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WMDA Donor Medical Suitability Recommendations



Disclaimer

These guidelines exist as an aid to organisations in assessing the medical suitability of their (maternal) donors. Please be reminded that these guidelines are not intended to supersede local laws or requirements of national legislative bodies.Ā 


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 WMDA donor medical suitability committee. 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.



WMDA Recommendations for assessing donor medical suitability

Table 1Ā - Recommended minimum medical and lifestyle information obtained at recruitment

Table 2Ā - Recommended minimum medical and lifestyle information obtained at confirmatory/verification typing stage

Table 3Ā - Recommended minimum medical assessment at work-up

Table 4Ā - Recommended minimum standard of donor infectious disease marker testing

Table 5Ā - Recommended schedule of repeating donor assessments in the event of a delay to collection




Alphabetical index of individual medical guidelines

A

Acupuncture, seeĀ Tattoo, body piercing and acupuncture

Alcohol intake

Alcoholism, seeĀ Alcohol intake

Allergy

Alopecia areata, seeĀ Single organ autoimmune disease

Anaemia

Anaphylaxis, seeĀ Allergy

Angina, seeĀ Coronary artery disease

Ankylosing spondylitis, seeĀ Back complaints

Antiphospholipid syndrome, seeĀ Thrombosis and Thrombophilia

Antithrombin III (ATIII) deficiency, seeĀ Thrombosis and Thrombophilia

Aortic regurgitation, seeĀ Valvular heart disease

Aortic stenosis, seeĀ Valvular heart disease

Arrhythmia

Arterial thrombosis, seeĀ Thrombosis and Thrombophilia

Asthma

Atrial fibrillation/flutter, seeĀ Arrhythmia

Atopy, seeĀ Allergy

B

Babesiosis

Back complaints

Back, fracture, seeĀ Back complaints

Back, surgery, seeĀ Back complaints

Basal cell carcinoma, seeĀ Malignancy

Benign atrial/ventricular ectopics, seeĀ Arrhythmia

Benign tumors

Bicuspid aortic valve, seeĀ Valvular heart disease

Bipolar affective disorder

Bleeding disorders

Blood pressure, seeĀ Hypertension

BMI, seeĀ Weight

Body piercing, seeĀ Tattoo, body piercing and acupuncture

Bronchial asthma, seeĀ Asthma

Brugada syndrome, seeĀ Arrhythmia

Budd-Chiari syndrome, seeĀ Thrombosis and Thrombophilia

C

Cancer, seeĀ Malignancy

Cerebral venous sinus thrombosis, seeĀ Thrombosis and Thrombophilia

Cerebrovascular disease

Cevical carcinoma in-situ, seeĀ Malignancy

Chagas disease

Choreoretinitis, seeĀ Inflammatory eye disease

Chronic fatigue syndrome, seeĀ Myalgic encephalomyelitis

Chronic obstructive pulmonary disease

CMV, seeĀ Cytomegalovirus

Coeliac/celiac disease, seeĀ Single organ autoimmune disease

Complete heart block, seeĀ Arrhythmia

COAD/COPD, seeĀ Chronic obstructive pulmonary disease

Conjunctivitis, seeĀ Inflammatory eye disease

Cornea transplant, seeĀ Prion-associated disease

Coronary artery disease

Coumarin therapy, seeĀ Bleeding disorders

Creutzfeld-Jacob disease (CJD, vCJD), seeĀ Prion-associated disease

Crohn's disease, seeĀ Severe or systemic autoimmune disease

Cytomegalovirus

D

Deep vein thrombosis (DVT), seeĀ Thrombosis and Thrombophilia

Dengue Fever

Depression

Diabetes mellitus

E

Ebola, seeĀ Viral haemorrhagic fever

Ebstein anomaly, seeĀ Valvular heart disease

EBV, seeĀ Epstein Barr Virus

Eczema

Endometriosis

Emphysema, seeĀ Chronic obstructive pulmonary disease

Endoscopy, seeĀ Surgery

Epilepsy

Episcleritis, seeĀ Inflammatory eye disease

Epstein Barr Virus

F

Factor II (prothrombin) mutation, seeĀ Thrombosis and Thrombophilia

Factor V Leiden, seeĀ Thrombosis and Thrombophilia

Fibromyalgia

First degree heart block, seeĀ Arrhythmia

G

Glaucoma

Glomerulonephritis, seeĀ Renal disease

Goodpasture syndrome, seeĀ Severe or systemic autoimmune disease

Graves disease, seeĀ Single organ autoimmune disease

Guillain-Barre syndrome, seeĀ Severe or systemic autoimmune disease

Gout

H

Haemoglobin disorder

Haemophilia (any type), seeĀ Bleeding disorders

Hashimoto thyroiditis, seeĀ Single organ autoimmune disease

Hayfever, seeĀ Allergy

HbC, HbD, HbE, HbO, seeĀ Haemoglobin disorder

Heart attack, seeĀ Coronary artery disease

Heart block, seeĀ Arrhythmia

Heart murmur, seeĀ Valvular heart disease

Hemochromatosis

Heparin therapy, seeĀ Bleeding disorders

Hepatitis B

Hepatitis C

Hereditary haemorrhagic telangiectasia, seeĀ Bleeding disorders

Herniated intervertebral disc, seeĀ Back complaints

Herpes simplex virus

High affinity haemoglobin, seeĀ Haemoglobin disorder

High blood pressure, seeĀ Hypertension

High risk sexual behaviour

HIV

Hormone replacement therapy, seeĀ Prion-associated disease

HSV, seeĀ Herpes Simplex Virus

HTLV infection

Hypertension

Hyperthyroidism, seeĀ Single organ autoimmune disease

Hypothyroidism, seeĀ Single organ autoimmune disease

I

IgA nephropathy, seeĀ Renal disease

Immune thrombocytopenia, seeĀ Bleeding disorders

Implantable cardiac defibrillator (ICD), seeĀ Arrhythmia

Inflammatory bowel disease, seeĀ Severe or systemic autoimmune disease

Inflammatory eye disease

Innocent murmur, seeĀ Valvular heart disease

Injection of non-prescription drugs

Innoculation injury

Iridocyclitis, seeĀ Inflammatory eye disease

Iritis, seeĀ Inflammatory eye disease

Ischaemic heart disease (IHD), seeĀ Coronary artery disease

J

Jugular vein thrombosis, seeĀ Thrombosis and Thrombophilia

K

Kidney stones, seeĀ Renal disease

L

Latex allergy, seeĀ Allergy

Left bundle branch block, seeĀ Arrhythmia

Long-QT syndrome, seeĀ Arrhythmia

Lown-Ganong-Levine syndrome, seeĀ Arrhythmia

M

Malaria

Malignancy

Manic depressive disorder, seeĀ Bipolar affective disorder

Marburg, seeĀ Viral haemorrhagic fever

Mitral regurgitation, seeĀ Valvular heart disease

Mitral stenosis, seeĀ Valvular heart disease

Mitral valve prolapse, seeĀ Valvular heart disease

Monoclonal gammopathy of undetermined significance

Multiple sclerosis, seeĀ Severe or systemic autoimmune disease

Murmur, seeĀ Valvular heart disease

Myalgic encephalomyelitisĀ (ME)

Myocardial infarction (MI), seeĀ Coronary artery disease

N

Needlestick injury, seeĀ Innoculation injury

Nephrectomy, seeĀ Renal disease

Nephritis, seeĀ Renal disease

Nephrolithiasis, seeĀ Renal disease

Nephrotic syndrome, seeĀ Renal disease

O

Osler-Weber-Rendu syndrome, seeĀ Bleeding disorders

Oral anticoagulant therapy, seeĀ Bleeding disorders

Osteoporosis

Overweight, seeĀ Weight

P

Pacemaker, seeĀ Arrhythmia

Paget-Schroetter syndrome, seeĀ Thrombosis and Thrombophilia

Pernicious anaemia, seeĀ Single organ autoimmune disease

Paroxysmal nocturnal haemoglobinuria (PNH), seeĀ Thrombosis and Thrombophilia

Pneumothorax

Portal vein thrombosis, seeĀ Thrombosis and Thrombophilia

Pregnancy

Prion-associated disease

Prolapsed intervertebral disc, seeĀ Back complaints

Protein C deficiency, seeĀ Thrombosis and Thrombophilia

Protein S deficiency, seeĀ Thrombosis and Thrombophilia

Prostitution, seeĀ High risk sexual behaviour

Psoriasis, seeĀ Single organ autoimmune disease

Pulmonary embolus/embolism (PE), seeĀ Thrombosis and Thrombophilia

Pulmonary regurgitation, seeĀ Valvular heart disease

Pulmonary stenosis, seeĀ Valvular heart disease

Q

R

Renal colic, seeĀ Renal disease

Renal disease

Renal vein thrombosis, seeĀ Thrombosis and Thrombophilia

Retinitis pigmentosa

Rheumatoid arthritis, seeĀ Severe or systemic autoimmune disease

Right bundle branch block, seeĀ Arrhythmia

S

Sarcoidosis, seeĀ Severe or systemic autoimmune disease

Sciatica, seeĀ Back complaints

Scleritis, seeĀ Inflammatory eye disease

Scleroderma, seeĀ Severe or systemic autoimmune disease

Second degree heart block, seeĀ Arrhythmia

Seizure, seeĀ Epilepsy

Sex worker, seeĀ High risk sexual behaviour

Severe or systemic autoimmune disease

Sickle cell disease, seeĀ Haemoglobin disorder

Sickle cell trait, seeĀ Haemoglobin disorder

Single organ autoimmune disease

Sinus bradycardia, seeĀ Arrhythmia

Sinus tachycardia, seeĀ Arrhythmia

Spinal stenosis, seeĀ Back complaints

Spondylitis, seeĀ Back complaints

Spondylolisthesis, seeĀ Back complaints

Stroke, seeĀ Cerebrovascular disease

Supraventricular tachycardia, seeĀ Arrhythmia

Surgery

SVT, seeĀ Arrhythmia

Syphilis

Systemic lupus erythematosus (SLE), seeĀ Severe or systemic autoimmune disease

T

Tattoo, body piercing and acupuncture

Thalassaemia, seeĀ Haemoglobin disorder

Thrombosis and Thrombophilia

Thrombotic thrombocytopenic purpura (TTP), seeĀ Severe or systemic autoimmune diseaseĀ orĀ Bleeding disorders

Thyroid disease, seeĀ Single organ autoimmune disease

Toxoplasmosis

Transfusion

Transient ischaemic attack (TIA), seeĀ Cerebrovascular disease

Tuberculosis

U

Ulcerative colitis, seeĀ Severe or systemic autoimmune disease

Underweight, seeĀ Weight

V

Valvular heart disease

Ventricular tachycardia/fibrillation, seeĀ Arrhythmia

Viral haemorrhagic fever

Vitiligo, seeĀ Single organ autoimmune disease

Von Willebrand disease (vWD), seeĀ Bleeding disorders

Vitamin K deficiency, seeĀ Bleeding disorders

W

Warfarin therapy, seeĀ Bleeding disorders

Wegener granulomatosis, seeĀ Severe or systemic autoimmune disease

Weight

Wenckebach (Mobitz I) heart block, seeĀ Arrhythmia

West Nile Virus

Whiplash, seeĀ Back complaints

X

Y

Z