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Swiss Stem Cell Bank - Italy
AboutParent bank: Swiss Stem Cells Biotech
Swiss Stem Cells Bank (SSCB) is the first Swiss structure to offer a private banking service for stem cells, serving many client families in Italy. SSCB was the fifth private bank to achieve FACT-NetCord accreditation, placing SSCB among fewer than 50 of the best cord blood banks in the world. SSCB offers a complete service, with the utmost care and professionalism at every stage.
The SSCB is the first private Swiss structure created with the aim of preserving stem cells from umbilical cord blood. SSCB began operations in 2005 thanks to the contribution of people actively involved in medicine and scientific research. The SSCB objective is to set up a global competence centre supported and developed in synergy with prominent figures in the domain of stem cells. SSCB aspires to be the hub of an international network offering 360-degree consulting in areas ranging from research and sharing of know-how to the therapeutic use of stem cells, and to become a world-renowned centre for consultations on services available and ongoing clinical trials. We aim to give parents the opportunity to store a precious asset for their children - one whose extraordinary potential has not yet been fully realized. Today's children will be able to bank on that capital in the future - even in their adulthood - for the therapeutic applications that medicine and research will develop in the future.
• SSCB is the first Swiss structure to offer a private banking service for stem cells, since the second half of 2005.
• SSCB has been until recently the only cord blood bank to handle laboratory activities entirely and exclusively on the Swiss territory.
• At the end of 2012, after a lengthy and complex certification process, SSCB achieved FACT-NetCord accreditation. This places SSCB among fewer than 50 of the best cord blood banks in the world, and only the fifth private bank to achieve this status.
• SSCB has collected about 20,000 cord blood samples from around Europe, mostly Italy.
• SSCB offers a complete service, with the utmost care and professionalism at every stage.
• Either directly through our dedicated call centre, by telephone or by Email, SSCB aims to give the customers an exhaustive information about stem cells, their therapeutic utilization and the different options for umbilical cord blood stem cells conservation.
The kit used by SSCB to take and transport the umbilical cord blood is made by the company INNOPLUS Srl on the basis of infectious substances shipping guidelines from International Air Transport Association (IATA) as well as accordance with any applicable European standards.
The main kit component parts are:
1) Sampling bag, made and certified by TERUMO PENPOL, India. The Terumo Penpol bag offers excellent recovery of stem cells, thanks to needles specifically sized for umbilical veins to allow maximal flow, and for the maximal safety of use, thanks to needle caps and extra sterile overwraps.
2) The blood bag is pre-loaded with the ideal anticoagulant CPD.
3) Sealed sterile wrap, made and certified by DGP INTELSIUS Ltd, UK. The SSCB collection kit may be used in a sterile operating room.
4) Bag containing 2 test tubes, made and certified by EXTRA PACKAGING CORPORATION, USA.
5) Third wrap, polystyrene foam thermal container, made and certified by INNOPLUS Srl, Italia.
The blood sample must be transported correctly in its transportation kit supplied by the SSCB. The transportation kit follows the IATA PI 650 procedure, which is the international standard for sending and transporting diagnostic samples and the specific EC DIRECTIVE 93/42/EEC amended by 2007/47/EC.
SSCB collection kit includes a thermometer datalogger. The SSCB kit has been validated to maintain a suitable temperature to ensure the viability of the stem cells apart from any external temperature for a duration of 72 hours.
• After the collection of the blood sample (normally done by the obstetrician present in the delivery room), the SSCB operators arrange the retrieval of the sample directly from the place of birth.
• The blood is transported to SSCB laboratory in Taverne by a reliable courier who guarantees delivery to the laboratory within the time limit for the processing phase.
• The retrieval of the blood sample occurs within 48 hours following the birth to ensure the necessary treatment.
• The courier also secures shipping during holidays or weekends.
• Shipping is included in the base price within the home country, costs extra from outside.
• Once at the laboratory, the blood is immediately processed.
• SSCB processing method uses the automated Sepax system developed by the Swiss company Biosafe.
• Sepax is an automated cell separation system that allows volume reduction by depleting red cells and plasma, assuring the higher stem cells recovery possible.
• The Sepax kit is sterile, functionally closed, and single-use; cord blood never comes in contact with the outside environment.
• At the SSCB laboratory the cord blood enters the D class room through a hermetic window. Here the sample is weighed and some aliquots are taken for future tests (such as genetic analysis).
• After that it is centrifuged, measured volumetrically, and undergoes microbiological and serological tests, hemocytometric and cytofluorimetric reading and any other control quality tests required.
• The bag containing stem cells is placed in the final cryobag, and is mixed to 10% of DMSO (cryoprotectant agent) and dextran (for cell nutriment).
• The cryobag is placed in a protective overwrap bag and in a specific canister and then enters a computerised temperature-reducing system.
• After the temperature has decreased, the cryobag is placed in a sealed metal container in cryogenic nitrogen vapour phase.
• The laboratory data are printed on the certificate of cryogenic storage after duly authorized by the Quality Manager supervisor, the Laboratory Director and the Medical Director.
SSCB separates blood into its components and the white blood cell layer, that contains stem cells, is isolated for storage. In addition to CD34+ stem cells, traditionally used to cure hematological pathologies, this bag also contains other stem cells, for example mesenchymal stem cells (MSC) which have big potential in regenerative medicine.
As requested by international law SSCB stores:
• aliquots of whole cord blood
• aliquots of cord blood plasma
• aliquots of whole peripheral maternal blood
• aliquots of maternal plasma and serum
Once testing for microbial contamination is completed, SSCB sends to the parents a certification to attest the fulfillment of the sample storage, identified with a univocal identification code. The document contains the number of separated and stored cells and also the result of the analysis performed on the sample (such as cells viability, serological and microbiological test).
Stem cells, sealed in specially provided cryo-bags and identified with an individual bar code, are progressively cooled at a controlled rate until the temperature of -100 degrees C. In order to control this delicate processing phase, temperature is progressively taken down by a computer ensuring a safe and trustworthy procedure. At this point the bag is placed in vapor phase of cryogenic nitrogen during the quarantine period. Once the quality controls have demonstrated the sample is of good quality, it is transferred to liquid nitrogen at the constant temperature of -196 degrees C. Technologies and rigid operative protocols ensure the utmost security conditions, both during the sample preparation, in the freezing phase and in the following years of storage.
Licensing & Accreditation
SSCB is licensed and continuously inspected by Swissmedic, Swiss Agency for Therapeutic Products -- the Swiss federal authority which supervises quality and safety within the medical field.
Since the beginning of its activity, SSCB has been inspected 4 times by Swissmedic. The latest inspection was carried out on 22.01.2014. It covered both laboratory procedures for cord blood samples and, for the first time, also the laboratory procedures concerning the separation, characterization and storage of mesenchymal stem cells (MSC) derived from adipose tissue. The full report of all the inspections is available here.
Swiss Stem Cell Bank has recently been awarded the prestigious FACT-NetCord accreditation, the worldwide benchmark for umbilical cord banks, both public and private. The organization supervises the activity of cord blood stem cellsbanks to the minutest detail: from the stem cell collection process to the separation of stem cells, and from cryostorage to clinical therapy. SSCB is the first FACT-NetCord accredited umbilical cord bank in Switzerland and the fifth private in the world.
SSCB has partnerships with Cardiocentro Ticino in several research projects on stem cells. The Cardiocentro Ticino has a clean room accredited by Swissmedic that is used for the research. One clinical trial is to treat patients with Myocardial Infarction. This is a multi-center project involving different Swiss hospitals: the patient enters the operating room and undergoes a procedure to take a bone marrow sample. The sample is processed inside the clean room of Cardiocentro Ticino and stem cells thus obtained are sent to origin hospital, where they will be re-injected into the patient's heart. This is all done within 24 hours. Over one hundred patients have already participated in the clinical trial.
The new SSCB laboratory facility in Taverne will increase their scientific collaboration with Cardiocentro research unit but, furthermore, with other research institutes.
• SSCB guarantees the utmost clarity: the price shown at the moment of agreement covers everything including the entire storage period.
• SSCB makes for each sample a provision in order to cover future cost and to assure the 20 years storage. SSCB has set aside capital, since the beginning of the business, so that in case SSCB will be no longer able to ensure the cryo conservation, another company will take care of the samples without asking more of the customers and fulfilling itself on the capital set aside.
• Storage fees paid in advance are held in an escrow account.
• If, for any reason unrelated to SSCB, it was not possible to store stem cells, the amount the clients have paid to SSCB will be refunded, minus any expenses incurred up until that moment.
The price of the service provided by SSCB is different depending from where the birth takes place. The costs for a delivery in Switzerland is CHF 2’800 + 8% VAT: CHF 3’024
The sum includes:
• Informative support managed by a dedicated call center
• Collection kit package delivery and umbilical cord blood transportation
• Transportation of the collection kit from the hospital where delivery takes place to SSCB laboratory in Taverne.
• Microbiological analysis on blood sample
• Sample processing in order to obtain stem cells separation and isolation
• Certification sent to client to attest processing, analysis and storage
• 20 years stem cells cryopreservation
• Possible stem cells retrieval
The price does not include the delivery of stem cells, should they ever be retrieved, to the place where the transplant will occur. Should the client ask SSCB to take care of the delivery of the sample retrieved from the bank, transport expenses will be invoiced to the client.
Other costs: There are no other additional costs, no annual fee, no burden or further charge to be paid by customer in case, during the 20 years, you would ever decide to retrieve the sample to be used for a particular treatment. SSCB will place them immediately at the legitimate owner’s disposal, with no added costs. The transportation expenses from the bank to the hospital where they may be needed, which may be in another continent, will be paid for by the client.
The service may be paid in the following ways:
1. A Payment of the entire amount (CHF 3’024) at the moment of subscription. This solution means a discount of CHF 100. Total to pay CHF 2’924.
2. A down payment (CHF 1’000) at the moment of subscription; payment of the balance amount (CHF 2’024) within 30 days of receiving the invoice.
3. A down payment (CHF 1’000) at the moment of subscription; payment by instalments of the final balance with a supplement of CHF 70 for admi¬nistrative costs. The instalment plan consists of a maximum of 6 monthly instalments of CHF 337.34 each, to be paid in the 6 months following the date of receiving the invoi¬ce. The supplement of CHF 70 must be paid along with the first instalment, which will thus amount to CHF 407.34.
For further details, please visit the website www.stembank.ch
SSCB offers optional newborn genetic testing: these tests are carried out on samples of cord blood and are designed to identify the susceptibility of the newborn to genetic disorders, for example:
Beta (β) thalassemia
Factor V Leiden
.... and many others
Swiss Stem Cell Bank offers patients consulting on clinical trials that employ the stem cells from umbilical cord blood. Being part of a clinical trial is not easy due their variety so it is important to have the knowledge and skills to choose the best clinical trial suitable for the patient. SSCB has that kind of expertises and it is willing to share them with whomever may need help in this field.