Promoting Donor Care

WMDA operates a global, independent, and professionally-led biovigilance scheme, ensuring the highest standards of donor and patient safety in hematopoietic stem cell (HSC) donation and transfusion. Since 2003, WMDA has collected and analysed anonymised data on adverse events and reactions from organisations worldwide, using this intelligence to generate evidence-based recommendations. These recommendations, published in our annual report, are disseminated to professional bodies and WMDA member organisations, ensuring continuous improvement in donor and patient care.

A Comprehensive Approach to Donor Safety

Every year, nearly 30,000 volunteer donors donate blood stem cells to patients they do not know. Safeguarding donor health is central to the continued viability of this global system. WMDA collects Serious (Product) Events and Adverse Reactions (S(P)EARs) via our SPEAR online reporting tool, providing critical insight into donation-related risks.

Reporting is mandatory for certified WMDA members and available to all organisations with relevant incidents.
The system captures adverse events throughout the donation, collection, processing, and transfusion cycle, enabling early detection of risks and proactive mitigation.

Adapting to Emerging Therapies

With the rise of cell and gene therapies, WMDA established the Cell and Gene Therapy (CGT) Committee, a team of experts focusing on:

Donor safety and ethical considerations in emerging therapies
Alignment with evolving regulatory and safety standards
Promoting dialogue with international stakeholders to safeguard donor and patient welfare

This proactive approach positions WMDA at the forefront of donor care in the rapidly evolving field of advanced therapies. WMDA strongly advocates for voluntary and unpaid donation of Substances of Human Origin (SoHO), opposing any financial gain from the human body or its components.

Monitoring Donor Health Over Time

The Donor Care Pillar oversees WMDA’s biovigilance program, tracking donor safety long after donation. For example, extensive studies on G-CSF mobilisation (Neupogen®/filgrastim, Granocyte®/lenograstim) demonstrate no increased risk of cancer in healthy donors compared to non-donors.

WMDA provides clear guidance on the use of biosimilar filgrastims, requiring:

Regulatory approval for mobilisation in healthy donors
Ongoing donor follow-up to detect adverse effects
Detailed reporting of the specific mobilising agent in SPEAR

WMDA continues to evaluate emerging mobilising agents such as GM-CSF and plerixafor, providing transparent, evidence-based recommendations for clinical use to protect donors globally.

Ensuring Safe, Ethical, and Informed Donations

Donor Eligibility: Consensus driven donor suitability recommendations, publicly available on WMDA Share. To access these guidelines, click here.
Donor Anonymity: Protected throughout the search and donation process, with optional post-donation meetings in ~35% of countries.
Donor as Research Subject: Strict protocols ensure identifiable donor data used in research is handled ethically and efficiently.
Long-Term Follow-Up: Donors are contacted at 30 days, 1 year, 5 years, and 10 years post-donation to monitor health. Subsequent donations, requested in 5–10% of cases, are closely monitored. Studies show that donation-related symptoms for second donations are similar to first donations, reaffirming the safety of repeated donations.

Global Standards, Centralised Expertise

WMDA’s Medical Committee provides guidance to:

Registries, collection centers, and transplant facilities
Donor safety, mental health assessments, and subsequent donation policies
Management of donor genetic findings, prioritising well-being and transparency

Recent publications outline comprehensive recommendations for donor genetic findings, reinforcing WMDA’s leadership in donor care. You will find an overview of all publications on WMDA Share, click here.

Join Us

WMDA’s donor care pillar is unique in its scope, rigor, and global reach:

Global Coverage: Data from thousands of donors across dozens of countries
Proactive Safety Measures: SPEAR reporting, donor follow-up, and safety audits
Regulatory Alignment: CGT Committee ensures emerging therapies meet ethical and safety standards
Evidence-Based Guidance: Annual reports and recommendations shared with professional and regulatory bodies

Through continuous monitoring, transparent reporting, and expert guidance, WMDA sets the international standard for donor protection, patient safety, and ethical stem cell practices. Become part of it, and join us today. Click here.

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