The homogenized amniotic membrane provided by FBTV is pure fragmented membrane suspended in
sterile saline solution (for injectable use).
Used in many specialities in cases of:
The human amniotic membrane is a unique, thin, collagenous membrane derived from the submucosa of the placenta, the area where the human foetus grows and develops. It is made up of layers of collagen including: basement membrane and stromal matrix. The amniotic membranes used for clinical applications come from placentas harvested only from elective caesarean sections following careful selection of the donor, who has consented to the donation, in accordance with tissue quality and safety regulations.
In addition to standard screening including: anti-HIV 1/ HIV 2, anti-HCV, HBsAg, anti-HBc, anti-HBs, anti-Treponema pallidum, anti-HTLVI/HTLVII, HBV-DNA, HCV- RNA, HIV-1 RNA,
additional Ac anti-Toxo IgG and IgM and Ac anti-CMV IgG and IgM tests are performed. Microbiological screening and, if deemed necessary, additional tests are also performed on each donor and tissue.
The homogenised amniotic membrane is preserved at -80°C Amniotic tissue is not immunogenic and does not elicit a substantial immune response; in vitro and in vivo studies or literature data have demonstrated the absence of immunogenicity.
Aliquots of homogenised amniotic membrane are prepared.
aliquots with BSS (balanced solution) or sterile saline for injection and stored in polyethylene or borosilicate glass vials. In these two cases, the homogenised membrane aliquots are frozen at -80° C for up to 2 years.
The tissue is sent frozen in a container with dry ice, athermic, certified to ensure temperature maintenance during transport. The shelf life of tissue distributed and maintained at a temperature of -70°C/-80°C is 2 years from the date of collection. Once thawed, they must be used within 7 days. The Bank guarantees proper storage until receipt of the tissue; in the event of any problems occurring during transport, the user must notify FBTV immediately.
All tissues distributed to implantation centres are accompanied by documentation describing: suitability of the donor, origin and characteristics of the tissue, expiry date, serological and microbiological tests performed, method of preservation, specific instructions for preservation and implantation, documentation for follow- up of the implanted tissue.
Each tissue must be used for a single patient.
Homogenised amniotic membrane is processed according to strict protocols, as required by Italian and European regulations. Laboratory activity takes place in environments classified as Grade A according to the European Guide to Good Manufacturing Practices (GMP), the classification of the environments is verified with continuous checks in order to minimise the risk of contamination. Membranes are morphologically assessed, immersed in antibiotic solutions and not subjected to radiation treatment to avoid damage. Once decontaminated, the membrane is approved under aseptic conditions and immersed in BSS (for ophthalmic use) or sterile saline (for injectable use).
Quality and safety are guaranteed:
and during processing with grading according to a
defined scale;
antibiotic treatment for 24-48h at +2°C/+8°C;
The clinical use of human tissue offers important benefits for recipients. Like any product of human origin, their use is not without risks, although these are rare. A control system is needed to ensure traceability and identification of the tissue at any stage of the process, from donation to recipient. Each tissue is identified with a unique code to allow traceability from origin to destination. Once the tissue is transplanted the code must be attached to the recipient’s medical history. FBTV must be informed when the tissue has been transplanted, through the completion of the “Traceability Card” attached to the tissue. The bank must be informed if the tissue has not been implanted.
If there is suspicion or evidence of a serious adverse reaction or an effect in the recipient possibly related to the safety and quality of the transplanted tissue, the physician should contact immediately and complete the ‘Rapid Notification of Suspected Serious Adverse Events of Suspected Serious Adverse Events” or “Rapid Notification of Suspected Serious Adverse Reactions”.
FBTV is registered on the list of Tissue Banks accredited by the National Transplant Centre; regulated activities include donation, collection, evaluation, preparation, preservation and distribution of homologous tissues. It operates in compliance with international standard ISO 9001:2015 and has a certification process in place to certify that tissues meet predefined safety, traceability and morphological requirements. Homologous tissues procured, processed, stored and distributed meet the requirements of Italian legislation (Law 91/99, Legislative Decree 191/97, Legislative Decree 15/11/2016, Legislative Decree 256 16/12/2016, State/Regions Agreement 66/CSR 8/3/2018) and European Directive 2004/23 and Directives 2006/17/EC, 2006/86/EC, 2012/39/EU, 2015/565/EU, 2015/566/EU. FBTV follows the standards of the main scientific associations: European Association of Tissue Banks (EATB), American Association of Tissue Banks (AATB), and the recommendations of: Good Tissue Practices (Euro-GTP) and the Council of Europe EDQM Guide to the quality and safety of tissues and cells for human application.
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