Biomedical Engineering Reference
In-Depth Information
All materials must be checked in terms of sterility, apirogenicity and absence of contaminat-
ing agents.
Use of any substance that may induce immune response (animal serum, serum proteins,
antibiotics, antimicotic agents) should be avoided or limited to the very first manipulation
procedures; indeed these substances must be absent in the final product.
Specific attention should be posed to the use of fetal bovine serum, due to the serum-associated
risk of transmission of unknown pathogens. Ultimately the use of human serum, if necessary,
must be properly justified.
Donor/Recipient Selection
Donors can be living or deceased. Obviously, for composites that include autologous cells,
only living donors are considered. Donor files should include the following:
•
identity code for each donor;
•
name, age and gender; age should be limited, according to the most recent data available, to
ensure proper cell response;
•
health status;
•
date and time of the biopsy;
•
biopsy characteristics (procedures applied, size, purpose, conservation means). Logistic of
biopsy shipment (sending and receiving institutions, way of travel, etc) should also be re-
corded.
Donor/Recipient Exclusion Criteria
Donor's cells must be preventively addressed as for autologous or allogeneic use. Allogeneic
therapies are associated to a high potential risk of transmission of pathogens. Donors should be
excluded if:
• affected with extended infections or septicemia;
• positive to syphilis, type B hepatitis, type C hepatitis, AIDS (or if included in AIDS-risk
associated categories), HIV-I and/or HIV-II, Creutzfeldt-Jacob syndrome (CJD);
• affected with neurological diseases of viral or unknown origin;
• previously treated with the human growth hormone and/or drugs derived from the human
hypophysis;
• previously treated with dura mater;
• previously treated with demineralized bone; demineralized bone falls under a different regu-
latory panel, as described in a following paragraph;
• previously treated with bovine pericardium;
• affected with malignant tumor(s);
• affected with genetic diseases that may compromise the recipient tissue response to the
composite application;
All the donors/patients will repeat testing 6 months after inclusion in the protocols for
those pathologies for which a positive test response is not immediately detectable after infec-
tion. For a second screening, alternative tests may also be applied, such as the polymerase chain
reaction (PCR), if of proven validity.
Cells or tissues of donors found positive to exclusion criteria should not be acquired. If
acquired they should be destroyed. This rule may not apply to autologous transplantation
procedures or in rare cases of allogeneic therapies for which either the syndrome gravity or the
donor's genotype rarity make other therapeutic approaches unfeasible. In theses cases the com-
petent authority must also certify the conservation procedures of biological material explicitely
identified as “biohazardous”; all the procedures for the collection, disposal and conservation of
potentially biohazardous material must be described in detail prior to approval.
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