Tissues of human origin do not fall into the medical devices category and cannot be sold for profit. It is strictly forbidden by the Italian legislation to sell or trade human organs and tissues for profit.
The Law n°91 of April 1st, 1999, art. 19 quotes “it is strictly forbidden to export organs and tissue to any State involved in free trade of human organs and tissue for profit”. And follows with the warning of sanctions for those who gain profit from trading organs and tissue.
Tissue can be requested without any additional fee other than the refund of basic costs. There is no need to ask for a quotation or offers, you can directly refer to the national tariff.
You can consult the Price List in our reserved area, with all the available products enlisted.
The data sheet of the tissues can be downloaded in the attachments. Data Sheet Sample:
- Product description
- Type of processing
- Available size
- Product Code
- Clinical application
- Type of packaging
- Shipment modality
- How the quality of donation, tissue and management is guaranteed
- Sterilisation applied
- Chemicals applied in the process
- What to do in case of adverse reaction/event
Types of processed tissue
The product is kept frozen at -80°C until the expiry date. Alternatively kept at -20°C for 6 months from delivery. Once the tissue is thawed for use it must not be refrozen.
Lyophilisation (Freeze-drying) involves dehydration through the sublimation of ice at low pressure. The process is carried out and monitored by an automatic Freeze Dryer. The efficacy of such a procedure is evaluated by the measurement of the residual water, which must be under 5%. The tissues undergoing this procedure are put under sterile packaging and must be kept at room temperature, in a cool dry place, away from direct light or heat source until the expiry date.
The tissue is ground and chemically treated for sterilisation, then demineralised with specific solvents, refrozen and freeze-dried. The final packaging will contain demineralised bone matrix DBM, from a single donor.
Malleable, thermoplastic and osteoinductive paste, obtained by mixing collagen, sterile water, demineralised bone matrix DBM and a specific biocompatible thermoplastic polymer. The collagen guarantees a quick adhesion of the cellular component, the DBM carries osteoinductive factors and is the bioactive component of the paste, and the polymer adds to the paste an inverse thermoplastic property by increasing viscosity at 37°C. The bone paste can be mixed with morselised bone to give osteoconductive properties, and/or with autologous material (blood, bone marrow concentrate, bone shaving) to increase osteogenic properties.
Osteochondral fresh tissues are harvested upon request, in a culture medium mixed with broad-spectrum antibiotics. The tissues are kept at +4°C away from direct light. This allows the maintenance of optimal cellular viability up to 21 days from procurement, the final term for transplant.
Tissue for Massive Grafts
The grafts are used for massive bone transplants, to substitute large portions of bone, and to create an optimal anatomic and functional substitution. Massive grafts have osteoconductive properties acting as scaffolds by facilitating the insertion of blood vessels and bone growth, giving structural support. They are frozen at -80°C, this allows the maintenance of biomechanical abilities, specifically load resistance, torsion and flexion depending on the type of graft.
Soft Tissue (tendons, menisci)
Solely harvested by cadaver donors under 65 years of age, or as for meniscus, the age threshold is 55 years. Must be frozen at -80°C as quickly as possible to maintain biomechanical abilities, specifically resistance to torsions and/or flexion. Quick freezing also suppresses cellular viability and reduces the capacity of the tissue to generate an immune response, to a minimum.
Cartilage is obtained from the ribcage, removing the tissue from the VI to X rib from a donor under 55 years of age. The effective presence of an adequate cartilaginous component needs to be verified. Cartilage is either treated with alcohol or frozen. The choice is at the surgeon's discretion.