handover for transportation, and donor follow-up. The specific guidelines are accompanied by detailed checklists and forms that can be found in Supplementary Information and may be used during an initial or follow-up on-site or paper-based audit. For more information you can visit: https://share.wmda.info/x/OAKQEQCurrent (2018)
8.07.1

Introduction and Importance of a Globally Unique Identity and Labelling Format (ISBT-128)

Attachment A

Attachment B

This position paper encourages the benefit and criticality of a globally unique numbering system, WMDA recognizes the ISBT 128 labelling standard as one that supports full traceability of cellular therapy products from the donor to the patient bedside and the flexibility to protect confidential information as defined by current and future international regulations. 

Under revision. Paper is from 2010.

Susie Joron

8.08

World Marrow Donor Association (WMDA) Guidelines for Couriers and the Transportation of Haemopoietic Progenitor Cells (HPC-BM, Apheresis and Therapeutic Cells- T Cells) 

The paper describes recommendations for couriers and the transportation of haematopoietic progenitor cells.Current (2017)
8.08Validation of Product Transportation ContainersDevelop WMDA guidelines for validation of transport containers used for the distribution of HSC productsTo be developedCurrent (2018)
8.07Circular of Information for the Use of Cellular Therapy Products

The Circular of Information (Circular) for the Use of Cellular Therapy Products is intended to be an extension of the cellular therapy product label. It has been jointly prepared by the AABB Circular of Information Cellular Therapies Task Force, which includesa collaborative group of multiple nongovernmental organizations that represent the cellular therapy field. The US Food and Drug Administration and the Health Resources and Service Administration also participated in the development and review process. 

The Task Force intentionally limited its scope to only include minimally manipulated cellular therapy products such as peripheral blood progenitor cells, bone marrow, cord blood and leukocytes. The group recognizes there are multiple cellular therapy products that could not be adequately covered in the Circular. To accommodate this, the Circular includes multiple blank pages at the end of the document to allow for the addition of product or facility specific information.

Current (2018)

...