Every year, nearly 30,000 volunteer donors are asked to donate blood stem cells to a patient they do not know. To ensure the continued viability of the global system using volunteer donors, donor health and safety are of critical importance.

WMDA collects Serious (Product) Events and Adverse Reactions –S(P)EARs– via an online reporting tool (SPEAR), to gain insight in the occurrence of serious events and adverse effects in relation to donation by volunteer donors and collection/processing of these cells. Reporting of incidents is mandatory for those in full compliance with WMDA certification and available to all those who have incidents to report.

WMDA firmly supports voluntary and unpaid donation of Substances of Human Origin (SoHO) while advocating against any financial gain from the human body or its parts. The manufacturing of cell and gene therapies, including SoHO-derived ATMPs, and medical devices, involves the transformation of SoHO used as starting material.

To ensure WMDA’s donor protection and safety standards are aligned with developments in this emerging landscapethe and safeguarding the safety and equity of access for donors and patients, WMDA has created the Cell and Gene Therapy (CGT) Committee. This group of experts focuses on donor safety, ethical dilemmas, alignment with emerging standards, and promoting dialogue with stakeholders.

Normal individuals face a lifetime risk of developing cancer, including leukemia, lymphoma or other blood diseases throughout their lifetime. G-CSF stimulates normal blood cell growth. In some patients with cancer or abnormal blood cells, it has also been shown to stimulate leukemic blood cells. However, studies following large numbers of unrelated donors have shown that the risk of developing cancer within several years after the use of G-CSF is not increased compared to donors not receiving G-CSF.

These large studies on donors were performed using the types of G-CSF called Neupogen (filgrastim, Amgen) or Granocyte (lenograstim, Chugai). Other types of G-CSF called biosimilars (or follow-on biologics) have minor differences.

Based on a recent survey of forty-two organisations performed by the Donor Care Pillar of WMDA, and a review of the literature, the WMDA recommendation on the use of biosimilar filgrastims follows:

• Stem cell donor registries or their affiliated organisations may use filgrastim biosimilars, provided that they are approved by national and/or regional agencies for CD34-positive cell mobilisation in healthy donors or equivalent wording. Donors on approved research protocols are exempt from this restriction.
• Registries adopting a new filgrastim biosimilar should establish a policy to continue following donors to identify any adverse effects possibly caused by the biosimilar.
• Registries must report adverse events and reactions (SPEAR report) as per usual practice, in addition registries MUST record the specific brand of mobilising agent in the SPEAR report.

Currently, WMDA cannot recommend the routine use of GM-CSF, plerixafor or similar mobilising agents, but recognises that there may be situations where their use is appropriate per individual situations.

Donor anonymity is assured during the search and donation process, but about 35% of organisations that provide haematopoietic stem cells do allow direct donor-recipient meetings post-donation.

If there is interaction with the donor for research purposes, or if the donor’s identifiable data will be included in the research, a donor is considered a research subject. WMDA recommends establishing procedures to ensure such requests are handled efficiently.

Once back home, donors have the satisfaction of knowing that their choice made the difference in someone else’s life.

Most countries have a robust biovigilance and follow-up system that guarantees the well-being of the donor. A donor registry will contact the donor on a regular basis to monitor their health. WMDA encourages internal data collection on donor complications both during and following donation. Donor follow-up is recommended at 30 days after collection, one year, five years and then 10 years after donation to ensure the maximum donor safety.

Subsequent donations are requested in 5–10% of donations. This means that donors can be requested to donate another product for the same or a different recipient. Recent studies have shown that donation-related symptoms for second donations are similar to those for the first donation.

The WMDA Medical Committee serves as a international resource for donor and collection centres, registries, and transplant facilities, providing vital guidance on medical and ethical aspects of HPC, marrow, or blood cell donation.

 

Among the committee’s accomplished projects are recommendations on subsequent donation, donor mental health assessment guidance, and comprehensive recommendations on donor genetic findings, which prioritises donor well-being and advocates for transparent policies on incidental findings [link to article: https://www.sciencedirect.com/science/article/pii/S2666636723017086].