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Securing the future of your family’s health

BioVault Family Brochure.indd 1 29/02/2012 12:11



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Welcome to

Biovault Family offers parents the chanceto save their baby’s cord blood at thetime of birth.

Cord blood is the blood that is contained within the placenta and the

umbilical cord. The umbilical cord, as you know, connects the baby inside

the womb to the mother’s placenta. Through the cord the baby receives

all the nutrients and oxygenated blood it requires during its development.

The cord is also used to take away from the baby all the waste

products such as carbon dioxide and deoxygenated blood back to the

mother via the placenta. Once the baby has been born the cord is cut

from the baby. The cord and placenta both still have blood within them

that contains stem cells. These stem cells are fully developed and, inbiological terms are described as adult stem cells.

So what are stem cells?Stem cells are a class of undifferentiated (that is they are not biologically

“committed” to become particular tissue), cells that are consequently

able to differentiate into specialized cell types. Commonly, stem cells

come from two main sources, the embryo (embryonic stem cells) and fully

developed or adult tissue (adult stem cells). Cord blood contains adultstem cells. The stem cells in the cord blood are the building blocks of the

blood and immune system.

Every day, science pushes back the boundaries of what we know

about how our bodies work and how diseases affect us. Every day, real

scientic advances and medical discoveries hit the headlines, offering

new scope to improve the quality of our lives.




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Biovault

As the building blocks of

our bodies, stem cells play

a vital role in keeping us

healthy and disease-free.

When a baby is born there is a

unique opportunity to collect the

baby’s umbilical cord blood that

contains an extremely rich source

of stem cells. The cord blood

is normally discarded as clinical

waste but an increasing number of

parents are opting to collect and

store their child’s cord blood stem

cells at birth. In recent years, the

number of conditions that stem

cells can treat has vastly increased;

who knows what the future holds?

Biovault has unparalleled expertise

in the collection, processing

and storage of stem cells fromumbilical cord blood, preserving

their potential for the future. As

a full service tissue bank storing

many types of human tissue

for transplant, Biovault is fully

accredited by the UK’s Human

Tissue Authority. We can and

do store cord blood samples for

families in the UK, across Europe

and further aeld and mostimportantly in a highly ethical way.

Our cutting-edge UK facilities

and industry-leading processes

mean that Biovault has the highest

recorded rate of stem cell recovery

in the industry, exceeding 95%.


the UK’s leading tissue bank

This publication aims to provide clear, accurate and factual

science-based information on umbilical cord blood collection,

processing and storage to help families make an informed

decision as to whether it is right for them. This document isprovided to a wide range of interested individuals so should

you have any questions about stem cells and their potential,

our comprehensive website has much more information

United Kingdom: www.Biovaultfamily.co.uk

Hong Kong: www.Biovaultfamilyhk.com

and our team of experts are standing by to help

United Kingdom: +44 (0) 1752 753723

Hong Kong: +852 2851 2860




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Adult (fully developed)

haematopoietic (blood) stem cells

found in low concentrations inblood and high concentrations in

bone marrow have been used for

years to treat diseases such as

leukaemia, sickle cell anaemia, and

other disorders of the blood. These

cells are capable of producing

all blood cell types, such as red

blood cells that carry oxygen and

white blood cells that ght disease.

Although possible, difculties

arise in the extraction of these

As stated, the blood that remains

in the placenta and umbilical cord

after birth is very rich in valuablestem cells. If collected and stored

correctly these stem cells could

possibly be used in the future to

treat that child or, if the match is

correct, a sibling as there is a 1

in 4 chance of a match between

biological brothers and/or sisters.

As an example, if a child was

unfortunate enough to develop

cancer of the blood the umbilical

cord blood stem cells of that child

cells through the use of invasive

bone marrow harvests particularly

in patients that are already ill.Stem cells in the normal blood

flowing around the body occur in

too low a concentration without

difcult medical procedures, but a

wide cross-section of stem cells

including haematopoietic stem

cells are found in the umbilical

cord and placenta in high

concentrations. Although this

cord blood can be preserved it is

normally discarded as waste.

Why storeumbilical cord blood?




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would probably not be used to

treat that child as there is a genetic

disposition to that disease present

in the stem cells. However, if a

sibling’s cord blood was a suitable

match a stored sample could be

used to treat the sick child.

There are a large number of clinical

trials and research being performed

looking into the potential use of

stem cells to treat many different

diseases. Clinical trials are being

undertaken that look into the use

of stem cells to treat autoimmune

diseases (such as diabetes,

Crohn’s disease, rheumatoid

arthritis, lupus), cardiovascular

diseases (such as heart attacks,

strokes, cardiovascular repair),

neurological diseases (such asspinal cord injury, cerebral palsy,

Alzheimer’s disease). Some of the

clinical trials are looking at the use

of autologous (using one’s own)

stem cells to treat the disorders

while other trials are looking at

using allogeneic (using another

person’s) stem cells. The number

of medical applications for stem

cells is rising fast as research

continues apace.

Five years ago, the chance

of a child needing stem cells

throughout their lifetime to treat a

medical condition was around 1

in 4000 but today, with the huge

advances in stem cell therapy, this

has risen to 1 in 450, this gure

only takes into account the currenttherapies actually undertaken

using stem cells. With research

continuing into a wide range of

medical conditions, the chances of

a child needing their umbilical cord

stem cells will only increase.

The process of collecting umbilical

cord blood poses no risk to mother

or child yet the potential future

benets are extensive. Stem cells

collected from umbilical cord blood

at birth are an exact genetic matchfor that child; however, not only

does this mean that the stored

stem cells can be used to treat

the individual without worry of

rejection, there is also that 1 in 4

chance that they will be a match

for a sibling.

Although the concept of tissue

banking is simple – prepare, freeze

and store – the processes behind

it are complex. This is why Biovault

has developed a pioneering

approach; our processes havereceived widespread acclaim,

being described as the gold

standard in the industry. Since

its creation in 2002, Biovault has

established a strong expertise in

the recovery of stem cells from an

umbilical cord blood sample and

currently has the highest published

rates of stem cell recovery of any

tissue bank in the UK.


The birth of a child is an exciting,

life-changing event for parents. It is also an

event that presents a unique opportunity to

help safeguard the child’s health in the future.

Read more about Biovault’s pioneering approach to processing and the ethical storing of umbilical cord blood and stem cells over the page.




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Biovault specialises in

the storage of human

tissue and cells fortransplantation. It is the

largest private tissue

bank and the only one

that provides a full tissue

banking service to the

NHS.

granted us an unrestricted licence

that allows us to process and

store all transplantable material for

human application, one of only a

handful of tissue banks with this

breadth of capability.

Biovault has nearly a decade of

experience as a clinical tissue

bank, processing and storing both

human tissue and cells for use in a

wide range of medical and surgical

applications. We are the tissuebank for the NHS South-West

Peninsula Transplantation Service

and we have unrivalled facilities

for the processing and storage of

umbilical cord blood. In addition to

our expertise in the eld of stem

cell recovery and storage Biovault

also works closely with public and

private clinics and hospitals to

store and supply a wide range of

tissues for medical applications.

Parents rightly expect the best

when it comes to their child’s cord

blood sample. Biovault is a leading

tissue bank in the UK, setting theindustry standard with its rigorous,

ethical approach and high-quality

processes.

At our cutting-edge facilities

Biovault has the capacity to store

over one million human tissue

samples in a tightly controlled,

safe and secure environment.

The Human Tissue Authority has





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Biovault?Biovault has built an unmatched

expertise in the processing and

storage of stem cells for clinical

use, and our unrivalled and unique

techniques mean that we have the

highest published rates of stem

cell recovery from umbilical cord

blood of any tissue bank in the UK,

exceeding 95 percent.

As just a part of all the tissue

samples stored at Biovault it’s cord

blood inventory is over 22,000collections from more than 10

countries. Biovault has released 6

cord blood stem cell transplants

on behalf of private clients, 2,500

bone marrow stem cell transplants

to private clinics for patients that

did not have an option to store

and use umbilical cord blood and

320 stem cell transplants sourced

from mobilized peripheral blood on

behalf of the NHS cancer treatment

programme. All the tissue provided

for transplant has resulted in 100%

engraftment success as of January

2012 meaning that the stored

samples have successfully been

transplanted in all cases which

is the ultimate measure of tissue

banking. Biovault does not only

provide just-in-case tissue banking;

it is improving quality of life for

a large number of people on a

regular basis right now.

Biovault’s industry-leading

laboratory facilities provide clientswith detailed reports on the quality

of their sample. Our highly trained

technicians build a comprehensive

picture of the condition of the

sample through extensive testing,

ascertaining the number of stem

cells present in a sample and their

suitability for storage and later use

in treatment. We also source full

microbiology/virology testing from

internationally recognised and fully

accredited laboratories.

At Biovault, we are proud of our

highly ethical business practices

which ensure the safety and

security of our clients’ samples,

both now and in the future. While

many private tissue banks usepre-paid storage fees paid by

customers for the future storage

of samples to fund their day-to-

day business, Biovault follows a

more ethical approach; we arrange

that all funds are held in escrow.

In simple terms this is a separate,

independent, protected account

which is only authorised to release

funds for one specic purpose.

This allows Biovault to draw down

only one year’s portion of future

storage charges, thereby ensuring

sufcient funds are always available

to cover the full-term storage of

clients’ samples, safeguarding

against economic instability.

Quite simply, Biovault is at the

cutting edge. We have unmatched

breadth of capability in processing

and storing human tissue, including

stem cells and cord blood, for awide range of clinical applications.

If you choose to store your child’s

cord blood with Biovault it will be in

the safest possible hands.

Why




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Biovault Family how ourGetting

startedOur customer care team are

standing by to answer any and all

questions you might have about

collecting and storing your child’s

umbilical cord blood. If you decide

that you would like to go ahead

with the collection all you initially

need to do is call us. We will thensend you our information pack.

This will include the consent form

(to give written permission for

us to collect, process and store

your child’s cord blood on your,

and their, behalf), our health

questionnaire (to allow us to

handle the blood in the appropriate

manner) and your contract. You

will need to read and, once entirely

happy, sign all documents then

return one copy of each to us.

You will need to check with your

doctor or midwife who will be

delivering your baby if they will

collect the cord blood for you. If

they will not perform the collection,

simply call us and we will put

you in contact with a healthcare

professional who can collect the

blood for you.

Once we have received all the

signed documents and the health

questionnaire has been reviewedby our company doctor, we will

send you your Biovault Family cord

blood collection kit 6 weeks before

you are due to give birth. You will

need to keep this with the bag

that you will take with you to the

hospital when you are in labour.

Collecting your

Cord BloodOnce your baby has been born

the cord blood can be taken from

the placenta and umbilical cord.

This is only done after the cord

has been clamped and cut and the

midwife is assured that mother and

baby are well; these two individuals

are the number one priority andin some exceptional cases it may

not be possible to collect the cord

blood.

The collection can take place

either while the placenta is still

within the womb (in-utero) or after

the placenta has been expelled

(ex-utero). In addition, your

selected healthcare professional

will also take a small sample of

the mother’s blood that must be

tested for viral infections that could

affect the cord blood sample. The

results of this testing allow us to

deal with the long-term storage of

the cord blood and to inform the

clinician should the cord blood

be used in a treatment.

Biovault provides its clients

with a CE Marked Umbilical

Cord Collection Kit that

contains everything your

healthcare professional

needs to collect the cord

blood sample. Once thecord blood and maternal

sample have been taken the

documentation is completed,

the samples are hermetically

sealed for transport and the kit

returned to you, the parents.

You will then need to call our

customer care line to arrange

for collection and dispatch to

Biovault. This needs to be done

quickly as the shortest possible

transit time is best for the cord

blood and it is also important that

the samples are kept at room

temperature at all times. Our

Collection Kits have been specially

designed and manufactured by us

to protect and preserve the sample

during transport.

The umbilical cord blood sample is

transported by courier to Biovault’s

cutting-edge UK facilities. Although

cells are still viable 72 hours after

collection a sample should arrive at

our laboratory after no more than

48 hours. Once the cord blood

sample arrives, the kit is unpacked

and the sample assigned a unique

barcode, it is then prepared for

transfer into a sterile environment

for processing. Our technical

website will provide you with some

idea of the processing and facilities

at Biovault.





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service works Testing your

Cord Blood The cord blood is tested to ensure

it has not been contaminated

and also to assess the number

of stem cells present prior to

processing. Biovault, in common

with all public cord blood banks

and the majority of private cord

blood banks, processes the cordblood to reduce the volume for

storage. This process simply

removes the unwanted fractions

of the whole cord blood, these

portions being of no use, or

Storing your

Cord BloodDuring processing, a

cryoprotectant (which prevents

damage to the sample as it is

frozen) is added to the sample

which is then transferred under

aseptic (essentially sterile)

conditions to a barcode labelled

storage bag and prepared forfreezing. A small sample of

the ’waste products’ from the

processing of the cord blood are

stored alongside the main sample

as these can be used to test the

sample prior to its transplantation.

The sample is placed into a metal

canister, which is protected with a

tamper-evident seal and transferred

to a controlled-rate freezer. The

sample is cooled to -140ºC in a

controlled manner to prevent ice

crystals forming within the cells

and damaging them. -140ºC is

chosen as the initial end-point

for freezing as it is below the

critical temperature where all the

physical changes that occur during

freezing have completed. Once

this temperature is reached the

samples are temporarily stored

at -160ºC before, once a day,

the freezers are opened and the

canister is placed in its nal storage

position at a temperature below

-185ºC.

potentially detrimental, in the

transplant scenario. The cord

blood unit, once thawed, is ready

for immediate transplant.

A tiny sub-sample is taken to

assess the total number of

nucleated cells (which includesa wide population of adult stem

cells), the number of CD34+

cells (a particularly valuable,

undifferentiated type of stem cell)

and also the viability of these

cells (essentially a measure of

the condition the cells are in at

the time of processing). We will

provide you with a full report

once your baby’s cord blood

sample has been successfully

processed and stored and we

have all the test results.

During processing cells

such as red blood cells

are removed while the

important white blood

cells, which includes the

stem cells, are retained.

Biovault’s industry-leading

techniques ensure that

the loss of valuable

transplant material

is minimal. At this

point the sample

is prepared forfreezing.




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Using your Cord Blood

Your child’s cord blood

will only be issued for

use on direct, written

instruction from you

(until the child reaches

the age of consent); it

will be used for no other

purpose.

If you need to use your sample allyou would need to do is call us

and supply us with the contact

details of the consultant who will

be performing the treatment. We

can take care of the rest. We can

transport the sample to anywhere

in the world and have special

shipping containers that are

validated to keep the sample frozen

in similar conditions to the long

term storage for up to 5 days; with

special arrangements it is possible

to get one of these containersanywhere in the world in less than

48 hours.





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How does the process work?

We will send you an information pack that will contain

everything you need to read, complete and return

to us in order to join Biovault Family. Once you are

entirely happy and we have received everything we

will then take the rst payment for the kit. We will then

send you a collection kit 6 weeks before your due

date for you to take to the hospital when you go intolabour.

How do you plan for the day

of collection?

When you go into labour and are using a private

healthcare professional for the collection you will

simply need to ring the number they have provided

you with and inform them that you have gone

into labour and are either in hospital or, alternatively

that the midwife is in attendance.

What happens after Biovault

receives the cord blood?

Once we have successfully processed and stored

the stem cells we will contact you to let you know

everything is OK. Once all the test results have been

reported we will contact you for the nal payment

and then send you your baby’s stem cell storage

certicate.

What tests do you carry out

on the mother’s blood?

We are required by the regulations

in the UK to test the mother’s

blood for;

•

HIV I & II• Hepatitis B & C

• Syphilis

• HTLV

(human T-Cell

lymphotrophic

virus)

When should you rst

contact Biovault?

At any time you feel is right in making your choice

of bank, but after you have had your 20 week scan. Then it is a case of the sooner the better to ensure

that we have everything in place before your baby is

born. You can call us or request through the website

for us to call you.

When should you ‘apply’?

Once you have decided that you would like to use

Biovault Family for the safe storage of your baby’s

umbilical cord blood stem cells. Simply call us and

we will take you through the process.

Frequently Asked

Questions““




Biovault LtdPlymouth International

Medical and Technology Park,

24 Brest Road,

Derriford,

Plymouth,

PL6 5XP,

United Kingdom

Tel: +44 (0)1752 753723

Fax: +44 (0)1752 779777

Email: [email protected]

www.Biovaultfamily .co.uk

Biovault Hong Kong Ltd

Tel: +852 2851 2860

Fax: +852 2851 2859

Email: [email protected]

www.Biovaultfamilyhk.com

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