Guarantees offered by the Bioscience Institute for the umbilical cord storage service.

The value of stem cells makes it essential to carefully evaluate the guarantees and limits of liability of the company offering the service. The Bioscience Institute guarantees quality, solidity, reliability, and transparency.

Guarantees: solidity

The only real guarantees that a company can offer to its customers consist of the resources made available for the performance of its business and the maintenance of quality, with which it actually and directly responds (investments, share capital, corporate structure).

The Bioscience Institute has a direct relationship with its customers, does not outsource its services and does not make use of commercial companies that would not be able to offer its own guarantees, and contractually undertakes to maintain its quality standards unchanged for the entire duration of the contract.

Guarantees: quality

The Bioscience Institute has chosen to comply with the GMP (Good Manufacturing Practice) standard to offer the guarantee that stored stem cells can be accepted and used, if necessary, even in GMP certified transplant centers, which would otherwise reject them. Through compliance with GLP (Good Laboratory Practice), ISO (UNI EN ISO 14644 – 1/2/3/5 and UNI EN ISO 14698 – 1-2) and LBM (Laboratory Biosafety Manual WHO FDA) certifications, it intends to make use of all the methods and controls necessary for guarantees and to guarantee maximum safety in carrying out their business.

More information on the GMP standard

Stem cell transplants are very delicate and risky operations that are carried out in a transplant center that is specialized in the disease to be treated; the use of improperly stored stem cells can compromise the outcome, jeopardizing the patient’s life. For this reason, there are quality standards that guarantee the correct processing procedures for cells in sterile environments, if they are intended for use on humans.

The authorized structures are obliged to verify the safety and traceability of the biological material to be transplanted; these requirements are complied with if the laboratory from which the stem cells originate adopts an internationally recognized quality standard (for example GMP – Good Manufacturing Practice).

Read the Legislative Decree No. 16 of 25/01/2010 on page 16 (Annex V, letter D, point 3)

If the laboratory from which they originate does not comply with the GMP quality standard, the stem cells cannot be accepted and used by transplant centers, because they are considered to be biological material at risk. This would render conservation useless.

The laboratories that follow the GMP guidelines have invested significant resources in structures and safety equipment, and incur very high management costs to apply the operating procedures provided for by the GMP protocols.

Guarantees: quarantine

Quarantine is a mandatory requirement by law (Legislative Decree No. 16 of 2010) without which the stored cells would be unusable because they lack the biosafety requirement.

For this reason, the stem cells intended for storage are placed inside a temporary storage container, where they remain in quarantine until the final analyses required by current legislation have given a negative result. Only at the end of this period are the cells transferred from the temporary container to the final storage container.

Guarantees: transport

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

If necessary, a dedicated courier is activated, which guarantees the delivery of the biological material to the Bioscience Institute within the time limits established by the Ministry of Health (“Guidelines for the accreditation of umbilical cord blood banks”) regardless of any adverse event.

Guarantees: storage

Only stem cells stored according to GMP (Good Manufacturing Practice) procedures can be used for any transplants.
Precisely to ensure the usability of stem cells in the event of transplants, the Bioscience Institute combines the high standards of quality and biosafety offered by laboratories with appropriate preservation procedures, in accordance with strict GMP protocols.

Additional guarantees offered

Delivery of the Certificate of Cryopreservation

Parents who store umbilical cord blood stem cells receive a certificate of cryopreservation showing the characteristics of the sample (viability, stem cell number, white blood cell count, sterility).

No costs for sample transport and HLA typing

At the time of export (which given the high standards of conservation, can take place in any transplant center in the world) the Bioscience Institute assumes the costs and technical organization of the sample and HLA typing logistics.

Payment of the annual fee and option of renewal beyond the 20th year

The payment of an annual fee guarantees both long-term maintenance and the option, in the face of favorable clinical data, to renew the contract at the end of the twentieth year without having to incur new unknown costs to subscribe for maintenance.

Are you pregnant?

Are you thinking of storing your child's stem cells?

Cord blood is the blood that remains in the umbilical cord after the baby is born and is a valuable source of stem cells.

Until recently it was treated as “waste” and eliminated with hospital waste along with the placenta and the umbilical cord. It is currently used in the treatment of around 100 serious diseases.

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