This evidence enables WMDA to:

• Identify emerging risks early
• Develop and update evidence‑based recommendations
• Promote continuous improvement in donor and patient care across countries and systems

Reporting of adverse events through WMDA’s SPEAR system is mandatory for certified members and available to all organisations (including regulatory bodies) involved in donation activities.

Donor care does not end when donation is completed.

WMDA continuously evaluates both short‑term and long‑term donor outcomes, using global data to ensure that donation practices remain safe. Long‑standing evidence, including extensive follow‑up of donors mobilised with G‑CSF, demonstrates no increased long‑term cancer risk compared with non‑donors.

WMDA also provides clear guidance on:

• Appropriate use of mobilising agents
• Reporting requirements for specific products
• Ongoing evaluation of advanced therapies

Information Links

• Allogeneic hematopoietic stem cell donation—standardized assessment of donor outcome data: A consensus statement from the Worldwide Network for Blood and Marrow Transplantation (WBMT)
• Donor Assessment Post Stem Cell Donation Form
• Annual Donor Assessment Post Stem Cell Donation

What is plerixafor?

Plerixafor is a stem cell mobilising agent that increases the number of stem cells released from the bone marrow into the bloodstream, where they can be collected by apheresis. It has been used safely for many years in autologous transplantation and is now increasingly used in selected allogeneic donor situations.

When may plerixafor be used?

According to WMDA guidance, plerixafor may be considered in healthy donors:

• When stem cell mobilisation with G‑CSF alone is insufficient
• When collection after a first apheresis does not reach the required dose
• In carefully selected cases where poor mobilisation is anticipated

The guidance confirms that plerixafor can be used safely alongside G‑CSF, reducing the need for extended donation or additional collection days, thereby lowering the burden on donors and avoiding delays for patients.

Why this matters

• Improves donor experience by avoiding repeat collections
• Enhances reliability of timely transplantation
• Ensures consistent, evidence‑based use across countries

WMDA continues to monitor outcomes and will update guidance as further evidence becomes available.

WMDA strongly advocates for:

• Voluntary and unpaid donation
• Protection of donor autonomy and informed consent
• Transparency regarding risks, procedures, and follow‑up

Donor eligibility recommendations are developed through international expert consensus and are publicly available to support consistent assessments worldwide.

Donor anonymity is safeguarded throughout the process, with post‑donation contact only permitted in accordance with national regulations.

• Donor safety in advanced and experimental therapies
• Ethical considerations for healthy volunteers
• Alignment with evolving regulatory frameworks

This ensures that donor care standards remain robust as medical innovation accelerates.

Information Link:

• Remuneration of donors for cell and gene therapies: an update on the principles and perspective of the World Marrow Donor Association
• Genetic Findings of Potential Donor Origin in Cells Used for Cell and Gene Therapy: Recommendations from the World Marrow Donor Association