CRYO-SAVE LABS

FAQs


Have the stem cells stored at Cryo-Save already been used ? Can you provide me with more information about these cases?

Yes, they have. You will find the medical condition for each here.

How many times can the stored sample be used?

Usually the total sample contains enough cells for one treatment only but this will depend on the indictation for use and the weight of the patient. This will change if hematopoietic stem cell expansion becomes routine practise.

How much time does it take to retrieve a sample from the lab?

Normally it takes a minimum of two weeks after confirmation that the release request is genuine and permission from the family has been obtained.

How safe is your storage site?

Long term storage (or banking) of tissues, cells and the associated data is the core competence of Cryo-Save. The storage sites differ slightly between labs but all of them store samples in two separate tanks in secure rooms with controlled access. All electronic data is backed up off site by specialist third party providers. The environments are geologically stable and the samples are monitored 24/7 for storage temperature, fire and break-in with direct alarm relay. There is a system of early warnings to identify problems before the quality of the cells is impacted that is frequently reviewed as part of a risk assessment programme.

May I visit your laboratories?

Yes, visitors are welcome to visit any of our labs but it is always advisable to contact the respective lab and make an appointment first. Niel has hosted many groups of Drs and VIPs as well as journalists, film crews, students and interested potential clients.

What analysis do you perform?

Cord blood: MNC count before and after processing to calculate recovery; total TNC count and viability with differentials post processing , CD34+ count and viability post processing; microbiology cultures for aerobic and anaerobic bacteria, yeasts and molds; PCR NAT tests for HIV 1 and 2, hepatitis B, hepatitis C, CMV; serology tests for syphilis (Lues). Maternal serology for HIV, hepatitis B and C and syphilis where indicated.

What are the coming applications (in 5-10 years ?)

The most promising fields are neurological applications (like cerebral palsy, traumatic brain injury, stroke, spinal cord injury), heart diseases, peripheral artery disease, auto-immune disoders, liver diseases, orthopaedic applications, burns & wounds, diabetes mellitus and others.

What are the conditions to retrieve my sample?

Samples always remain the property of the donor (or the childs legal guardian until the age of majority, in most cases, the parents). Samples can only be released to appropriately licensed transplant physicians or facilities for further processing and then only with the permission of the owner of the sample. Cryo-Save will ensure that all the appropriate steps are taken once a sample has been requested. In the case of cord blood, tests are completed before release and the results are sent to the transplant team for assessment before the samples is shipped. Cord blood is shipped frozen for thawing at the bed side just prior to transfusion. Cord tissue has not yet been released and will be further processed before it can be used.

What happens when cells cannot be cryopreserved?

Samples not meeting storage criteria are destroyed.

What is FAGG and HTA?

Cells and Tissues for human use and scientific research are regulated under EU law according to the EC Directives 2004/23 EC, 2006/17 EC, 2006/86 EC. EU member states frequently require a license for activities related to stem cell storage and other countries are rapidly following suit. FAGG stands for Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten and is the national government agency responsible for licensing and monitoring tissue banking activities in Belgium. Cryo-Save Labs holds a license for the processing and storage of stem cells from cord blood, cord tissue and adipose tissue. The HTA or the Human Tissue Authority is the UK equivalent and Cryo-Save is licensed for our UK activities. Cryo-Save in other countries e.g. Switzerland, Slovenia and Bulgaria also hold licenses for their respective activities.

What is GMP, AABB and ISO?

These are all accreditations that are not obligatory but are issued by independent organisations who set standards relevent to the industry. GMP stands for Good Manufacturing Practice. AABB, the American Association of Blood Banks, issues standards relevent to blood banking activities in general including cord blood banking. ISO is the international organisation for Standardisation of which ISO 9001 is a well known standard for Quality Management.

What is the advised and the effective maximal transport duration?

Ideally samples should be processed as soon as possible after collection. FACT (Foundation for the Accreditation of Cellular Therapies) requires autologous blood stem cells to be processed within 72 hrs. Internal validation has shown that 3 days in transit is also applicable to cord tissue.

What kind of backup do you have?

There is back-up for every element of the Cryo-Save process to ensure that all samples are processed and stored without delay or mishap. Personnel, equipment, supplies, storage capacity, electronic data, monitoring systems and security are all backed up to ensure continuity of service.

What processing method do you use?

Cord blood is stored as a buffy coat concentrate by removing most of the plasma and red cell fractions. This is carried out using the Sepax closed system method. Cryo-Save uses the automated Sepax system from the Swiss company Biosafe.

When is stem cell storage considered successful?

For all our products - cord blood, cord tissue and adipose tissue preparations, storage is considered successful when all acceptance and storage criteria are met. Several factors are considered including collection, transport, infectious status, tissue volume and cell counts.

Where is my sample going to be stored?

All samples are divided into two parts and are stored in separate tanks at the lab where the sample was processed. Indian samples are stored in the Bangalore lab, German samples are stored in Mannheim, Samples from UAE are stored in the Dubai lab and samples from the rest of the world are stored in the main lab and storage facility in Niel, Belgium.

Who has access to the lab?

Access is limited to authorised personnel only for reasons of safety and security of both samples and personnel.

Why can the sample only be used once if the storage is in two separate locations?

Because of the stem cell quantity. The two separate locations really is for safety purposes and for anticipating the medical advances in stem cell expansion.

 

More FAQs can be found by visiting our customer website at: www.cryo-save.com