AboutSmartBank S.r.l. was the first Italian company to offer cord blood storage, and one of very few companies serving this market that is based in Italy. SmartBank contracts to the BioVault laboratory, the only facility in the UK which is licensed to provide both private storage and public donations for the UK National Health Service.
Labs and LocationsSmartbank entrusts its client samples to BioVault, the largest private human tissue processing and storage bank in the UK. Located in Plymouth, on the medical campus of Derriford Hospital, Europe's 4th largest teaching hospital, BioVault is the processing facility for the UK South West Peninsula Transplant Programme (which is the NHS). Blood testing of virology and microbiology is performed nearby at Derriford Hospital, which is CPA accredited.
Plymouth International Medical and Technology Park
24 Brest Road,
Derriford, Plymouth, PL6 5XP,
Business ExperienceSmartbank has marketed cord blood banking since 2005. The founder and Scientific Director of SmartBank is Dr. Irene Martini, a cellular biologist with many years of research experience, and a member of a number of leading independent advisory boards dealing with issues of stem cells storage and therapies. Dr. Martini has worked on EU and WHO research projects, writes for a number of scientific journals, and is a regular speaker at international stem cell conferences.
Collection KitThe collection kit uses a Macopharma bag, a system based on double venepuncture of the umbilical cord, Chlorhexidine disinfectant, and the ideal quantity CPD anti-coagulant to ensure a simple and a highly secure cord blood collection. The Macopharma bag offers excellent recovery of stem cells, thanks to needles specifically sized for umbilical veins to allow maximal flow, and to a specially designed bag for rinsing the collection line tubing and the maximal safety of use, providing fully equipped systems:
- Secure needle caps
- Double sterile overwrap
- Inner protective overwrap for a clean pack in the delivery room and sterility in operating room.
Transportation ContainerThe transportation container conforms to the provisions of EC DIRECTIVE 93/42/EEC amended by 2007/47/EC and to packaging instruction 650 of IATA Regulations. The container has advanced insulation properties because of the gel packs and the innovative vacuum insulated panels that provide the optimum temperature protection to the blood. This means significantly less temperature fluctuations and blood cycling, crucial for the quality of the sample. The container is guaranteed to maintain temperature for 72 hours.
Shipping Info:The contract price includes shipping and the arrangements are made by SmartBank, using different shippers - DHL Express, Airplus Express, or TNT- each of them operating in compliance with IATA Regulations. Depending on circumstances, Smartbank chooses the courier best placed to guarantee the fastest delivery. For shipping from outside Italy, clients would incur extra costs.
Processing MethodThe sample arrives in the laboratory and is processed on the same day. SmartBank Laboratory processes are manual and based on the volume reduction methods described by world renowned stem cell scientist Dr. Rubenstein, methods currently quoted as achieving a stem cell recovery rate of >95%. The sample enters the BL3 clean room through a hermetic window with positive exit flow. Inside BL3, the sample is weighed, centrifuged, measured volumetrically, and undergoes microbiological tests, HLA tests, cytofluorimetric reading and any other tests required. The sample containing the cells is placed in the final PALL container or cryobag, and is mixed to 10% with DMSO. The cryobag is placed in a computerised temperature-reducing system. After the temperature has decreased, the cryobag is placed in a sealed metal container while small blood samples are separated for laboratory tests. The laboratory data is printed on the certificate of cryogenic storage signed by the SmartBank Scientific Director and duly authorized by the Laboratory Director.
Components StoredEmocomponents are removed from the blood because they could damage the quality of stem cell. Stem cells are then analyzed. Parents are provided with a certificate describing test results: viability and the number of CD34+ stem cells are tested for each sample as well as total number of leukocytes.
If the cord blood contains an insufficient amount of stem cells (less 500,000 cells) and/or of insufficient viability (at least 60% of metabolically active cells) or a combination of the two parameters, SmartBank guarantees parents the right to withdraw from the cryogenic storage contract and will partially reimburse parents (reimbursement fee is 1,500 Euro). In the event of withdrawal, the sample will be destroyed and the decision is therefore irrevocable.
It is also appropriate to point out that cord blood, in addition to CD34+ stem cells, traditionally used to cure haematological pathologies, also contains other stem cells known as “CD133+ and mesenchymal cells” which, if differentiated, provide a series of cell types such as:
- nerve cells (useful for Ictus, Amyotrophic Lateral Sclerosis, Parkinson’s Disease, spine bone marrow damage and cerebral paralysis),
- cardiomyocytes (useful for cardiovascular pathologies),
- muscle cells,
- osteoblasts (useful for bone reconstitution, cartilage reconstitution, repair of ligaments),
- pancreatic cells (useful for Type I Diabetes),
- myelinic cells,
- hepatocytes (for liver damage),
- endothelial cells (for ischaemic pathologies)
- and epithelial cells (for cornea, retina transplants, emphysema of the lungs, cystic fibrosis, and epithelial reconstitution).
Storage MethodThe final storage is in PALL bags that are placed inside canisters. Specifically-separated subsamples are stored for any future tests required in case of transplant and/or treatment. In final storage, The stem cells are kept in the vapour phase of cryogenic nitrogen at -196°C. The temperature is controlled 24 hours a day, 7 days a week by staff and by automated systems.
Licensing & AccreditationThe BioVault laboratory...
- holds an open ended, unconditional HTA licence (no: 11063) which covers every aspect of all transplantable material for human application.
- operates in accordance with GMP procedures (international Good Manufacturing Practice protocol) drawn up by the W.H.O (World Health Organisation);
- is certified as Grade A, in a BL3 clean room (an environment that eliminates the introduction, generation and keeping of aero-transported particles, comprising 3 concentric areas with positive atmospheric exit pressure)
- is authorized to treat samples affected by some bacterial infections that can be cured by treatment, in quarantine
- has been accredited by the American National Standards Institute Regulatory Accrediting Body
- has been accredited by the Advancing Transfusion and Cellular Therapies Worldwide
- is currently being accredited by JACIE.
- its organization's internal Quality Management is ISO 9001:2008 certified, (certificate no: GB04/62552)
- its Quality management standards for medical devices is ISO 13485 certified (certificate no: GB07/72849)
- its flow Cytometers are externally quality controlled by NEQAS.
Clinical ExperienceThe BioVault laboratory has stored over 20,000 cord blood collections as of Sept. 2011. BioVault has 7 cord blood transplants on behalf of private clients, 3 of them for autologous use (by the baby who banked). BioVault has additional clinical experience preparing stem cells for transplant by the NHS, for whom they have released over 2,500 bone marrow and peripheral blood stem cell transplants, all with a 100% success record.
SmartBank of Italy participates in the clinical trial CORDHA in partnership with Hospital S. Giovanni Calibita Fatebenefratelli in Rome. The goal of the trial is to show that DHA, in pregnancy, results in an increase in mature tissue and the number of stem cells extracted from umbilical cord blood. DHA (docosahexaenoic acid) is an essential fatty acid line Omega 3, usually prescribed to pregnant women as an adjunct to diet for its beneficial effects on mother and neurocognitive development, psychomotor activity and sight of the foetus. This potential positive effect on stem cells numbers, is particularly important for the preservation of stem cells, since restrictions on the use of cord blood for therapeutic purposes is related to the number of cells. Generally the amounts collected from the umbilical cord are sufficient for transplantation in a child of 14 years, while an adult may need to use combined samples from donors or to expand the matching stem cells in the laboratory.
InsuranceFor the entire duration of the contract, parents have the right to request the use of the Sample for therapeutic purposes. The contract service includes retrieval of the cells and any tests or treatments requested when the sample is removed, as well as delivery to the chosen accredited transplant centre.
Smartbank gives parents the opportunity to choose for an additional service, “supportive family storage”. In this option, the sample is privately stored and after HLA typing, it is registered in the international register of samples that can be donated. Therefore, whenever the sample is compatible with a transplant request, it is donated and SmartBank reimburses the cost of cryogenic storage.
When no transplant requests are made, the sample remains available for the person depositing it according to the family storage formula. The possibility that the sample is donated makes thorough checks on the mother’s health and informed consent for donation essential. The family is always free to decide
whether to donate or not.
BioVault has Professional Indemnity insurance in place with Lloyds of London for 10,000,000 pound Sterling for any single event.
Community ServiceSmartbank offers discounts in the following cases:
- 50 Euro for orders received within 30th week of pregnancy
- 100 Euro for a second, or more, children within the same family
- 100 Euro to medical doctors
- 40% off on the 2nd or 3rd baby in case of twin or multiple birth.
PricesTotal initial cost is 2,250 Euro and includes:
- shipping of kit to parents
- assistance and consultation
- delivery of sample from the Hospital/Clinic to the Laboratory
- storage fee for 25 years.
Payment plans are available upon request for 4, 6, 8,12,18, 24, 36 months.
- Smartbank offers maternal blood tests (Syphilis, HTLV1/2 antibodies, Cytomegalovirus) required from EU Directives for therapeutic use of cord blood stem cells: clients can require this service jointly with cord blood for 50,00 Euro.
- Besides cord blood, Smartbank also offers test for lactose intolerance and for celiac disease for babies and their families: price is 110 Euro for both tests or 60 Euro each.
- From 2012, there will also be available storage of stem cells from blood in the placenta and from adipose tissue.