WMDA Donor Medical Suitability Recommendations

Disclaimer

These guidelines exist as an aid to unrelated adult haematopoietic stem cell donor registries in assessing the medical suitability of their donors. However, donor registries are reminded that these guidelines are not intended to supersede local laws or requirements of national legislative bodies.

About the WMDA donor medical suitability guidelines

Guidance provided by the World Marrow Donor Association (WMDA) aims to provide minimum standards by which potential donors should be assessed.

The guidance below reflects the consensus opinion provided by the donor medical suitability working group of the WMDA. The purpose of this guidance is to provide globally harmonised medical assessment criteria which simultaneously protect the interest of donors whilst ensuring the safety of cellular products across international boundaries.

How donor medical suitability is assessed

Two key concepts govern the assessment of donor health, namely restrictive criteria for donor risk and more permissive criteria for recipient risk

Donor risk

Donation of hematopoietic stem cells (HSC) is an act of altruism, and may be to a recipient in a different country, with quite different moral, cultural and religious values.

Whilst it is recognised that the process of donation carries a small but unavoidable risk of harm to the donor, it is both the moral and legal responsibility of donor registries and donor centres to minimise any avoidable risk. This includes medical conditions that may increase the risk of harm to the donor before, during, and after the collection of HSC.

For this reason, medical criteria governing conditions that may increase donor risk are necessarily stringent, and certainly more so than would be the case if the individual were undergoing a procedure for therapeutic benefit.

In many cases it is difficult to establish a rigorous evidence base as justification for the criteria. In such cases, expert opinion of the underlying physiology of disease will be sought, and combined with knowledge of the known physiological changes associated with donation, as well as experience gained through several decades of HSC donor follow-up and adverse event reporting.

In general, if there is any doubt about the safety of the donor in the presence of a particular medical condition, it will be recommended that any donor with that condition be prevented from donating.

Recipient risk

By contrast, our recommendations regarding conditions that may put the recipient at risk are more lenient.

For many patients, an unrelated donor HSC transplant represents the only possibility of disease cure or long-term remission. Because of the diverse nature of HLA tissue-types, many patients will have a limited number of potentially matched donors. In such cases, donor medical conditions that may present a risk to the recipient alone should be reported to the transplant centre, who are best placed to make an informed risk-benefit judgement on whether to proceed with that particular donor.

There are obvious exceptions to this, however, in particular the carriage of transmissible agents which may have more deleterious effects in the recipient. These include infectious agents such as HIV, viral hepatitis and HTLV, prion-related diseases such as Creutzfeld-Jacob Disease, and carriage of autoreactive lymphocytes causing multi-system or severe single-organ autoimmune diseases, such as systemic lupus erythematosus, multiple sclerosis or inflammatory bowel disease.

Procedure for creating and reviewing the donor medical suitability guidelines

To create and support this resource, the WMDA has established the donor medical suitability working group committee. Members of the committee represent all major regions in the world, and are themselves overseen by numerous competent authorities within their country of practice. Committee members are actively involved in donor centre and/or registry operations with experience in matters concerning unrelated donor medical suitability.

To create these initial guidelines, individual members of the working group were allocated criteria to write, which were then disseminated for review to the entire group. Consensus criteria were then agreed following consideration of all comments made.

Submitting a request for review

The WMDA welcomes requests for review of individual medical conditions from all those with responsibility for HSC donors, related or unrelated. This may be a medical condition not covered by the current guidance, or a request for clarification or review of current guidance.

Requests for new guidance, and feedback on existing guidance, are submitted to the committee chair/designate and reviewed by committee members. Comments and justifications for the committee decision are documented, including justification for the decision. Regardless of the outcome, a formal response to the query is provided to the author of each submission in order to inform the registry/donor centre of the outcome of the discussion. Recommendations that are approved are posted to this website. Any controversies pertaining to the recommendations are added to the discussion section on the relevant page.

Please email Hung Yang hyang@abmdr.org.au with your request or comments. Please include your name and affiliation as we will be unable to review anonymous requests.

Related donors

Whilst this WMDA guidance is not specifically intended for related donors, those involved with the medical assessment of related donors should consider these recommendations.