Cryo-Save South Africa
AboutCryo-Save is the largest family cord blood bank in Africa and Europe. Cryo-Save has more than 280,000 samples stored and six storage facilities across the globe. Cryo-Save has over 14 years experience and state-of-the-art technical know-how, providing the basis for a strong and reliable organization. An ethical approach, scientific professionalism and customer-focused care are the core elements of their daily activities, as they strive to be an active player in life-science development. Cryo-Save has cryopreserved samples from over 70 countries on six continents, is present in more than 30 countries and cooperates with 6 000 hospitals worldwide.
Labs and LocationsCryo-Save has been present in South Africa since 2002, with the opening of their current state-of-the-art laboratory in January 2013, located in Pretoria.
The full address of the Cryo-Save office in South Africa:
Ground Floor, Acacia House,
Green Hill Village Office Park,
Corner Botterklapper & Nentabos Street,
The Willows, 0041 Pretoria, South Africa
Business ExperienceCryo-Save South Africa was launched 13 Sept. 2011 as the result of the joint venture between Cryo-Save Group (Esperite N.V), the leading international family stem cell bank, and JSE listed Escalator Capital (formerly banking cord blood as Lazaron Biotechnologies). The new joint venture company offers clients in Southern Africa unmatched financial security and corporate governance. Clients can choose between local storage in the Pretoria lab or international storage at the Cryo-Save headquarters in Niel, Belgium.
Collection KitThis world class Collection Kit is designed and manufactured in Europe according to the strict standards of the European Union and conforms with the EU-applicable Medical Devices Directive 93/42/EEC. Article 12, as amended by 2007/47/EC.
Each Collection Kit uses high tech NeoPor packaging which has superior insulation qualities and temperature stabilizing cool packs that will ensure optimal transport conditions are maintained regardless of the climatic conditions. This is the best way to safely transport your baby's blood to ensure maximum cell viability is maintained. All materials in the collection kit are sterile both inside & outside so that they can be used in an operating room during a C-Section.
Before the delivery of the baby, the Cryo-Save customer receives a collection kit enabling physicians or midwives to collect the umbilical cord blood & tissue. Cryo-Save provides them with adequate information and training beforehand as appropriate.
- • Cryo-Save's container conforms to Art. 12 of the MDD and is EU approved.
- • Cryo-Save's container has activated cool packs AND thermal insulation in the transport box.
- • Cryo-Save's container is validated to maintain temperature within set criteria under test conditions.
- • Cryo-Save's container is guaranteed to maintain temperature for a certain number of hours, to permit a safe arrival at the lab.
- • Cryo-Save's container includes a temperature logger (where mandatory).
Shipping Info:The contract price includes shipping. Soon after birth, the collection kit will be picked up, on behalf of Cryo-Save, by a certified international courier service and taken to Cryo-Save's processing facility immediately thereafter (within 48 hours). There it will be checked, processed and cryo-preserved for further storage. The courier is available on weekends and holidays.
Cryo-Save are experts when it comes to shipping locally or internationally - currently their dry shipper (container used to ship frozen biological matter) travels between Europe and South Africa monthly to transport frozen samples for international and dual storage.
Cord Blood Processing Method
Cryo-Save uses automated laboratory processing to reduce possible contamination and increase laboratory capacity. The Cryo-Save processing method is the automated FDA approved Sepax II Cell Separation System system from the Swiss company Biosafe. The Sepax II is an automated cell separation system which relies on a light beam to sense the density gradient between different cell layers after the blood has been spun in a centrifuge.
In collaboration with Biosafe, Cryo-Save uses the specialised FAMCORD software protocol as well as the exclusive DeNovo 520-A processing kit which is sterile, functionally closed, and single-use.
Cord Tissue Processing Method
Cryo-Save has 4-purpose built clean rooms to process Umbilical Cord Tissue using a protocol that was first developed by Cryo-Save in 2010 after 2 years of extensive Research and Development.
In 2013, after further Research and Development in collaboration with the Cell Factory in Belgium, Cryo-Save developed a revolutionary fluorescent method to assess and confirm cell viability in the solid tissue of the Umbilical Cord itself.
Cryo-Save is the only Laboratory in Africa & Europe to test and confirm tissue sample viability prior to storage using the fluorescent method and provides photographic evidence thereof to each and every patient. This is the first of its kind in Europe and Africa and ensures that your samples are viable prior to storage.
Maternal Blood Testing
Cryo-Save performs the full spectrum of blood testing required in accordance with the Foundation for the Accreditation for Cellular Therapies (FACT - 6th Edition). These tests thoroughly screen for transmittable and infectious diseases/viruses that may be present in the bloods prior to confirming storage and/or transplant. The tests include a safety serology test for HIV, HBV, HCV, CMV and Syphilis. Should a positive test result prevent the storage or release of your sample, you will be refunded you process & storage fee.
Cryo-Save South Africa uses only independent pathology laboratories to perform their pre- and post- processing testing on all samples.
- • Cord Blood
- • Cord Tissue
- • Blood components stored are the "buffy coat" fraction containing white cells and stem cells, plus 2 contiguous testing segments.
- • We are in compliance with the DUTCH HUMAN TISSUE ACT (SAFETY AND QUALITY) - Register No. 108153L/EO. Cells from Cryo-Save are therefore acceptable for use in any International Transplant Programme.
Storage MethodThe stem cells are preserved using Sepax technology and their quantity and quality will be determined. They are then divided into two blood bags and preserved below -160°C in the vapour phase of cryogenic nitrogen. For additional safety, the bags can be stored at two physically separated
locations. Should the cord blood supplied not meet the minimum requirements, the parents may decide whether or not to store the sample to avoid any additional cost.
- • Final storage is in blood bags
- • Storage container is encased in over wrap
- • Temporary storage in quarantine freezer, then move to long term freezer
- • Computer controlled rate freezer is used to cool the stem cells
Licensing & Accreditation
All 6 of the Cryo-Save laboratories are managed daily by the live Cryo-Save Quality Management System in accordance with European Standards: Cryo-Save Tissue Bank (Stichting) which is AABB Certified and Cryo-Save Laboratories which is ISO 9001 and WHO GMP Accredited.
All laboratory procedures follow identical Quality Management Protocols, Standard Operating Procedures (SOP's) and thereby guarantee Quality Assurance according to International Standards across the group.
Cryo-Save South Africa endeavors to adhere to the international accreditation guidelines of: ISO 9001 ; AABB ; WHO GMP ; FAMHP. The new Cryo-Save South African laboratory is pursuing FACT-NetCord accreditation.
Clinical ExperienceGlobally, 17 cord blood stem cell samples have been released from their facilities to leading transplant and research centres:
14 samples have been released for clinical use:
1. 2004 Aplastic anaemia, autologous, Germany
2. 2007 Congenital immunodeficiency, allogeneic related (sibling), Portugal
3. 2007 Subarachnoidal haemorrhage, autologous, Bulgaria
4. 2009 Medulloblastoma, autologous, Spain
5. 2009 Acute Lymphoblastic Laeukemia, allogeneic related (sibling), Switzerland
6. 2009 Cerebral Palsy, autologous, USA/Duke University
7. 2010 Cerebral Palsy, autologous, USA/Duke University
8. 2011 Cerebral Palsy, autologous, USA/Duke University
9. 2011 Cerebral Palsy, autologous, Spain
10. 2013 Blackfan-Diamond anaemia, allogeneic related (sibling)
11. 2013 Cerebral Palsy, autologous, Spain
12. 2013Cerebral Palsy, autologous, USA/Duke University
13. 2013 Cerebral Pasy, autologous, Spain
14. 2014 Beta Thalassemia Major, allogeneic related (sibling), USA/Johns Hopkins Hospital
3 samples have been released for Diagnostic purposes:
1. 2008 Diagnostic purpose, Greece
2. 2013 Diagnostic purpose, Italy
3. 2015 Diagnostic Purpose, Spain
Community ServiceCryo-Save offers its Cost-free Family Donation Programme, free of charge, to families wishing to store their newborn's umbilical cord blood stem cells for a family member diagnosed with a life-threatening disease currently treatable by stem cells. This programme is specifically designed to offer families in need the opportunity to have the cord blood stem cells of their expected newborn child collected and saved without any charges, aiming to treat a diseased first line relative in the near future.
In order to qualify, the family member must be diagnosed with a disease that is currently treatable with umbilical cord blood stem cells, be a first degree blood relative, and have an oncologist/haematologist who agrees that the stem cells can be used for treatment. If eligible, Cryo-Save will provide the collection kit and process and store the newborn's cord blood sample, until needed, without any cost to the family.
- • Local storage services from R17 300
- • International storage services from R25 300
- • Dual storage services from R27 300
Along with the major International stem cell storage banks, we offer the security of an annual storage fee payment plan. Currently, storage fees are R200 locally and R500 internationally (incl VAT). This payment is made only ONCE a year. Your baby's stem cells may be stored with Cryo-Save for the rest of their life and this annual fee ensures the long term sustainability of the facility over this period regardless of regulatory, economic or political fluctuations.
- • Cryo-Save South Africa uniquely offers parents the opportunity to spread their investments by taking advantage of our DUAL STORAGE option in South Africa and Belgium.
- • Storage of umbilical cord tissue