To store the stem cells for autologous use in Bioscience Institute it is necessary to obtain the authorization for exportation of cord blood.
How to obtain the Authorization:
1. contact the Health Department where the birth will take place to verify the procedure to be followed
2. make ALL the exams listed below on the basis of information received by the Health Department
3. go to the Health Department issuing the Authorization and bringing the results of the tests marked with an asterisk * and the Certification of conformity of the kit.
Examinations to be performed strictly in the last 30 days of gestation:
a. Anti HIV 1 e 2*
b. Anti HCV (epatite C)*
c. HBsAg (epatite B)*
d. Anti-HBc (IgG) * e Anti-HBc (IgM) *
e. TPHA (sifilide)
f. Anti- HTLV 1e 2 (virus Linfotropo dei linfociti T)
Please remember that the current legislation expects the execution of ALL the above tests, the results of which are to be provided in the original to Bioscience Institute.
If you have not already done so, with the start of the administrative practices we advise you to ask for the collection kit by calling Bioscience Institute (toll-free: 800 985 177), or by filling out the online form on our website.
In order to use the services offered by Bioscience Institute, call the free phone number and ask for the kit, which will be delivered by courier with the necessary documentation. The kit also includes the instructions and forms officially required from Italian citizens in the case of autologous preservation of stem cells. The Bioscience Institute staff will assist you in the administrative procedures to obtain the Export Authorization; the scientific staff, in turn, will provide you with all information concerning the therapeutic use of stem cells and the most recent developments in scientific research.
THE COLLECTION KIT
Airtight isothermal bag made of plastic resin, equipped with a pressurization valve, internally lined with expanded polyurethane, containing:
- agli urti e alle perforazioni (quindi l'involucro deve essere rigido)
- alle escursioni termiche (quindi deve essere coibentato)
- alle contaminazioni (doppio contenitore ermetico)
- alle variazioni di pressione ambientale (valvola di pressione)
- agli allagamenti (deve essere a tenuta stagna)
IL KIT DEVE ESSERE RESISTENTE:- Shock and perforations (then the housing must be rigid)
- To temperature (so it must be insulated)
- Contaminations (double airtight container)
- To changes in environmental pressure (pressure valve)
- To flooding (it should be airtight)
It must also be in accordance accordance with the procedure PI 650 IATA UN 3373, as required by the Circular of the Ministry of Health n. 16 of 20 July 1994 "Recommendations for the safe transport of infectious materials and diagnostic samples" and the Circular of the Ministry of Health n. 3 and 8 May 2003 in respect of 'Ministerial order of 4 May 2007 and regional regulations and must be easily visible / identifiable.
Although currently there is no clinical evidence regarding a possible therapeutic use, Bioscience Institute carries out, on the request of its customers, the preservation of a segment of the cord tissue collected at childbirth.
The cord tissue, sent to the laboratories in Bioscience Institute using the kit, is prepared under sterile conditions and frozen according to validated protocols.
In case of future therapeutic need, the isolation of mesenchymal stem cells contained in the tissue and their expansion in GMP conditions may be required.