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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.

List of contributors to the guidelines

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 1 - Recommended minimum medical and lifestyle information obtained at recruitment

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

Table 3 - Recommended minimum medical assessment at work-up

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

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


Alphabetical index of individual medical guidelines

A

Acupuncture, see Tattoo, body piercing and acupuncture

Alcohol intake

Alcoholism, see Alcohol intake

Allergy

Alopecia areata, see Single organ autoimmune disease

Anaemia

Anaphylaxis, see Allergy

Angina, see Coronary artery disease

Ankylosing spondylitis, see Back complaints

Antiphospholipid syndrome, see Thrombosis and Thrombophilia

Antithrombin III (ATIII) deficiency, see Thrombosis and Thrombophilia

Aortic regurgitation, see Valvular heart disease

Aortic stenosis, see Valvular heart disease

Arrhythmia

Arterial thrombosis, see Thrombosis and Thrombophilia

Asthma

Atrial fibrillation/flutter, see Arrhythmia

Atopy, see Allergy

B

Babesiosis

Back complaints

Back, fracture, see Back complaints

Back, surgery, see Back complaints

Basal cell carcinoma, see Malignancy

Benign atrial/ventricular ectopics, see Arrhythmia

Bicuspid aortic valve, see Valvular heart disease

Bipolar affective disorder

Bleeding disorders

Blood pressure, see Hypertension

BMI, see Weight

Body piercing, see Tattoo, body piercing and acupuncture

Bronchial asthma, see Asthma

Brugada syndrome, see Arrhythmia

Budd-Chiari syndrome, see Thrombosis and Thrombophilia

C

Cancer, see Malignancy

Cerebral venous sinus thrombosis, see Thrombosis and Thrombophilia

Cerebrovascular disease

Cevical carcinoma in-situ, see Malignancy

Chagas disease

Choreoretinitis, see Inflammatory eye disease

Chronic fatigue syndrome, see Myalgic encephalomyelitis

Chronic obstructive pulmonary disease

CMV, see Cytomegalovirus

Coeliac/celiac disease, see Single organ autoimmune disease

Complete heart block, see Arrhythmia

COAD/COPD, see Chronic obstructive pulmonary disease

Conjunctivitis, see Inflammatory eye disease

Cornea transplant, see Prion-associated disease

Coronary artery disease

Coumarin therapy, see Bleeding disorders

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

Crohn's disease, see Severe or systemic autoimmune disease

Cytomegalovirus

D

Deep vein thrombosis (DVT), see Thrombosis and Thrombophilia

Dengue Fever

Depression

Diabetes mellitus

E

Ebola, see Viral haemorrhagic fever

Ebstein anomaly, see Valvular heart disease

EBV, see Epstein Barr Virus

Eczema

Emphysema, see Chronic obstructive pulmonary disease

Endoscopy, see Surgery

Epilepsy

Episcleritis, see Inflammatory eye disease

Epstein Barr Virus

F

Factor II (prothrombin) mutation, see Thrombosis and Thrombophilia

Factor V Leiden, see Thrombosis and Thrombophilia

Fibromyalgia

First degree heart block, see Arrhythmia

G

Glaucoma

Glomerulonephritis, see Renal disease

Goodpasture syndrome, see Severe or systemic autoimmune disease

Graves disease, see Single organ autoimmune disease

Guillain-Barre syndrome, see Severe or systemic autoimmune disease

Gout

H

Haemoglobin disorder

Haemophilia (any type), see Bleeding disorders

Hashimoto thyroiditis, see Single organ autoimmune disease

Hayfever, see Allergy

HbC, HbD, HbE, HbO, see Haemoglobin disorder

Heart attack, see Coronary artery disease

Heart block, see Arrhythmia

Heart murmur, see Valvular heart disease

Heparin therapy, see Bleeding disorders

Hepatitis B

Hepatitis C

Hereditary haemorrhagic telangiectasia, see Bleeding disorders

Herniated intervertebral disc, see Back complaints

Herpes simplex virus

High affinity haemoglobin, see Haemoglobin disorder

High blood pressure, see Hypertension

High risk sexual behaviour

HIV

Hormone replacement therapy, see Prion-associated disease

HSV, see Herpes Simplex Virus

HTLV infection

Hypertension

Hyperthyroidism, see Single organ autoimmune disease

Hypothyroidism, see Single organ autoimmune disease

I

IgA nephropathy, see Renal disease

Immune thrombocytopenia, see Bleeding disorders

Implantable cardiac defibrillator (ICD), see Arrhythmia

Inflammatory bowel disease, see Severe or systemic autoimmune disease

Inflammatory eye disease

Innocent murmur, see Valvular heart disease

Injection of non-prescription drugs

Innoculation injury

Iridocyclitis, see Inflammatory eye disease

Iritis, see Inflammatory eye disease

Ischaemic heart disease (IHD), see Coronary artery disease

J

Jugular vein thrombosis, see Thrombosis and Thrombophilia

K

Kidney stones, see Renal disease

L

Latex allergy, see Allergy

Left bundle branch block, see Arrhythmia

Long-QT syndrome, see Arrhythmia

Lown-Ganong-Levine syndrome, see Arrhythmia

M

Malaria

Malignancy

Manic depressive disorder, see Bipolar affective disorder

Marburg, see Viral haemorrhagic fever

Mitral regurgitation, see Valvular heart disease

Mitral stenosis, see Valvular heart disease

Mitral valve prolapse, see Valvular heart disease

Multiple sclerosis, see Severe or systemic autoimmune disease

Murmur, see Valvular heart disease

Myalgic encephalomyelitis (ME)

Myocardial infarction (MI), see Coronary artery disease

N

Needlestick injury, see Innoculation injury

Nephrectomy, see Renal disease

Nephritis, see Renal disease

Nephrolithiasis, see Renal disease

Nephrotic syndrome, see Renal disease

O

Osler-Weber-Rendu syndrome, see Bleeding disorders

Oral anticoagulant therapy, see Bleeding disorders

Osteoporosis

Overweight, see Weight

P

Pacemaker, see Arrhythmia

Paget-Schroetter syndrome, see Thrombosis and Thrombophilia

Pernicious anaemia, see Single organ autoimmune disease

Paroxysmal nocturnal haemoglobinuria (PNH), see Thrombosis and Thrombophilia

Pneumothorax

Portal vein thrombosis, see Thrombosis and Thrombophilia

Pregnancy

Prion-associated disease

Prolapsed intervertebral disc, see Back complaints

Protein C deficiency, see Thrombosis and Thrombophilia

Protein S deficiency, see Thrombosis and Thrombophilia

Prostitution, see High risk sexual behaviour

Psoriasis, see Single organ autoimmune disease

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

Pulmonary regurgitation, see Valvular heart disease

Pulmonary stenosis, see Valvular heart disease

Q

R

Renal colic, see Renal disease

Renal disease

Renal vein thrombosis, see Thrombosis and Thrombophilia

Retinitis pigmentosa

Rheumatoid arthritis, see Severe or systemic autoimmune disease

Right bundle branch block, see Arrhythmia

S

Sarcoidosis, see Severe or systemic autoimmune disease

Sciatica, see Back complaints

Scleritis, see Inflammatory eye disease

Scleroderma, see Severe or systemic autoimmune disease

Second degree heart block, see Arrhythmia

Seizure, see Epilepsy

Sex worker, see High risk sexual behaviour

Severe or systemic autoimmune disease

Sickle cell disease, see Haemoglobin disorder

Sickle cell trait, see Haemoglobin disorder

Single organ autoimmune disease

Sinus bradycardia, see Arrhythmia

Sinus tachycardia, see Arrhythmia

Spinal stenosis, see Back complaints

Spondylitis, see Back complaints

Spondylolisthesis, see Back complaints

Stroke, see Cerebrovascular disease

Supraventricular tachycardia, see Arrhythmia

Surgery

SVT, see Arrhythmia

Syphilis

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

T

Tattoo, body piercing and acupuncture

Thalassaemia, see Haemoglobin disorder

Thrombosis and Thrombophilia

Thrombotic thrombocytopenic purpura (TTP), see Severe or systemic autoimmune disease or Bleeding disorders

Thyroid disease, see Single organ autoimmune disease

Toxoplasmosis

Transfusion

Transient ischaemic attack (TIA), see Cerebrovascular disease

Tuberculosis

U

Ulcerative colitis, see Severe or systemic autoimmune disease

Underweight, see Weight

V

Valvular heart disease

Ventricular tachycardia/fibrillation, see Arrhythmia

Viral haemorrhagic fever

Vitiligo, see Single organ autoimmune disease

Von Willebrand disease (vWD), see Bleeding disorders

Vitamin K deficiency, see Bleeding disorders

W

Warfarin therapy, see Bleeding disorders

Wegener granulomatosis, see Severe or systemic autoimmune disease

Weight

Wenckebach (Mobitz I) heart block, see Arrhythmia

West Nile Virus

Whiplash, see Back complaints

X

Y

Z

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