Guarantees

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.

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.

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”.

The shipment of cord blood to the Republic of San Marino (geographically integrated into the Italian territory) is constantly monitored according to a dedicated and specially designed logistics, does not require customs controls and allows flexible management of any problems related to holidays, strikes or climatic situations adverse.

The transport takes place on the “road” and, if necessary, a dedicated courier is activated which, without additional costs for the parents, guarantees the delivery of biological material to the institute within the time limits established by the Ministry of Health (“Guidelines for accreditation of umbilical cord blood banks “), irrespective of any adverse event. Once in the laboratory, the blood sample is analyzed and the cells are frozen.

The society that offers the cord blood cryopreservation service must guarantee the usability of the stem cells in case of transplantation. The high standards of quality and biological safety that laboratories must offer must also be matched with appropriate conservation procedures, according to the strict GMP (Good Manufacturing Pratice) protocols.

Stem cells stored in ways other than GMP procedures can not be used for transplants.