An opportunity that is valid for a lifetime – Secure your child’s future health with the most advanced stem cell banking service.
Preservation of Cord Blood Stem Cells
A Precious Resource Available Only at Birth
Stem cells are non-specialized cells characterized by unlimited proliferation potential and the unique ability to differentiate into the specialized cells of which tissues and organs are made.
Umbilical cord blood contains stem cells in the youngest and most potent form. These cells are not specialized and have a high proliferative potential in addition to the ability to differentiate the cells that compose the blood and its components. These cells – called “hematopoietic” – can be used therapeutically to treat blood-lymphatic disorders.
The only circumstances in which these precious cells, which have the ability to self-renew can be obtained, is at the time of a baby’s birth. Later, they can also be taken from the bone marrow but not without inferior therapeutic results.
Autologous and Private Conservation with Bioscience Institute
The activity of private stem cell banks has always contributed to raising awareness of the importance of conserving cord blood stem cells, whether public or private.
Over the years, in fact, requests for donations have increased or decreased when those for private conservation followed the same trend. Private banks, therefore, can integrate the activities of public banks, if they are able to provide, through a bioethical code and excellent quality standards, balanced information, and the necessary guarantees.
Source: National Blood Center
Why Store Cord Blood Stem Cells?
Stem cells can be used in the treatment of serious diseases. Therefore, storing cord blood is an investment in the health of your children and compatible family members. More than 1,400 clinical trials are currently underway to prove the efficacy of these cells and there are more than a thousand diseases that are analyzed and treated using these cells.
Proven Therapeutic Value
Storing cord blood stem cells is an investment in the health of your children and of compatible family members. The preserved cells can be used in the treatment of serious diseases. More than 40,000 stem cell transplants from umbilical cord blood carried out around the world for the treatment of many diseases confirm the importance and scientific validity of preservation.
A Limited Window of Opportunity
Unfortunately, today in Italy, where about 500,000 children are born per year, only 0.4% of available umbilical cord blood is stored in one of the Italian public banks. Private autologous banks keep less than 2%. This means that more than 97% of the umbilical cords that could be stored are, in fact, disposed.
Raising Awareness
Bioscience Institute and other private banks have always contributed to raising awareness of the importance of stem cell preservation, whether public or private.
Cord Blood vs. Cord Tissue
For more than twenty years it has been shown that hematopoietic stem cells, present in the blood of the umbilical cord, are endowed with a marked plasticity that makes them useful for the treatment of various diseases. From the cord tissue, it is possible to isolate mesenchymal adult stem cells. They are multipotent cells from which it is possible to obtain most of the types of cells present in the body and for this reason they find application in the therapeutic treatment of diseases that affect many organs and tissues.
When to Store Cord Blood Stem Cells
The possibility of using stem cells to treat a wide variety of diseases represents today one of the most important tools made available to humans by medical-scientific research.
By contacting a private biobank such as the Bioscience Institute, it is possible to store the stem cells present in the cord blood for preventive purposes, in the event that the newborn is affected by one of the diseases treatable with these cells, or for allogeneic purposes to let them be used by a compatible family member.
List of Diseases Treatable with Stem Cells
The list of diseases treatable with stem cells is constantly updated. In many cases these cells are used in approaches that are now considered standard; to these are added numerous cases in which stem cell-based therapies represent promising experimental treatments.
Diseases Currently Treated with Hematopoietic Stem Cells:
- Leukemia
- Myelodysplastic syndromes
- Lymphomas
- Anemias
- Hereditary disorders of the immune system
- Hereditary metabolic diseases
- Solid tumors
Diseases in Clinical Trials:
- Alzheimer’s disease
- Parkinson’s disease
- Stroke
- Autism
- Cerebral palsy
- Autoimmune diseases
- Cardiovascular disorders
- Diabetes and associated disorders
- Genetic and metabolic diseases
- Arthrosis
- Ankylosing spondylitis
- Damage to cartilage
- Erectile dysfunction
- Ovarian failure
Umbilical cord blood can be collected at the time of delivery, both from physiological and caesarean deliveries. Families wishing to do so must apply for the Export Authorization (approx. 30 days before the delivery) from the Health Department of the hospital where the child will be born. The Bioscience Institute deals with the administrative, logistical and health aspects, assisting its customers in the procedures necessary to obtain the Export Authorization and in the collection of the blood sample at the facility where the delivery will take place.
What Should Be Stored?
It is possible to preserve stem cells from both umbilical cord blood and the cord tissue. From umbilical cord blood it is possible to obtain and store hematopoietic stem cells to treat blood and lymphatic system disorders, while from the umbilical cord tissue it is possible to extract mesenchymal stem cells that can be used in the treatment of degenerative processes of human tissues and organs.
From Wharton’s jelly, a substance present in the cord tissue, it is possible to isolate adult mesenchymal stem cells. These are stem cells that differ from those of cord blood in terms of characteristics and potential for therapeutic use. The Bioscience Institute offers the option of conserving both umbilical cord blood stem cells and cord tissue stem cells.
Umbilical Cord Blood and Hematopoietic Stem Cells (HSCs)
Umbilical cord blood stem cells can be stored for the newborn or for allogeneic use by compatible family members. More than 40,000 transplants of stem cells from umbilical cord carried out around the world for the treatment of many diseases confirm the importance and scientific validity of preservation.
Reference: Ballen KK et al. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175
Umbilical Cord Tissue and Mesenchymal Stem Cells (MSCs)
The preservation of a segment of cord tissue collected at the time of delivery is carried out by the Bioscience Institute upon request by its customers. From Wharton’s jelly, a substance present in the cord tissue, it is possible to isolate adult mesenchymal stem cells. These are stem cells that differ from those of cord blood in terms of characteristics and potential for therapeutic use.
The Collection Procedure
The blood contained in the umbilical cord, rich in stem cells, can be collected with a simple and risk-free procedure for the mother and her newborn. Blood collection can be carried out both during physiological birth and in the case of a caesarean section. Immediately after cutting the cord, the portion still connected to the placenta is pricked with the needle of the collection bag so that the cord blood can flow inside it by gravity, up to the maximum amount. Once filled, the bag is placed in the isothermal container and then in a high protection grade carrying case.
The withdrawal does not involve changes to the normal care procedures for the mother and the newborn. Healthcare personnel are not responsible for collection procedures.
Families wishing to preserve cord blood stem cells for preventive measures can apply for the Export Authorization at a foreign private facility from the Health Department of the hospital where the delivery will take place (State-Regions Agreement of 29 April 2010). According to the Agreement, the Health Departments of the birth centers have the task of authorizing the export of umbilical cord blood for autologous use, after verifying the requirements of the requesting parents and the characteristics of the recipient bank.
Bioscience Institute deals with the administrative, logistical and health aspects, assisting its customers in the procedures necessary to obtain the authorization for the export of cord stem cells and in the collection of the blood sample at the facility where the delivery will take place.
Step by Step Preservation Guide
At the Bioscience Institute laboratories, biological cryopreservation in liquid nitrogen vapors have been carried out for more than 20 years. Procedures, technologies, and structures of the Bioscience Institute laboratories guarantee standards of excellence certified by supranational bodies and therefore the possibility of reuse over time.
Brochure Bioscience Cell Bank
How to Enroll for the Cryopreservation Service
To use the cord blood stem cell storage service, simply send us an email at info@bioinst.com requesting the collection kit or fill out the online request form. The Bioscience Institute staff will assist you in administrative procedures and, through its scientific committee, will provide you with all the information on the therapeutic use of stem cells and on the most recent developments in scientific research.
The Collection Kit
The Collection Kit will be sent by courier, complete with the necessary documentation. The Bioscience Institute staff will assist you in administrative procedures and will provide you with all the information on the therapeutic use of stem cells and on the most recent developments in scientific research.
Learn More About the Collection Kit
The Collection Kit consists of the necessary equipment to carry out the collection of umbilical cord blood and the documentation required to request the Export Authorization. It is kept in an isothermal case made of waterproof plastic resin, equipped with a pressurization valve for air transport and internally lined with polyurethane foam, which enables it to be resistant to the following:
• To bumps and perforations (it is rigid)
• To thermal excursions (it is insulated)
• To contamination (double airtight container is required)
• To variations in environmental pressure (it is equipped with a pressure valve)
• To flooding (it is waterproof)
* The Collection Kit must comply with the IATA procedure PI 650 UN 3373 (Circular of the Ministry of Health No. 16 of 20 July 1994 “Recommendations for the transport safety of infectious materials and diagnostic samples”, Circular of the Ministry of Health No. 3 of 8 May 2003) and must also be easily visible/identifiable in compliance with the Ministerial Ordinance of 4 May 2007 and regional regulations.
The case contains the following:
• 1 sterile bag with 2 needles for the collection of cord blood
• 2 disinfectants and 2 sterile gauze compresses
• 1 waterproof isothermal wrap to protect the blood bag
• Documentation to be submitted to the health management to obtain the authorization stickers
• Conservation contract
• Collection instructions
Our Dedicated Logistics Service
On the day of admission, you will have to take the Collection Kit to the hospital and deliver it to the health care staff responsible for the delivery, who have been notified in advance. After the blood collection you will have to activate the ordinary procedure for the collection and shipment of the blood unit by contacting the Bioscience Institute immediately.
The bag will travel at room temperature in a highly protected, double isothermal container and does not require refrigerated vehicles. The shipment of cord blood to the Republic of San Marino will be constantly monitored according to dedicated and specially designed logistics, not requiring customs controls, and allowing flexible management of any problems related to holidays, strikes or adverse climatic situations.
If necessary, a dedicated courier will be activated which will guarantee the delivery of the biological material to the Bioscience Institute within the deadlines established by the Ministry of Health (“Guidelines for the accreditation of umbilical cord blood banks”) regardless of any adverse event.
Cryopreservation Process
Upon arrival of the Collection Kit, the Bioscience Institute staff will perform the procedures necessary for the separation of the stem cells contained in the umbilical cord blood collected and then proceed with freezing and cryopreservation. Upon request, the cell sample can be divided and cryopreserved in two separate units (bags).
The cryopreservation has a minimum duration of 20 years, which will be automatically renewed for all the years for which the annual fee will be paid.
The Step-by-Step Guide to Preservation
Contract and Costs
The conservation contract is provided inside the collection kit. Bioscience Institute, as owner of the laboratories, offers parents a direct contract, without using any brokerage company.
This means that the company:
✓ Is directly responsible for its work, committing itself never to transfer the rights deriving from the contract to third parties
✓ Contractually undertakes to maintain the quality level of the procedures adopted and the structure in which it operates unchanged over time
✓ Stands as the sole interlocutor, as the owner of the laboratories where stem cells are physically stored
Warning!
If the company with which the CONTRACT is signed is free to transfer the rights to third parties, there is a risk of not being adequately protected: the company to which their stem cells have been entrusted could in fact transfer the rights to a company that does not guarantee the same quality standards.
The Costs of the Service
The conservation costs include a contribution to conservation and the payment of an annual fee. To receive the Collection Kit, only the membership costs must be paid in advance, while the payment of the cryopreservation service will be required only after freezing.
Why an Annual Fee?
The Bioscience Institute proposes a contract that provides for the payment of an annual fee because in the biotechnology sector, quality is obtained and maintained over the years only through investments of high economic value. In biological cryopreservation, ensuring a high standard of quality is the only way to preserve cord blood stem cell samples so that they can be used for a transplant. The payment of an annual fee for the maintenance of biological samples represents the safest method to guarantee, year after year, the coverage of the costs generated by their conservation.
Duration of cryopreservation
The contract provides for a minimum duration of cryopreservation of 20 years and can be tacitly extended. On the one hand, the actual potential of stem cell treatments has been known since 1988, the year in which for the first time a child recovered from Fanconi’s anemia, owing to a transplant of hematopoietic stem cells obtained from the blood of his younger sister who had just been born.
On the other hand, a more recent scientific publication has documented the success of an autologous transplant, in humans, of hematopoietic stem cells stored for a period of 21 years. The Bioscience Institute offers the option of extending the contract while you continue to pay the annual fee.
References:
1. The Italian system of hematopoietic stem cell transplants. Alessandro Nanni Costa, National Transplant Center – ADISCO, 2009
2. Holter J et al. Successful autologous stem-cell transplantation after 21 years of cryopreservation. Transplantation. 2011 Apr 15;91(7):e54-5.
3. Broxmeyer HE et al. Hematopoietic stem/progenitor cells, generation of induced pluripotent stem cells, and isolation of endothelial progenitors from 21- to 23.5-year cryopreserved cord blood. Blood. 2011 May 5;117(18):4773-7.
Guarantees Offered by Bioscience Institute
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.
Guarantee: 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.
Guarantee: Quality & GMP Standard
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 about 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 →
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.
Guarantee: Quarantine Procedures
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.
Guarantee: Transport & Storage
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.
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
• 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.
In-depth Information
Would you like to explore further or learn more? Access comprehensive explanations by expanding the sections below.
Embryonic vs Adult Stem Cells
There are two families of stem cells: embryonic and adult. The cells that can be preserved by taking cord tissue are adult stem cells.
Embryonic stem cells
Embryonic stem cells are found in the embryo from conception until the fourth day of gestation. These are totipotent cells, that is, capable of giving rise to all types of specialized cells in the organism. Today there is no scientific evidence regarding the safety of their use and possible clinical uses.
Adult stem cells
The cells that can be stored by taking umbilical cord blood are adult stem cells. Adult stem cells are undifferentiated cells that multiply to replace damaged cells and regenerate tissues. Unlike embryonic stem cells, their use for therapeutic purposes is not controversial because the destruction of an embryo is not required and because their biosafety has been abundantly demonstrated.
What is the difference between allogeneic (heterologous) and autologous storage of umbilical cord blood?
Allogeneic (Heterologous) Preservation from Donations
Donations involve extracting the stem cells from umbilical cord blood and making them available to the community. In this case, after verifying the suitability of the parents, the umbilical cord blood is collected at the time of delivery and the extracted cells are stored in a public bank. When required, they are given to anyone who may need them for a transplant, after verification of compatibility. In 2014, 19,459 units of cord blood were collected for donation, of which only 1,738 were frozen.
Autologous Conservation for Your Child
When stem cells are stored for the newborn, this is referred to as autologous storage. According to Italian legislation, if the newborn is affected by a pathology, he/she has the right to free autologous conservation at a public bank. The Decree of 18 November 2009 lists the diseases that are currently treatable with stem cells from umbilical cord blood. However, if the newborn is healthy and the conservation request is made for preventive purposes, parents should contact private laboratories, such as the Bioscience Institute.
