|
| | Risk factors or hazards | Identified risks |
| Stem cell therapy | PC therapy |
|
Intrinsic factors:
cell characteristics | (i) Origin of cells (e.g., autologous versus allogeneic, diseased versus healthy donor or tissue)
(ii) differentiation status
(iii) tumourigenic potential
(iv) proliferation capacity
(v) lifespan
(vi) long-term viability
(vii) secretion patterns (e.g., growth factors, cytokines, chemokines)
(viii) quality of cells
(ix) quantity of cells | (i) Rejection of cells
(ii) Disease susceptibility
(iii) unwanted biological effect (e.g., in vivo differentiation into unwanted cell types)
(iv) Toxicity
(v) Tumor formation (benign or malignant) | (i) Lower efficacy (e.g., obtained from donor on medication or donor who has activated platelets, thrombocytopenia, or coagulation disorders)
(ii) Exacerbation or metastasis of tumor |
|
Extrinsic factors:
manufacturing and handling | (i) lack of donor history
(ii) starting and raw material
(iii) plasma derived materials
(iv) contamination by adventitious agents (viral/bacterial/mycoplasma/fungal species, prions, parasites)
(v) cell handling procedures (e.g., procurement)
(vi) culture duration
(vii) tumorigenic potential (e.g., culture induced transformation, incomplete removal of undifferentiated cells)
(viii) noncellular components
(ix) pooling of allogeneic cell populations
(x) conservation (e.g., cryopreservatives)
(xi) storage conditions (e.g., failure of traceability, of human material labeling)
(xii) transport conditions | (i) Disease transmission
(ii) Reactivation of latent viruses
(iii) Cell line contamination (e.g., with unwanted cells, growth media components, chemicals)
(iv) Mix-up of autologous patent material
(v) Tumor formation (benign or malignant) | (i) Bacterial contamination due to poor operator skills
(ii) Irreversible inactivation of platelets at low temperature |
|
| Clinical characteristics | (i) therapeutic use (i.e., homologous or nonhomologous)
(ii) indication
(iii) administration route
(iv) initiation of immune responses
(v) use of immunosuppressants
(vi) exposure duration
(vii) underlying disease
(viii) irreversibility of treatment | (i) Undesired immune response (e.g., GVHD)
(ii) Unintended physiological and anatomical consequences (e.g., arrhythmia)
(iii) Engraftment at unwanted location
(iv) Toxicity
(v) Lack of efficacy
(vi) Neoplasm formation (benign or malignant) | (i) Lower efficacy (e.g., in diabetic patient) |
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