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Family Bank: Cryosite
Established in 2002, Cryosite was the first family cord blood bank in Australia, and the first to be fully licensed by the Therapeutic Goods Administration (TGA), as well as accredited by NATA. In 2015 we remain totally committed to our goal of developing world class, science based, cord blood and tissue banking solutions. Now, Cryosite is the first to provide validated patented cord tissue storage with a tissue viability guarantee. Listed on the Australian Stock Exchange (CTE), we are the only publicly listed cord blood and tissue bank in the country, with our long term financial position always accessible to parents. Securing your child's cord blood and/or cord tissue is an easy, hassle-free process when you bank with Cryosite.
Labs and Locations
All of Cryosite's stem cell services are fully licensed by the Therapeutic Goods Administration (TGA) - this is important because it guarantees parents regulatory oversight of the Quality and Safety of their children's stem cells into the future.
Cryosite's laboratories and cryopreservation operations are located in new state-of-the-art GMP clean rooms in Sydney, Australia. Cryosite is the ONLY cord blood laboratory in Australia that processes their clients cord blood in clean rooms. Cryosite's facilities have been fully licensed by the TGA (since 2002) and are fully accredited to ISO 15189 and ISO 17025. Cryosite transports and processes cord blood from all parts of Australia and most of SE Asia.
Cryosite's facilities include two GMP-standard clean room laboratories. One laboratory is dedicated to the routine processing and testing of cord blood. The second is a dedicated R&D laboratory that allows Cryosite to partner on a range of stem cell associated projects, including the manufacture of advanced cellular therapy products for clinical trials. Cryosite's facility employs sophisticated IT, environmental monitoring, security and remote alarm systems and is fully supported by automated backup diesel generator power.
Cryosite is an Australian public company and is listed on the ASX (code CTE), thus making their financial position available for public scrutiny. As parents store their children's cord blood for decades, it is important that they have confidence in the long term financial stability of their cord blood bank.
Cryosite commenced operations in 1999, and is the leading private cord blood bank in Australia today. Cryosite was the first private cord blood bank in Australia (2002), the first to be fully licensed by the Therapeutic Goods Administration (TGA) for processing and storing stem cells in their OWN laboratories (2002), and the first to be granted a Family Cord Blood Bank license by the TGA (2011).
Cryosite has developed a robust and well diversified business model. In additional to family cord blood banking services, Cryosite is internationally recognised for the provision of sophisticated cold chain and cryogenic storage services to major global pharmaceutical and biotechnology companies. Cryosite’s services include Adult Stem Cell Banking, Bio-repository management, Clinical Trials logistics and specialised cold chain distribution services.
Cryosite's senior staff have previously worked in the public bio-banking sector, including the Australian Red Cross Blood Transfusion Service and the Australian Public Cord Blood Bank.
Cryosite's Cord Blood Collection Kit is registered as a Class IIb Medical Device by the Australian Therapeutic Goods Administration (TGA). The collection kit contains everything required to collect cord and maternal blood and transport it safely back to Cryosite for processing, testing and long term storage. All items in the kit are individually traceable to a child's cord blood by batch number and expiry date.
Cord blood is collected by gravity feed into a sterile cord blood collection bag. The collection bag can be used in the operating theatre for C-Section deliveries. Each cord blood collection kit includes unique bar-code labels to positively identify your child's cord blood, maternal samples and all associated collection paperwork.
To ensure the temperature remains within range during transport, Cryosite transports cord blood in a validated insulated cord blood shipper with preconditioned gel packs (supplied by our courier). Cryosite's couriers place the preconditioned gel packs into the shipper immediately prior to transport. An automated data-logger is used to monitor the temperature of the cord blood and maternal samples during transport.
After the Cord Blood is collected, parents phone Cryosite's 24/7 call centre and we coordinate the dispatch of a specialist medical courier to pick up your child's cord blood from your hospital or birthing centre. Keep the collection kit with you until our courier arrives. All cord blood collections are transported to our Sydney Laboratories and processing commences within 36 hours of birth. We co-ordinate the necessary air and land transport from anywhere in Australia or SE Asia. Cryosite tracks your cord blood from the point of collection until receipt by the laboratory. Shipping within Australia is included in the price. Cryosite quotes separately for international shipping.
The cord blood is initially separated into coponents by centrifugation and volume reduced using Optipress II methodology. Cryopreservation is performed by mixing the cells with 10% DMSO/Dextran (Cryosite only utilises premixed single use vials of cryo-preservative) and cooling them at a controlled rate of 1-3°C per minute.
All cord blood processing is performed inside positive pressure clean rooms to eliminate the potential for cross contamination. Cryosite is the ONLY cord blood laboratory in Australia that processes their clients cord blood in clean rooms.
Cord Tissue Banking - The Facts!
Cord tissue banking is in its infancy and cord tissue banks are not yet regulated by the TGA. When selecting a cord tissue bank it is essential that you ensure the quality of processing and storage methods used can effectively preserve your baby's stem cells for future approved uses.
There are two different methods currently being provided within Australia:
1. Freezing segments of umbilical cord.
2. Isolation and freezing of the high value perivascular stem cells from the umbilical cord.
As each method has distinct advantages and disadvantages, and cord tissue storage is a very new and emerging area of stem cell science, we store all umbilical cord tissue using BOTH methods. This provides more options for potential treatments in the future.
Cord Blood stem cells are stored in two individual freezing bags in vapour phase cryogenic nitrogen (below -180°C) together with small archive vials to enable mandatory pre-release testing without compromising stem cell Quality. Maternal samples are archived for future testing in -80°C Freezers.
From the umbilical cord tissue all cell types present are stored: Mesenchymal Stem Cells (MSC), Endothelial, & Epithelial cells (ESC).
Cord blood is stored in two individual freezing bags in the vapour phase of cryogenic nitrogen (below minus 180 deg C). Cryosite's storage tanks are remotely alarmed and monitored, and a permanent history of storage temperatures is maintained. Cryosite's comprehensive QA program monitors the long term viability of donated test samples (these are not our client's samples) to ensure there is no loss of viability over the storage period. Once the cord blood stem cells are successfully stored, Cryosite issues parents with a Certificate of Storage.
Licensing & Accreditation
Cryosite is fully licensed by the Therapeutic Goods Administration (TGA) for Family Cord Blood Banking and is the only cord blood laboratory in Australia to be NATA accredited, as well as meeting ISO standards (ISO 15189 and ISO 17025).
Cryosite holds the following regulatory licenses and accreditation:
• Therapeutic Goods Administration (TGA): Licence number MI-18072008-LI-002488-11 (since 2002). In Australia, the TGA is responsible for regulating the manufacture of all therapeutic goods. This includes blood, tissues, cellular therapies and cord blood (HPCs).
• National Association of Testing Authorities (NATA): Accreditation number 14598
• International Standards Organisation (ISO): Cryosite's laboratories are accredited to ISO15189 and ISO17025.
• ASX Listed: (ASX code CTE).
As Cryosite is a publicly listed company, our current and ongoing financial position is also independently audited, is publicly available, and complies with the Corporations Act and Accounting Standards & Corporations Regulations.
Cryosite has successfully released cord blood for clinical use between family members (directed allogeneic treatment) and was the first private cord blood bank in Australia to be granted a Family Cord Blood Banking license. Patient updates, where approved by client, are included on our website. Also, Cryosite has released over 10 adult HPC-A stem cells for the treatment of cancer in adults.
Cryosite's Tissue Viability Guarantee
Cryosite proves the viability of every cord tissue collected by extracting and expanding the valuable Mesenchymal Stem Cells (MSC). We provide parents with peace of mind by providing photographic evidence to demonstrate that their baby’s expanded stem cells are viable prior to storage. Companies that simply freeze the umbilical cord cannot ensure that the cells banked are viable, which means you could be paying for nothing. If your baby’s tissue stem cells are not viable prior to storage we will let you know and refund your tissue fees.
Cryosite's Financial Stability
When storing your child's stem cells for many years into the future, the best guarantee that your cord blood bank will be there when you need them is to take the time to assess their experience and financial stability.
Cryosite is Australia's only publicly listed cord blood bank (ASX code CTE) and is therefore the only cord blood bank to make its financial position available for public scrutiny. Cryosite has developed a diversified and secure business model and has a strong record of profitable operations. Cryosite commenced operations in 1999, and has offered Australian parents the option of private cord blood banking, in our own TGA licensed laboratories, since 2002.
While Cryosite understands that long term cord blood bank stability is a major concern for many parents, please be aware that it is not possible to provide a contractual guarantee regarding the long term storage options or costs associated with transferring cord blood to another provider in the unlikely event that Cryosite was unable to provide storage at some time in the future.
In the circumstance where a family cannot afford to bank their child's cord blood and their child, or another family member, has been diagnosed with a condition for which the treating clinician has determined the cord blood is likely to be used, Cryosite can assist to meet the costs of collecting and processing the cord blood. Please contact us to discuss your needs and eligibility.
Cryosite has an active community education program and provides cord blood education sessions for parents, obstetricians, and midwives.
Link to the table of price options
Cryosite strives to keep the prices for cord blood banking as low as possible without compromising the quality of the service, which is our absolute priority. Cryosite does not require full payment until your child's stem cells are safely stored. Cryosite has payment plans for initial storage periods of either 18 or 25 years. When your child turns 18 or 25, they can extend the storage period by paying a nominal annual storage fee. Full details of our payment plans are included in our Storage Agreement (available on our website www.cryosite.com).
Additional Cryosite Discounts or fees:
• Existing Cryosite clients - $200 discount
• If you have previously banked with someone else - $150 discount
• Twins Discount - $400 discount
• Refer a friend bonus - $50 Gift card
• Late Registrations – An additional charge may apply if a collection kit needs to be sent using a "same day" courier.
• Collection Fees - There is no collection fee if your doctor or midwife performs the cord blood and maternal collection for you. A collection fee may apply if you require Cryosite to provide you with a collector.
A note on comparing costs:
The viability of banked cord blood stem cells and its availability for future use, depends on the experience of the scientists, and the long term security of company you chose to bank with. Parents have a choice between several private banks and when deciding, the experience and security of the cord blood company, as well as the cost, is an important consideration.
In addition to private cord blood banking Cryosite also provides the following additional services:
• Adult Stem Cell Banking
• Adipose derived MSC banking
• GMP banking for Master and Working Banks
• Clinical Trials Logistics services
• Bio-repository management services
Cryosite has partnered with regenerative medicine company, Regeneus, to jointly develop a protocol for the cryopreservation of human regenerative stem cells. A first within Australia, these regenerative cells can be stored as a patient's own "biobank" for future treatments of their musculoskeletal conditions such as osteoarthritis. The process involves harvesting a small amount of a patient's own adipose (fat) tissue, extracting the regenerative cells and re-injecting the cell preparation in osteoarthritic-affected joints such as knees, hips and ankles. These extracted regenerative cells include mesenchymal stem cells and adipocytes, which work together to reduce inflammation and also promote regeneration and repair of tissue.