The CONTRACT of autologous cryopreservation signed with Bioscience Institute SpA is a contract stipulated by parents directly, without intermediaries, with the company owning the laboratories and systems of biological cryopreservation. This means that Bioscience Institute responds directly on its work, promising not to transfer to third parties the rights under the contract. Bioscience Institute, in order to ensure the reliability over time to its customers, undertakes a contractual obligation to maintain the level of quality of the procedures used and the structure in which it operates, through instruments objectively reliable as international certifications.
Why is it preferable that the company that signs the CONTRACT is the same that offers the service?
A contract, signed directly with the company that owns and manages its laboratories where the cells are preserved, allows to be in contact with a single party that is directly responsible for its work.
Why the opportunity to assign the rights to a third party is a risk for the company that signes the contract?
A contract that provides the opportunity for the company to transfer the rights arising from it to another company, or a third party, fails to protect adequately those who entrust their stem cells because it does not guarantee the characteristics of the company or the third party to whom the rights may be transferred.
If the contract is signed by an Italian company:
› It means that the company does not own the workshops but only an intermediary, because in Italy by law there can be no private banks of autologous stem;
› The contract is void, because in violation of the Law 219/2005 in Italy which prohibits any activity related to stem cells, including the business even when stored abroad;
› It is an Italian company that buys the service from foreign banks to sell in Italy.
Before signing a contract for cryopreservation of stem cells from umbilical cord make sure the biobank:
› Holds workshops, and it is not a commercial company or an intermediary;
› Can demonstrate with adequate certification safety standards are essential for the future use of the stored stem cells;
› Is able to ensure over time solidity and corporate finance (it is evident that a SpA offers more guarantees of a Srl).
We wish to highlight the importance of QUALITY, which should be paramount compared to economic elements when choosing the bank where stem cells are to be preserved.
In biological cryopreservation, complying with a high quality standard is the only way of preserving and handling stem cells from the cord to make sure that they can be used for a transplant. In the biotechnology sector QUALITY is a costly requirement, but it is essential in order to have adequate safety guarantees.
An economically advantageous proposal inevitably goes to the detriment of QUALITY.
Bioscience Institute is the only Cell Factory present in the Italian peninsula that deals with cryopreservation of stem cells. Bioscience Institute has obtained permission in 2007 to conduct its business in the territory of the Republic of San Marino by the competent Health Authority. The processing and cryopreservation of stem cells occur in compliance with the guidelines GMP (Good Manufacturing Practice), so as to ensure the highest quality and, consequently, their use at any transplant center in the world.
THE DIRECT MANAGEMENT
The stem cells are stored in the vault of the laboratories owned by Bioscience Institute and are not sent to other foreign companies of which parents may not have knowledge or direct vision.
In the case of Bioscience Institute, Parents enter into a contract directly with the company that owns the laboratory and is directly responsible for its work for the entire duration of the contract.
THE LAW FOR THE RE-IMPORTATION
The Italian and European law states that the re-importation into Italy of cells stored abroad (it makes no distinction in this regard between EU and non-EU) is possible only where the laboratory of origin has proper authorization or license to carry their business (granted by the State in which it operates) and is capable, documenting the high quality standards adopted, that the cells are preserved biologically safe and traceable.
IN CASE OF TRANSPLANTATION
Bioscience Institute, in the case of graft, provides a range of services included in the price of cryopreservation:
› a compatibility test (HLA typing)
› transportation of the cells at any transplant center (in Italy or abroad)
› the container for the transportation of the cells (DRY SHIPPER) in free loan
› the reimbursement (up to € 20,000.00) of any expenses incurred in carrying out the transplant and not covered by the National Health Service.
Bioscience Institute within the contract provides the possibility to extend the duration of storage, without having to renegotiate the terms. At the end of 20 years of conservation, where the utility is scientifically proven, it will be possible to extend the contract period, continuing to pay the annual fee of cryopreservation.
Bioscience Institute follows the parents in the procedure required to obtain from the Ministry of Health the Authorization to export the cells and for all subsequent phases, from collection to preservation.
Bioscience Institute arranges an overnight hotel stay for any couple who, starting from the fourth month of pregnancy, wishes to get a first-hand impression of its Staff’s professional skill and of the value of the laboratories dedicated to cryopreservation. It is possible to book a visit by e-mail or phoning our free phone number.
Il primo trapianto con cellule staminali del sangue cordonale è stato effettuato nel 1988 su un bambino affetto da Anemia di Fanconi (le cellule staminali sono state raccolte dal sangue del cordone della sorellina); solo dal 1990 ha avuto inizio la raccolta del sangue del cordone ombelicale per il congelamento finalizzato all'utilizzo futuro.
The international scientific literature is reporting that there have been successfully performed transplants on humans, using stem cells from cord blood stored for a period of 16 years. A recent study on animal models has shown that stem cells, preserved in nitrogen, retain their vitality for 23.5 years (hematopoietic stem/progenitor cells ).
Bioscience Institute offers the possibility to extend the contract, only on the basis of the scientific evidence demonstrated each time, continuing to pay the annual fee.