1
Supplement Table 3:Medical conditions, donor suitability and individuals at risk
Condition / Donor Suitability / Generally not recommended / RiskforPulmonarydisease
Asthma / topical treatment with inhalers / oral or i.v. corticosteroids / R/D
Chronic bronchitis with or without emphysema, bronchiectasis, chronic obstructive pulmonary disease, emphysema, cystic fibrosis, loss of lung (incl. lobectomy) / if well controlled / attacks of coughing or dyspnea at rest / D
Gastrointestinal disorders
Gastroesophageal reflux, Peptic ulcer disease, Irritable bowel syndrome / in absence of active bleeding and stable under treatment, mild impact on daily living / ongoing or / D
Celiac disease / in absence of active bleeding and stable under treatment, mild impact on daily living / ongoing or poorly controlled / R/D
Diverticulitis/diverticulosis / completely recovered / ongoing or poorly controlled / R/D
Ulcerativecolitis, Crohn’s disease / no inflammation, no immunosuppressants >3 mos / inflammation, immunosuppressants / R/D
Non-infectious liver, biliary tract, spleen, pancreatic disorders
Hereditary hemochromatosis
Elevated liver enzymes
Wilson's disease
Cirrhosis
Sclerosing cholangitis
Splenectomy
Splenomegaly
Chronic pancreatitis / fit for blood donation, Child-Pugh A
depending on cause
Child-Pugh A
Child-Pugh A
Child-Pugh A
depending on cause
depending on cause
depending on cause / Child-Pugh B+C, organ dysfunction
temporally; if associated with infection
Child-Pugh B+C, organ dysfunction
Child-Pugh B+C, organ dysfunction
Child-Pugh B+C, organ dysfunction
-
(avoid physical strain during G-CSF)
organ impairment / D
D
D
D
D
D
D
D
Kidney and genitourinary tract disorders
Acute renal failure
Chronic renal failure
associated with systemic disease
Glomerulonephritis
Polycystic kidney disease
Nephrectomy due to disease
Nephrectomy due to injury / recovered
no other contraindications
not suitable
recovered
normal kidney function, normal BP
disease without contraindication
normal kidney function / ongoing
kidney function <30ml/min
donation not recommended
ongoing, kidney function <30ml/min
cerebral aneurysm
disease with contraindication
- / D
R/D
D
D
D
D
D
Cardio-, cerebrovascular, peripheral vascular diseases
Arterial hypertension, Hypotension
Coronary heart disease
Disturbance of heart rate and rhythm
Congestive heart failure, Cardiomyopathy
Valvular heart disease
Pericarditis, Myocarditis
Cerebrovascular disease, stroke
Atherosclerotic peripheral vascular disease
Aortic aneurysm
Cardiac surgery for congenital heart disease / use ASA-PS classification and ESC/ESA and ACC/AHA guidelines for pre-donation assessment / ASA-PS ≥3 / D
Non-infectiouseyediseases
Uveitis/iritis/scleritis
Glaucoma
Age related macular degeneration,Retinitis pigmentosa
Corneal transplant / recovered
well controlled
suitable
according to national guidelines1 / acute inflammatory process
instable situations
-
according to national guidelines1 / R/D
D
None
R
Hematological and oncological diseases
Anemia, relevant (>2g/dL below lower normal limit)
Pernicious anemia
Hemolytic anemia2
…autoimmune
RBC abnormalities:
G6PD deficiency
Spherocytosis/elliptocytosis / mild, corrected
corrected
recovered (infectious, drug)
resolved
not suitable
not suitable / underlying condition is contraindication
ongoing, other contraindications
not recommended
not recommended / D
D
D
R/D
R
D
Hemoglobinopathies:
Sicklecellanemia
Sicklecell trait
Thalassemia trait
Alpha thalassemia
Beta thalassemia / not suitable
suitable
suitable
minor
minor (only BM) / not recommended
avoid G-CSF
if other contraindications
major
major / R/D
D
R
R/D
R/D
Neutropenia, lymphocytopenia without underlying condition
Leukocytosis, lymphocytosis, neutrophilia / depending on cause
no other contraindication / <1.0x109 neutrophils/L or
< 0.5x109 lymphocytes/L
other contraindication / R/D
None
Monoclonal B-cell lymphocytosis (MBL)
M-protein, monoclonal paraproteinaemia / not suitable in confirmed clonality / confirmed clonality
if persistent >3 months / R
Bleeding diathesis: VWD, other hemophilia
Hemophilia / controlled by replacement
carriers, FXII deficiency, after replacement / acquired hemophilia and/or bleeding diasthesis
uncontrolled / D
Plateletdisorder
Primary immune thrombocytopenia (ITP)
Secondary immune thrombocytopenia (ITP)
Platelet abnormalities, low platelet count
Venousthromboembolism VTE
Hereditary thrombophilia without VTE / Resolved
resolved
PBSC platelets>100G/L or BM
PBSC platelets>100G/L or BM
<2 episodes in 12 mos, no cancer
with prophylaxis for VTE / excessive bleeding, bruising symptomatic, chronic ITP
no PBSC if PLT <100G/L
no PBSC if PLT <100G/L
≥2 episodes in 12 mos, contraindication / R/D
R/D
D
R/D
D
D
Malignancies3
Presence or previous history (≤5-10 yrs)except below
Cervical non-invasive (carcinoma in situ)
Skin non-invasive (primary basal cellcarcinoma)
History of invasive cancer in remission for >5-10 yrs / not suitable3
suitable
suitable
consider if low risk of transmission(see text) / not recommended
if no other contraindications
if no other contraindications
not recommended if ≥intermediate risk of transmission(see text) / R
Immunodeficiencies / recovered / primary or acquired / R/D
Autoimmune disorders
Ankylosing spondylitis
Antiphospholipid antibody syndrome4
Arteritis cranialis (temporal arteritis)
Cogan syndrome
Dermatomyositis, Polymyositis
Multiple sclerosis/Opticneuritis
Systemic lupus erythematosus (SLE), Scleroderma, Sjögren syndrome
Thromboangiitis obliterans (Buerger's disease) Vasculitis syndromes / not suitable / not recommended / R/D
Behçet's disease
Myasthenia gravis
Polymyalgia rheumatic
Raynaud's phenomenon/disease / mild
well controlled
moderate, topical treatment
no treatment required / in systemic disease
>5mg prednisolone, immunosupp.
BM in symptomatic cases
multi-systemicdisorder, vasodilators / R/D
R/D
D
R/D
Graves’ disease
Hashimoto thyroiditis / euthyroid, 6 mos after radioiodine or 1 month after thyreostatic drugs
controlled, euthyroid / uncontrolled
uncontrolled / R/D
Atopic dermatitis
Psoriasis5 / topical treatment only
topical treatment only / severe, systemic therapy
severe disease, steroids, etretinate, immunosupp., UV / R/D
Autoimmune hepatitis / asymptomatic, no immune-suppressants >3 mos / in active disease / R/D
Arthritis (rheumatoid, psoriatic, other) / mild, under NSAIDs only, BM only / PBSC (G-CSF trigger) / R/D
Diabetes mellitus type I6 / controlled, no late effects / if other contraindications / R/D
Other musculoskeletal diseases
Fibromyalgia
Osteoporosis
Osteomyelitis
Back/spine pain
Muscular dystrophy
Malignant hyperthermia / mild, consider BM
asymptomatic, for PBSC only
clearance of infection
for PBSC only
for PBSC only
for PBSC only / severe
BM
active disease
BM if herniated/slippeddisc
BM (anesthesia)
BM (anesthesia) / D
Allergies and allergic reactions
Reactions other than anaphylaxis (including latex)
Anaphylactic reactions (other than latex)
Reactions to acid-citrate-dextrose / agent is known & prevented
agent is known & prevented
for BM only / R/D
R/D
D
Endocrine and metabolic diseases
Diabetes mellitus type II
Gout
Hyperlipidemia
Obesity / controlled
BM preferred
no other contraindications
BMI ≤40 / late effects with increased risk
symptomatic cardiovascular disease
if other contraindications / R/D
D
D
D
Addison disease
Cushing’s syndrome
Growth or gonadotropin hormones
Hyperthyroidism
Hypothyroidism
Hyper-, Hypoparathyreoidism7
Polycystic ovarian syndrome
Multiple endocrine neoplasia / asymptomatic, controlled
iatrogenic and resolved
inform TC and patient
euthyroid, 6 mos after radioiodine or 1 month after thyreostatic drugs
controlled, euthyroid
asymptomatic
suitable
not suitable / if other contraindications
endogenous cause
late effects with increased risk
not recommended / D
D
R
R/D
D
D
None
R
Neurological disorders (except cerebrovascular disease)
Bell's Palsy
Cerebral palsy
Chargot-Marie Tooth disease
Communication difficulties
Creutzfeldt-Jakob disease:
incl. sporadic, familial and classic type
Variant Creutzfeld-Jakob Disease
Dementia
Disabled donor
Epilepsy/seizures
Essential tremor (benign)
Guillain-Barre Syndrome
History of meningitis/encephalitis
Huntington's Chorea
Meniere's Syndrome
Mentally handicapped
Migraines
Narcolepsy
Paraplegia
Tetraplegia
Parkinson's disease
Peripheral neuropathies (not immunological)
Tourette Syndrome
Vertigo / fully recovered or stable
suitable if comprehend
if handicap allows donation
not suitable
not suitable
able to understand process
if handicap allows donation
well controlled, fitness to drive
if no interference with collection
fully recovered
fully recovered
gene carriers only
suitable
able to understand process
suitable
suitable
suitable
not suitable
not suitable
if systemic disorder excluded
suitable
suitable / not recommended
not recommended
symptomatic: not recommended
not recommended
not recommended / R/D
D
R/D
D
R
R
R
D
D
D
D
None
None
D
D
None
None
None
D
D
D
None
D
None
Psychological-psychiatric disorders8
Anxiety disorders
Attention deficit disorder
Attention deficit hyperactivity disorder
Bipolar disorders9
Depression
Eating disorders (anorexia and/or bulimia)
Multiple personality disorder
Obsessive-compulsive disorder
Prior history of suicidality
Psychosis
Substance abuse other than i.v.
Unexplained or chronic fatigue syndrome / well controlled
well controlled
well controlled
well controlled
well controlled
BMI >16
well controlled
stable, assessed by psychiatrist
after cessation of use
suitable / BMI ≤16
not recommended
not recommended / D
Substance abuse i.v. / suitable if on substitution / active i.v. abuse / R/D
Suitability criteria for pregnant and breastfeeding women
Pregnancy
Breast feeding / not suitable
breast feeding has to be paused / fetus
infant
ACC=AmericanCollege of Cardiology, AHA=AmericanHeartAssociation, ASA=American Society of Anesthesiologists Physical Status, BMI=body mass index, BM=bone marrow, BP=blood pressure, D=donor, ESA= E European Society of Anaesthesiology, ESC= European Society of Cardiology, F=factor, immunosupp.=immunosuppressant, incl.=inclusive, i.v.=intravenous, mos=months, NSAID=non-steroidal anti-inflammatory drug, PBSC=peripheral blood stem cells, PLT=platelets, R=recipient,UV=Ultraviolet therapy, VWD=von Willebrand disease, VTE=venous thromboembolism, yrs=years
1Donors are ineligible according to the European law (EC 2006/17) but eligible at the earliest 12 months after transplantation and full recovery in Canada.
2 Individuals with a history of auto-immune hemolytic anemia are suitable if disease has resolved and no other underlying disease precludes donation.
3 According to the European legislation (EC 2006/17) the presence, or previous history of malignant disease, except for primary basal cell carcinoma, carcinoma in situ of the uterine cervix, and some primary tumors of the central nervous system that have to be evaluated according to scientific evidence, leads to an exclusion of the donor.
4Antiphospholipid antibody syndrome leads to thrombosis due to an autoimmune, hypercoagulable state caused by antiphospholipid antibodies.
5 Insevere disease, or during systemic therapy,e.g. steroids, ultraviolet therapy, immunosuppressive agents or etretinate (half-life of 120 days), HSC donation is generally not recommended. Recommendations regarding the latency period are divergent, but a deferral period after the last dose of acitretin or isoretinoin (half-life of 50 hours) of 6-12 months and after other immunosuppressive agents like calcineurin-inhibitors (half-life between 6 and 20 hrs.) of 3-6 months or steroids of 1 month is advisable.
6 Individuals with well-controlled DM type I are suitable if there is no evidence of late effects increasing their risk for donation.
7Individuals are suitable for BM and PBSC donation if they are asymptomatic (normal calcium levels and bone density) and parathyroid function is controlled. In case of osteoporosis donors are only considered suitable for PBSC collection.
8In donors with selected psychiatric disorders (e.g. anxiety, depression and bipolar disorders) HSC harvest and cryopreservation should be considered in advance before the conditioning regimen is started.
9Subjects with depression and bipolar disorders are suitable if their disease is well controlled, on stable maintenance treatment and not clinically impacting on behavior when giving consent or donating.In individuals on lithium excess leukocyte elevation in combination with G-CSF has been observed (personal communication W. Navarro). Therefore BM donation might be preferred to PBSC collection.