faq

Who will perform the collection procedure?

The mobilisation of the stem cells by the injection of growth factors and the collection of the stem cells will take place at either the Peter MacCallum Cancer Centre or the Cabrini Hospital in Melbourne. You will be under the care of a haematologist and qualified apheresis nurse who will operate the blood cell separator and will monitor you and your medical status at all times. Prior to collection you will be required to consent to this procedure and to certain tests which are mandated by the Government regulator (TGA), for the presence of infectious diseases agents including HIV, Hepatitis C and Hepatitis B.

What happens to my cells after collection?

Following collection, the blood is taken to the stem cell processing laboratory at the Peter Mac. In the laboratory, procedures to ensure the quality of the product take place, including counting the number of stem cells, and testing for sterility. The next stage is to process the product and freeze (cryopreserve) it. This involves the adjustment of the cells and the solutions in which they are suspended by the addition of a chemical which minimizes damage to cells during freezing. After this step, the cells are frozen in a computer-controlled freezing chamber. They are now ready for cryogenic storage until they are required for infusion (weeks to years later).

TGA auditors rigorously audit all of the processing steps and the reagents and equipment used in the procedure. The Peter Mac has been issued with the appropriate manufacturing license for this procedure (License 149827).

How are they stored?

Until they are required for infusion, stem cell products are stored in the vapor phase of liquid nitrogen. This method is regarded as the optimal storage technique for the maintenance of cell and tissue viability

Where are they stored?

Short-Term Storage at Peter Mac

The Peter Mac has the facilities in Melbourne to store stem cell products for a “Short-Term Storage Period” prior to the transfer of those products to Cryosite for Long-Term Storage. The following conditions will apply to the storage of stem cell products at the Peter Mac Facility.

In the event that your cells may be required in the short term, the Peter Mac will hold your cells after processing and freezing for up to 60 days.
The Peter Mac does not charge for the short-term storage of stem cells at its facility.
If your stored stem cells are required for treatment within 60 days, either at the Peter Mac or at another facility, your doctor will provide written directions, including the name and address of the medical practitioner or hospital to receive the stem cells. After an authorised, written request has been received, shipping of the cells will be arranged. In this case, your cells will not be shipped to Cryosite.
The Peter Mac will automatically transfer your cells to Cryosite for Long-Term Storage after 60 days.

Long-Term Storage at Cryosite

The Peter Mac has an agreement with Cryosite for the long-term storage of stem cell products. For Cryosite to store your product, you will be required to sign both a “Consent and Acknowledgment” and a “Storage Agreement”. Once you have signed these agreements, Cryosite will arrange for your stem cell product to be collected from the Peter Mac and transported to its long-term storage facility in Sydney. Under the terms of your agreement with Cryosite, and the Peter Mac’s separate agreement with Cryosite, Cryosite is responsible for ensuring that stem cell products are properly transported, stored, retrieved and when requested transported back to the relevant hospital/medical practitioner for transfusion or transplantation.

Who is Cryosite?

Cryosite is a publicly-listed Australian company, established in 2000 to provide specialist ultra-low temperature and cryogenic storage services to a wide range of clients including the research, medical, pharmaceutical and biotechnology industries.

Operations are carried out in a NATA accredited (ISO/IEC 17025) facility, and in compliance with the code of Good Manufacturing Practice for Human Blood and Tissues.

The company operates a Quality Management System that ensures compliance with all necessary regulations. All Cryosite staff involved in the handling of your stem cells have the appropriate qualifications and experience and understand the high level of care that is required to provide this service.

Is Cryosite Licenced to Store my Cells?

All facilities that are involved in the manufacture of any blood product must comply with the Federal code of Good Manufacturing Practice for Human Blood and Tissues. The Therapeutic Goods Administration (TGA) administers this code and conducts regular audits to ensure compliance. This includes both the Peter Mac where your collected stem cells are processed and cryopreserved and Cryosite which provides long-term storage.

Security is a critical consideration when storing valuable samples for an extended period of time. To ensure security of your samples Cryosite has implemented a Quality Management System that includes the following precautions:

The facility is secured with strictly controlled smart card access entry, and back-to-base intrusion alarms. An audit trail tracks access to the facility and storage units
Storage units are individually secured and monitored 24hrs a day with alarms directed to a 24 x 7 manned alert facility. Cryosite staff are on-call to respond to any alarm events.
The facility has climate control to minimise temperature fluctuations
A diesel generator supplies backup power
Backup power bypasses the main switchboard to the building. The facility has an independent switchboard and UPS power supply
Liquid nitrogen storage units are automatically refilled using a level monitoring system.
Supplier guaranteed 24 hour x 7 day emergency deliveries of liquid nitrogen

How are they transported to Sydney?

The samples are placed into a special cryogenic shipper, designed for the safe transportation of biological samples at cryogenic temperatures. The shipper has a protective shipping carton that protects the container from damage during transportation. The shippers have been tested and approved to meet current UN and IATA shipping regulations.

How much does it cost to store my cells?

You will usually have at least two bags, and in most cases patients will have four to six bags of frozen stem cells. The maximum price you will pay is for the storage of 10 bags of cells. If you need more than 10 bags of cells stored the price will not increase any further. The price schedule is set out in more detail in the Cryosite Storage Agreement.

You must also allow for a shipping fee for transferring the cells from the Peter Mac to Cryosite and if you retrieve cells there is a recall request fee plus the shipping fee. The price schedule is set out in more detail in the Cryosite Storage Agreement.

Cryosite will invoice you directly for the costs; no payments will be handled by the Peter Mac for storage or shipping of cells. Payment must be made either by bank direct debit or by credit card debit authorization.

Who will remind me about payments for ongoing storage?

Cryosite will contact you before the annual renewal is due for the next year of storage. If mail is returned, or no payment is made, after 60 days Cryosite may at its discretion dispose of your cells. Cells will be destroyed by incineration, as medical waste according to industry standards. However, before disposal can occur Cryosite is obliged to advise the Peter Mac of its intention so that your haematologist can be informed. Therefore, it is important that you advise Cryosite of any change of address, billing arrangements or other contact details.

Change of Address

So that Cryosite can contact you, you must notify Cryosite in writing as soon as you change your contact details.

If I need them, what is the process to recall my cells?

In the event that you need to recall your stored stem cells for treatment, your doctor will inform the Manager of the Peter Mac who will instruct Cryosite to make the cells available for release.

If I need them, how long will it take to recall my cells?

Once the recall procedures have been completed, Cryosite will ship the cells immediately or as otherwise agreed.

Who has access to my cells?

Your stored stem cells are being stored for your use only. Under no circumstances may your cells be sold or passed on to another individual or organisation. The blood stem cells are the property of you, the client. Cryosite has no property in or ownership of the cells.

What happens if I no longer want to store my cells?

You may at any time give Cryosite 90 day’s written notice that you wish to terminate the storage. On termination of the storage agreement, Cryosite will dispose of the stem cells. Cells will be destroyed by incineration, as medical waste according to industry standards. However, before disposal Cryosite is obliged to contact the Peter Mac so that your haematologist can be informed of your request.

What happens to my cells if I die?

Upon written notification by a legally responsible person or authority, Cryosite will dispose of the stem cells. Cells will be destroyed by incineration, as medical waste according to industry standards.

I am in remission - why should I continue to store these cells?

You are only likely to need your stems cells if you subsequently undergo high dose chemoradiotherapy for treatment of your disease. Thus, if you remain in remission you may never need your cells. You should discuss with your doctor whether it is advisable to continue to store your cells.

How long will the cells last?

It has been demonstrated that cells may have been stored for 3 years with acceptable viability and there have been reports of patients having been successfully transplanted with cells stored for more than ten years. If cells that have been stored for more than 3 years are to be used, your doctor may request tests confirming the viability of the cells before recommending their use.

Can I give my cells to someone else?

No. Your cells are for your use only and cannot be used by anyone else. If you do not want to continue to store them, they must be destroyed.