Centre of excellence for cryogenic storage
Cord blood can be collected in almost every Italian hospital, but under Italian law the samples must be stored in laboratories abroad.
BioVault is the United Kingdom (UK) laboratory that SmartBank has chosen to preserve its umbilical cord samples. BioVault is a “Tissue Bank or Institute” licensed by the British Human Tissue Authority.
A tissue bank is “a unit of a public hospital, or a transfusion service, or a non-profit healthcare structure, or an authorized healthcare centre where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken”. The definition and regulations in European countries with national registers that have to observe WMDA (WMDA link) international quality and safety standards (as also described in Legislative Decree 191 of 19 August 2005).
To date BioVault is still the only bank to have the HTA (Human Tissue Authority) licence for both private and public preservation, since it is recognised and used by the British NHS (National Health Service) for public donation.
BioVault Ltd is the largest processing and storage bank in the United Kingdom, one of the first European laboratories to store stem cells from all over the world. Based in the Plymouth Hospitals NHS Trust (http://www.plymouthhospitals.nhs.uk), it has been set up as a UK limited company to comply with UK and international laws as well as the following quality standards:
- International GMP (Good Manufacturing Practices) protocol of the WHO (World Health Organization);
- ISO 9001 and ISO 13485 certified
- BL3 cleanroom and Grade A certified
- Accredited by Advancing Transfusion and Cellular Therapies Worldwide
- Accredited by JACIE (Joint Accreditation Committee) and FACT (Foundation of Accreditation of Cellular Therapy).
All procedures are conducted in a laboratory built to meet the latest and strictest standards for control techniques; aseptic treatments are carried out in a BL3 cleanroom (consisting of three concentric zones with positive outlet atmospheric pressure designed to eliminate the introduction, generation and retention of airborne particles). The laboratory is authorized to treat in quarantine samples with certain bacterial infections (e.g. streptococcus).
The cryopreservation takes place in the best refrigerators for this purpose, meeting all current approval and safety standards. They are capable of running for at least 20 days without mains electricity or under stress, such as significant seismic events.
| BioVault: samples stored and transplant performed | |
| Sampled stored | over 25.000 |
| Bone Marrow transplants | over 2.500 |
| Peripheral Blood Transplants | over 300 |
| Cord Blood Transplants | 7 including 3 for autologous use |
Cell vitality has been demonstrated for 15 years but this figure will presumably be updated over time*.
Storage is carried out for an initial period of 25 years. Later on it will be possible to extend the storage on the basis of scientific advances. SmartBank’s storage service includes the right to retrieve the sample (within 15 days of the request) from any accredited transplant centre worldwide.
If you store with BioVault you can also figure in international donor registers and opt for private donation.
All procedures are conducted in a laboratory built to meet the latest and strictest standards for control techniques; aseptic treatments are carried out in a BL3 cleanroom (consisting of three concentric zones with positive outlet atmospheric pressure designed to eliminate the introduction, generation and retention of airborne particles). The laboratory is authorized to treat in quarantine samples with certain bacterial infections (e.g. streptococcus).
The cryopreservation takes place in the best refrigerators for this purpose, meeting all current approval and safety standards. They are capable of running for at least 20 days without mains electricity or under stress, such as significant seismic events.
The Laboratory can be visited at any time, by appointment and after identification.
(* Broxmeyer H.E. “High-efficiency recovery of functional hematopoietic progenitor and stem cells from human cord blood cryopreserved for 15 years” PNAS 2003 Vol. 100, n.2, 645-650)
