Wednesday, October 27, 2010

TENS OF THOUSANDS OF STEM CELL SAMPLES COULD BE REJECTED BY DOCTORS.

SMART CELLS INTERNATIONAL

STEM CELL COLLECTION AND STORAGE
PRESS RELEASE

October 27, 2010.

TENS OF THOUSANDS OF STEM CELL SAMPLES COULD BE REJECTED BY DOCTORS.

A test which measures the number of stem cells in cord blood samples should be made mandatory to prevent heartbreak amongst families for whom stem cell transplantation may be the last chance to save a life.

London-based Smart Cells International Ltd (SCI), the UK’s longest-established stem cell banking service, says thousands of families have no way of knowing whether samples stored for future use with some private banking services will actually work, because the test has not been carried out.
                                       
The test measures a marker on stem cells called CD34, is well-known to stem cell transplant experts and referred to as “the gold standard”, and is carried out by SCI at the time of sample storage – but SCI believes it is the only private UK stem cell banking service to carry out the test, and has been doing so since it launched in 2001.

SCI has consulted an expert in the field – working in a busy NHS Transplant unit - who said samples harvested and then stored without CD34 testing would be summarily rejected by doctors carrying out stem cell treatment.

“Fundamentally, the CD34 test measures the number of stem cells in a sample, and allows doctors planning and then carrying out stem-cell transplants – or ‘infusions’ – to know if and adequate dose is available,” said Amanda Cool, General Manager of SCI.

“As in everything involving medical treatment, there needs to be a minimum dose; in the case of stem cell infusion, that dose is determined according to the weight of a patient and the particular medical situation. If the dose of stem cells is too low, then a bigger dose has to be sourced either from other stored samples, or from other sources such as bone marrow.

“But if CD34 testing has not been carried out, then an accurate measurement of the dose of stems cells cannot be guaranteed.  In fact, transplant doctors will typically not accept cord blood samples for transplant unless CD34 has been carried out and the results provided.

“As well as being a waste of money, it could also mean heartbreak for families who only find out too late that a sample had too low a dose of stem cells, but, because stem cells can be used to re-build the immune and blood-making system after chemotherapy, this could potentially compromise clinical outcome.

“For any stem cell banking service which has not adopted the CD34 test, it could also be hugely litigious: there are tens of thousands of samples stored in the UK, and as well as not knowing the dose of stem cells they may also be rejected by doctors. The only way through it would be to retrospectively test samples at huge cost.

“In a nutshell, stored samples which have not been subject to CD34 testing have limited use. It is like going to your local GP for a prescription of antibiotics, but knowing neither the dose required nor the potency of that dose.

“While the Human Tissue Authority (HTA) inspects stem cell banking and their processes, there is no mandatory test for CD34. SCI’s submission that CD34 should become standard procedure in the private transplant sector is a valid one.”

SCI is the only private UK stem cell banking service to have been involved in successful stem cell transplants.

“Because CD34 testing is considered to be a key element of the storage process, we had never previously recognised that our approach was unique. When we discovered that we are, to our knowledge, the only private stem cell banking service in the UK to apply CD34 testing we were extremely surprised, because samples not tested to CD34 are likely to be rejected by transplant doctors,” said Amanda Cool of SCI.”

Ends 

Further information:
Iain Macauley
+44 (0)7788 978800
Notes:

Smart Cells, formed in February 2001, collects stem cells on behalf of families worldwide and stores samples at its labs in West Drayton near London Heathrow Airport in the UK. Smart Cells’ lab provides cord blood preparation and storage in an environment designed to comply with all current and foreseeable European medical guidelines and practices.

Stem cell storage expert Smart Cells International has been named London’s Life Sciences Exporter of the Year at the London Export Awards 2010,

Smart Cells International is fully licensed by the Human Tissue Authority and holds licence no 22522.



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