The global independent, professionally-led biovigilance scheme
WMDA is operating the global independent, professionally-led biovigilance scheme. Since 2003 WMDA has been collecting and analysing anonymised information on adverse events and reactions in stem cell donation and transfusion from all member organisations that are involved in the provision of cells for unrelated patients. Where risks and problems are identified, WMDA produces recommendations to improve donor and patient safety. The recommendations are put into its annual report which is then circulated to all relevant professional bodies as well as circulating it to all of the reporting WMDA member organisations. As biovigilance is an ongoing exercise, WMDA can also monitor the effect of the implementation of its recommendations and ensure donor care through its accreditation programme.
The Donor Care Pillar of WMDA is operating the biovigilance programme and ensures that recommendations are in place to protect the donor for all type of donatioins till years after donation.
Donor Care - biovigilance reporting
The WMDA collects Serious (Product) Events and Adverse Reactions –S(P)EARs– via an online reporting tool: SPEAR. The aim of the SPEAR system is to gain insight in the occurrence of serious events and adverse effects in relation to blood stem cell donation by volunteer donors and blood stem cell collection/processing from volunteer donors. Reporting for related donors is highly encouraged as well, WMDA welcomes the reports from related donors coming in.
Donor Care - novel therapies
The cellular therapy committee is focusing on:
- Identifying the role WMDA can play in safeguarding the safety and equity of access for donors and patients
- Addressing current issues, such as ethical dilemmas, that are raised by changing the role of stem cell donors
- Ensuring WMDA’s donor protection and safety standards are aligned with developments in this emerging landscape
- Establishing a collaborative space facilitate dialogues with different stakeholders
Donor Care - use of mobilising agents
Normal individuals are at risk for 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. 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.
- If a new filgrastim biosimilar is used by a registry or its affiliated organisation, the registry should have a policy to continue to follow donors to identify any adverse effect possibly caused by the biosimilar.
- Stem cell donor registries must report adverse events and reactions (SEAR and SPEAR) as per usual practice, in addition registries MUST record the specific brand of mobilising agent in the S(P)EAR report.
Currently, WMDA cannot recommend the routine use of GM-CSF, plerixafor or similar mobilizing agents, but recognises that there may be situations where their use is appropriate per individual situations.
Donor Care - suitable to donate or not?
Link to the Wiki, click here.
Donor Care - data transparency
A donor is considered as a research subject if there is interaction with the donor for research purposes, or if the donor’s identifiable data will be included in the research; WMDA recommends establishing procedures to ensure such requests are handled efficiently.
Donor Care - post donation
In most countries there is a structured and robust bio-vigilance and surveillance system that guarantees the well-being of the donor. Your donor registry will contact you on a regular basis to monitor your health. WMDA encourages internal data collection on donor complications both during and following donation. A donor follow-up is recommended 30 days after collection, and then one year, five years and 10 years after donation. Data collection of short and long-term donor adverse reactions is crucial to ensure the maximum donor safety.
In 5–10% of donations, a subsequent donation may be requested; that means that donors can be requested to donate another product for the same or different recipient. Recent studies have shown that donation-related symptoms for second donations are similar to those for the first donation.