Parents who wish to store the stem cells of their child for at least twenty years have the need to entrust to a company able to guarantee long solidity, reliability and transparency. The value of stem cells is so high that there is a need of careful warranties evaluation and liability limitations that the company, providing the service, offers.
The only and real guarantees that a company can offer to its customers consist in the resources made available for the performance of its business (investments, capital, corporate structure). Bioscience Institute has a direct relationship with its customers and does not outsource its services neither rely on commercial companies that would not be able to offer its own warranties.
A stem cell transplant is an extremely delicate and risky operation which is conducted in specialised centres. If the stem cells are not correctly preserved, the patient’s life could be at risk. This is why there are international certifications which guarantee that the cells are correctly handled in sterile environments, especially if they are being stored to be used for humans.
In Europe, before a transplant, the Centres in charge run a check on the origin of the biological material to be transplanted. If the laboratory in question has not been awarded an internationally-acknowledged certificate, it will not be possible to transplant the stem cells because they do not offer the necessary biological safety and traceability guarantees.
GMP (Good Manufacturing Practice)
Legislative Decree n.16 from 25/01/2010 defines “quality and safety standards for donation, procurement, control, preservation, storage and distribution of human tissues and cells to the health centre where these will be grafted onto the human body”; reference is made exclusively to GMP (Good Manufacturing Practice), as stipulated by the European Guide to Good Manufacturing Practices.
Companies which have obtained the GMP certification have made a substantial investment, sustain very high management cost and are in a position to submit the relevant certificate.
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).
Stem cells destined to a long-term preservation should be placed in a temporary storage container, where they remain in "quarantine" until the final analysis, required by current regulations, give negative results. Only at the end of the so-called quarantine period, it is possible to transfer the cells from the temporary container to the permanent storage.
The quarantine is a mandatory requirement by law, failure to observe the period of quarantine makes the preserved cells unusable because they are lacking the requirement of "biosafety".
In order to maintain the cells vitality, the company offering the service of cryopreservation must preserve the stem cells during transport and ensure their freezing within 72 hours of delivery.
The kit used for transportation must provide adequate protection of the cord blood sample (unlikely with a simple cardboard box), the withdrawal of the kit must be made promptly and delivery at the laboratories must be completed within the shortest possible time. Problems related to distance and accessibility of laboratories, especially in case of holidays and strikes, could affect the vitality of the cells and their usability as a consequence.
The kit should be resistant to:
► Shocks and perforations (the wrapper must be rigid)
► Changes in temperature (so it must be insulated)
► Contaminations (double sealed container)
► Tampers (must have a padlock)
► Changes in environmental pressure (pressure control valve)
► Flooding (must be sealed)
The kit should be easily visible, identifiable and comply with the procedure PI 650 IATA UN 3373, as required by the Ministry of Health Circular 16 dated 20 July 1994 ("Recommendations for the safe transport of infectious substances and diagnostic specimens" ), the Circular of the Ministry of Health # 3 of 8 May 2003, in accordance with the Ministerial Ordinance of May 4, 2007 and the regional regulations.
The company that offers the service of cord blood cryopreservation must ensure the usability of stem cells in the case of transplant. The high standards of quality and biological safety that must be offered laboratories must also match with appropriate storage procedures, as required by strict protocols GMP (Good Manufacturing Practice). Stem cells stored in different way (not according to GMP procedures) may not be used for possible transplants.
For example, the preservation of the stem cells of the same sample in two separate cavity is considered by international certification bodies as a lack of the basic guarantees of quality. This procedure, that does not comply with GMP protocols, increases by 100% the risk of contamination and compromises the quality and viability of the preserved biological material.
The double storage can be a communication topic of a great emotional impact but absolutely inappropriate from a scientific point of view, so as to represent a negative aspect to be considered in the evaluation of placental blood banks that adopt such procedures.
In this regard, on the website of Osidea NGO, it says: "We must also point out that those strange promoted formulas, where the unit is more or less divided into two or more parts, it is not scientifically correct for possible transplantation for therapeutic purposes. To proceed with a transplant there is a need of high number of stem cells. There is absolutely no sense to allocate 80% to heterologous donation and 20% to autologous conservation, in fact, the remaining 20% is not enough for a transplant. "