No, we do not store whole blood.
“The majority of banks remove red blood cells prior to freezing, primarily because these cells often burst during freezing and release iron from hemoglobin that can be toxic. The alternate to removing the red cells before freezing is to wash any broken cells out of the collection upon thaw. Removing the red cells also removes the donor's blood type (the ABO and Rh types). When cord blood goes from a donor to a patient for a transplant, the donor and patient can be compatible on all the HLA types used for transplant matching and still have incompatible red blood types.”
(excerpt from Parents Guide to Cord Blood)
15. Should I store the umbilical cord tissue as well as the cord blood?
BioVault has the entire infrastructure in place to store any type of human tissue including the umbilical cord tissue. Nevertheless we feel it is our duty to bring the following to the attention of our clients; The Wharton’s jelly that surrounds the blood vessels in the umbilical cord is a rich source of Mesenchymal stem cells. Mesenchymal stem cells are already being used in regenerative medicine and no one disputes their potential. However, cryogenics only works well at a cellular level.
In order to be able to preserve the mesenchymal stem cells, they would have to first be extracted and then frozen. This is a very costly and time consuming procedure and with the current technology not routinely possible. Freezing entire portions of umbilical cord without first extracting the mesenchymal stem cells, as is the current procedure among cord blood storage companies, causes them to die. The DMSO, the chemical used to prevent crystal formation inside the cell, cannot reach the individual cells and thus cannot prevent the crystal formation. These cells will in all probability rupture and die and be useless for future therapeutic use.
16. What is the recovery rate for BioVault’s method?
In spite of the much higher cost associated with manual processing, BioVault uses their proprietary manual volume reduction method which is a positive variation on the world renowned stem cell scientist Dr. Rubenstein’s description of it. Our methods are currently quoted as achieving a stem cell recovery rate of more than 95%. This is in comparison to automated systems; published studies by a leading provider of automated systems show mean MNC cell recovery rates ranging from 77.4% to 87.7% with a variability ranging from +/- 9.72% to +/- 27.8%.
Of course we are constantly monitoring the recovery rates of automated systems and will consider their use when their recovery rates exceed our current 95%.
17. What’s on the certificate?
BioVault was awarded JACIE accreditation in November 2011, an extremely proud achievement for us as we are the first private tissue bank to be awarded this accreditation in the UK. JACIE The Joint Accreditation Committee-ISCT & EBMT is a non profit body established in 1998 for the purposes of assessment and accreditation in the field of haematopoietic stem cell (HSC) transplantation.
BioVault holds an open ended, unconditional HTA licence which covers every aspect of all transplantable material for human application. For more detail concerning BioVault's HTA licence
(licence no: 11063)
The internationally recognised standard for an organisation's internal Quality Management.
(certificate no: GB04/62552)
Quality management standards for medical devices
(certificate no: GB07/72849)
BioVault's Flow Cytometers are externally quality controlled by NEQAS .
British Association of Tissue Banks
BioVault is an established member of the British Association of Tissue Banks
Biovault has also recently become a member of the ESBB, European, Middle Easter and African Society for Biopreservation and Biobanking. The mission of the ESBB is to advance the field of biobanking in support of research relating to healthcare, education and the environment.
Biovault has been issued the Certificate of Registration for the Community Trade Mark as of 24.12.2009 by The Office of Harmonization for the Internal Market. This is valid in all 27 countries of the EU.
Please find below few selected quotes from the final 'site visit inspection' report of 15 May 2012 by HTA. http://www.hta.gov.uk/_db/_documents/2012-03-07_11063.pdf
"Compliance with HTA standards"
"All applicable HTA standards have been assessed as fully met."
"The DI and CLHC have a good understanding of regulatory requirements. Staff at the establishment demonstrate a strong commitment to meeting HTA requirements and to the ongoing development of a culture of continuous improvement."
Records are owned by BioVault but are held in a fully-serviced commercial data centre under a commercial contract.
Records are multi-backed-up the system is resilient, robust, fast and infinitely expandable.
Record storage is full pre-paid for a 55 year period and access is guaranteed.
BioVault operates a fully compliant records system.
Future storage charges are escrowed and drawn down annually. The funds are controlled by an independent professional and not implicated should BioVault cease to exist and hence available for future storage.