| Section
1. Umbilical Cord Blood Stem Cells
Section
2. The Collection Procedure
Section
3. Cells Limited
Section
4. General and Miscellaneous questions
Section
5. Cells Labs
Section
1. Umbilical Cord Blood Stem Cells
1)
What are stem cells?
2) What illnesses can the cells treat?
3) What is the characteristic that enables
these cells to "cure" a diseased blood system, as
with leukaemia?
4) How likely is it that my child will ever
need these cells?
5) What is the possibility of matching with
in my family?
6) What happens to these cells after 20 years?
7) What is the difference between cord blood
stem cells, embryonic stem cells, and bone marrow stem cells?
8) Do you think people get confused between
obtaining stem cells from un-needed embryos, bone marrow,
and now umbilical cord blood? Is the confusion understandable,
or is at all the same science?
9) Is it possible to obtain stem cells later
in life?
1) What are stem cells?
They are a unique type of growth cell, the original building
blocks of life for the developing embryo in the womb. They
turn into the different types of cells needed to make up the
child, from heart muscles and skin tissues to red blood cells.
Once separated from the cord blood, they can be stored in
gas nitrogen, and can be multiplied in the laboratory.
They are brought out of storage if and when the person becomes
ill and requires stem cells’ transplant.
2)
What illnesses can the cells treat?
The
main use so far has been childhood leukaemia and some other
cancers, but potentially the cells could be used to treat
illnesses such as diabetes, strokes, multiple sclerosis, brain
and muscle diseases, Alzheimer’s and Parkinson’s diseases.
3)
What is the characteristic that enables these cells to "cure"
a diseased blood system, as with leukaemia?
It
is the renewing properties of the cells which allows them
to be used as a treatment. The diseased cells must be completely
removed by chemotherapy and in some cases radiotherapy. The
umbilical cord stem cells can then be given intravenously
to the patient and they will build a complete new blood system
and maintain it for years to come.
4)
How likely is it that my child will ever need these cells?
Hopefully
never. If you think about it as an insurance policy, you always
hope that you don’t have to use it, but if you do it’s there.
5)
What is the possibility of matching with in my family?
There
is a one in four (1:4) chance that siblings will match. This
ratio goes up exponentially for parents and grandparents.
6)
What happens to these cells after 20 years?
We
believe that the cells will be viable indefinitely. There
is no evidence to support that the cells will deteriorate
after 20 years. In fact, the first sample that was stored
was in 1979 and is still viable today. After 19 years, we
will contact our clients allowing them the option to continue
storing their sample.
7)
What is the difference between cord blood stem cells, embryonic
stem cells, and bone marrow stem cells?
a)
Stem cells from the umbilical cord are more flexible than
stem cells taken from an adult’s bone marrow. Umbilical cord
blood stem cells are the predecessors of adult stem cells,
and have the ability to divide into each type of cell, whereas
bone marrow stem cells may have a more difficult time dividing.
b)
Umbilical cord blood stem cells have a greater repopulating
potential than bone marrow stem cells.
c)
Bone marrow and peripheral blood stem cell collection are
painful and complicated procedures.
d)
There are also many instances when bone marrow or peripheral
blood stem cells cannot be used, which would mean finding
a donor.
e)
Embryonic stem cells are cells that are taken from a 0-14
day old embryo. They are the richest form of stem cell but
are associated with many ethical, religious, and legal issues.
8)
Do you think people get confused between obtaining stem cells
from un-needed embryos, bone marrow, and now umbilical cord
blood? Is the confusion understandable, or is at all the same
science?
There
is confusion as to the source of stem cells and these sources
are very different. Embryonic stem cells are a completely
different set of cells compared to umbilical cord blood stem
cells and they are regulated by the government. At the scientific
level the concepts are similar but embryonic stem cells raise
many legal, ethical and moral questions which umbilical cord
stem cells do not.
9)
Is it possible to obtain stem cells later in life?
Yes,
stem cells can be found in our bone marrow where they continue
to generate new blood cells throughout our lives. But cord
blood stem cells have a number of important advantages over
bone marrow. Cord blood stem cells are easier to obtain than
stem cells from bone marrow, and treatments using cord blood
stem cells can be less costly than bone marrow transplants.
Additionally, the collection of cord blood is a quick, non-invasive
and painless procedure with no risk to the mother or newborn.
More important, however, is the fact that cord blood stem
cells are a perfect match for the child they are collected
from, thus eliminating the difficult process of finding a
matching donor and minimizing the risks of rejection. Umbilical
cord blood stem cells have a 1:4 (25%) chance of being an
exact cell match for a sibling.
Section
2. The Collection Procedure
1)
How is the collection done?
2) What is in the collection kit?
3) Who actually does the collection?
4) What volume of blood needs to be taken?
5) What is the average amount of blood you
have received?
6) What do I do with the sample after collection?
7) Should I put it in the refrigerator?
8) Are there enough stem cells in the cord
blood for treatment?
9) Can the blood be collected from the umbilical
cord when it is cut already?
10) Is it also possible to collect the cord
blood when the delivery is taking place at home?
11) How long the blood sample can wait before
processing?
1) How is the collection done?
A
blood collection kit is issued to new mum long before she
goes into labour. This enables the midwife, or doctor, to
assist by extracting blood from the cord, after the baby is
safely delivered. Between 60ml and 100ml of blood needs to
be collected from the cord, and frozen within 72 hours. It
takes on average about three minutes and can not affect the
health of mum or baby. The umbilical cord is simply pricked,
and the blood flows into a normal blood bag.
2)
What is in the collection kit?
a)
A sterile blood collection bag (250cc) with CPD anticoagulant
and 16G needle
b)
Alcohol disinfectant tissues (4) and disinfectant
c) Sterile cotton wool
d)
An absorbent cloth (for transport)
3)
Who actually does the collection?
a) Ideally, your midwife or obstetric consultant will perform
the procedure.
b) In some cases, the father/partner may need to get more
involved, and may collect the cells himself.
4)
What volume of blood needs to be taken?
a) We generally ask for a minimum of 80 cc of blood to be
collected.
b) It is possible to test a smaller sample, but the likeliness
of attaining a sufficient sample is smaller.
5)
What is the average amount of blood you have received?
a)
The average is around 85cc
b) Smallest (with success) 50cc – largest 200 cc
6)
What do I do with the sample after collection?
Have
someone call DHL to arrange a pick-up at the hospital or home
if it is a home birth.
7)
Should I put it in the refrigerator?
Never
put the sample in the fridge or freezer. This will cause the
blood to start clotting. Always keep the sample at room temperature
until DHL arrives.
8)
Are there enough stem cells in the cord blood for treatment?
The
amount of cells necessary is proportional to the weight of
the patient, so the change is better for a child than for
an adult. But doctors are trying to increase in number the
stem cells present in the blood specimen.
9)
Can the blood be collected from the umbilical cord when it
is cut already?
Yes,
the umbilical cord is clamped and cut in the same manner,
as it would be for normal delivery.
10)
Is it also possible to collect the cord blood when the delivery
is taking place at home?
Of
course, but you have to give your midwife a set of the Umbilical
Cord Blood Collection Instructions at your next prenatal visit
for their review.
11)
How long the blood sample can wait before processing?
Cells
propriety developed, temperature controlled kit beside safe
transportation ensures viability of blood sample at least
for 96 hours. This assertion is based on our labs long term
experience in cryobiology having stored thousands of samples.
Section
3. Cells Limited
1)
Are you a private company?
2) Your experience?
3) How many successful transplants have you
been involved with?
4) What is babycells?
5) Are you affiliated with a hospital or research
lab?
6) What are the costs?
7) Do you issue a report after freezing the
sample?
8) Do you operate your own storage facility
or lease space from another facility/company?
9) Is there a storage facility in the UK?
10) What guarantees do you have against your
company going into bankruptcy and our family losing our cells?
11) What measures of security are taken to
ensure security of the samples?
12) How do you ensure client confidentiality?
13) What will you do with the cells as the
years go by?
1)
Are you a private company?
Yes.
Registered in England and Wales no. 5057305.
2)
Your experience?
We
have stored from all around Europe including all European
partner a total of 130,000+ samples.
3)
How many successful transplants have you been involved with?
To
date (March ’04) Life sciences group has been involved with
two successful transplants. One in The Netherlands and one
in Israel.
4)
What is babycells?
'babycells'
is a registered trademark of Cells Limited and our brand for
umbilical cord blood stem cells storage.
5)
Are you affiliated with a hospital or research lab?
No
6)
What are the costs?
a)
The cost is £125 inc. VAT for the kit and £995 for the storage
and processing.
b)
For clients outside the UK and EU, the costs are £175 inc.
VAT for the kit, and £1400 for storage and processing.
7)
Do you issue a report after freezing the sample?
We
routinely issue a certificate of storage, with the lab’s contact
details and storage details. If exact number of cells is asked
for, we can provide a report as such.
8)
Do you operate your own storage facility or lease space from
another facility/company?
We
have a storage agreement with the Life sciences group who
stores stem cells in Mechelin, Belgium.
9)
Is there a storage facility in the UK?
No,
and this is due to the fact that we have stronger resources
locatable in one place instead of having labs all over Europe.
10)
What guarantees do you have against your company going into
bankruptcy and our family losing our cells?
a)
We are backed by our European partners, and the group collectivly
operated in more than 30 countries..
b)
Our partner lab is financially supported privately and publicly.
c)
Our lab has made financial provision for each and every client,
through a company specialised in Cryo-preservation. The safe
storage over the agreed period is therefore fully guaranteed.
11)
What measures of security are taken to ensure security of
the samples?
a)
The laboratory is a highly secure facility with restricted
and limited access.
b)
Each client has a client ID which is generated the day a kit
is ordered. When the lab received the blood, a sample ID is
created, and each storage bag has an individual bar code.
All these numbers relate to the client and the sample and
are cross checked at every stage of the process.
c)
We store your one part of your sample at the Belgium lab and
the second part of it in Netherlands.
12)
How do you ensure client confidentiality?
a)
We feel that customer service and client confidentiality is
the most important part of our service.
b)
We operate under the Data Protection Act 1984.
13)
What will you do with the cells as the years go by?
Nothing.
We store your baby’s cells for his/her future use and that’s
it. We do not have anything to do with research and as the
contract states you are the only people with the right of
access to the cells. They are your property.
Section
4. General and Miscellaneous questions
1)
Can I get stem cells from a public bank if I need them?
2) Where can I donate instead of privately
storing?
3) Is collection available on the NHS?
4) Why are some midwives and consultants difficult
about collecting cord blood?
5) If a sample is required, what is the procedure
of thawing and transport?
6) How many times can the stem cells used?
7) Can the cells be successfully multiplied
in vitro, where for example the patient was large, for example
in the case of an adult?
8) Are there any additional costs for retrieving
a sample?
9) Is it better if the transplant is autologous,
i.e. your own, or is a "match" good enough from
a donor?
10) Given the current interest, do you see
these cells becoming a vital part of the every-day treatment
of serious illness in the future, if so, how far in the future?
11) I would like to view the agreement/contract
before committing?
1)
Can I get stem cells from a public bank if I need them?
This
could be possible, but would depend on finding a suitable
match which becomes increasingly difficult if you belong to
certain populations, such as ethnic minorities, or mixed raced
families.
2)
Where can I donate instead of privately storing?
At
present, you may be able to donate the cells, but you would
have to deliver your baby at one of the NHS hospitals with
their own labs.
i)
Northwick Park
ii)
Barnet
iii) Newcastle
iv) Dublin
v)
Glasgow
3)
Is collection available on the NHS?
Not
on any large scale. That’s because the NHS does not have the
resources to enter into a huge programme of collection and
storage. Some NHS hospitals are taking samples for research
purposes, in the hope that one day banks of Stem Cells might
be available for the whole population. The Government has
started a stem cell bank, but the "lines" of stem
cells produced for research will be from embryos.
4)
Why are some midwives and consultants difficult about collecting
cord blood?
a)
Experience has shown that it is not always possible to collect
enough blood from the umbilical cord or placenta for various
reasons, secondly it may not be possible to collect enough
stem cells despite the fact enough blood had been collected,
as such there are two common misconceptions in the medical
community. (1) Sometimes they think that if they don’t collect
enough blood or something goes wrong with the sample that
the patients are going to sue them, or hold them liable. This
is not the case, due to the fact that we have all our clients
sign agreements before their baby is born, which states that
the hospital or its staff will not be held liable in any way.
b)
(2) They sometimes think that this is a lengthy procedure.
Again, this is not the case. The entire procedure can take
between 5 and 10 minutes. When the midwife has not done it
him/herself they don’t realise how easy it is. Additionally
it is the same process as taking blood for a rhesus negative
mother, and the midwives are trained for that.
5)
If a sample is required, what is the procedure of thawing
and transport?
a)
If a sample is required, retrieval and transport is included
in the total service cost.
b)
We require the parents to request the sample in writing, and
we will arrange for the sample to be delivered directly to
your physician at your hospital.
c)
The thawing protocol will be sent to the physician at that
time.
6)
How many times can the stem cells used?
This
is a relative question, and depends on the size of the sample.
The sample can definitely be used at least twice because there
will be two vials available. Some samples are stored in more
than two vials. Additionally future amplification will allow
more treatments.
7)
Can the cells be successfully multiplied in vitro, where for
example the patient was large, for example in the case of
an adult?
In
vitro multiplication is currently in the experimental phase
but in the future it should be possible to multiply cells
in vitro so that a sufficient dose can be obtained for all
treatments and individuals.
8)
Are there any additional costs for retrieving a sample?
There
are no hidden costs. Retrieval and transport are included
in the service fee.
9)
Is it better if the transplant is autologous, i.e. your own,
or is a "match" good enough from a donor?
The
ideal transplant is autologous but there is an increasing
amount of evidence which suggests that a basic match or even
mismatched cells could provide useful transplants. Further
work is needed in this area to truly understand the immunology
of these cells.
10) Given the current interest, do you
see these cells becoming a vital part of the every-day treatment
of serious illness in the future, if so, how far in the future?
The
current storage of umbilical cord stem cells at birth means
that we are already at the stage where they play a vital role
in the treatment of deadly disease. We feel that this technology
will increase to be common-place in the future (5-10 years)
in the treatment of a whole range of diseases.
11) I would like to view
the agreement/contract before committing?
Click
here to view the agreement. (PDF document)
Section
5. Cells Labs
1)
Is the laboratory accredited? And by who?
2) Who carries out the quoted inspections
of the laboratory?
3) Is the blood sample tested for diseases
and contamination?
4) What is the sample stored in? i.e. vials
or bags
5) How long does it take from collection to
being frozen?
6) What if the sample is collected during
the weekend?
7) What temperature is the sample frozen at?
8) How are the cells stored, by deep freezing,
and is this procedure already well established?
9) How are the stem cells separated from the
cord blood, and what percentage are they. How many stem cells
can be collected from the blood sample?
1)
Is the laboratory accredited? And by who?
Life
Sciences Group: Yes, the laboratory is accredited by the Belgium
Health Authority, and The Ministry of Economy under ISO 17025.
2)
Who carries out the quoted inspections of the laboratory?
Life
Sciences Group: An official from the Belgium Health Authority
conducts yearly visits. And the last visit to the laboratory
was in April 2004.
3)
Is the blood sample tested for diseases and contamination?
a)
The sample is tested for contamination.
b)
We also carry out blood tests for Syphilis, HIV, Hepatitis
B, and Hepatitis C.
4)
What is the sample stored in? i.e. vials or bags
A
minimum of 2 vials.
5)
How long does it take from collection to being frozen?
a)
There is a 72 hour window period for safe transport of the
cells from the hospital to the laboratory.
b)
The laboratory will process the sample as soon as they get
it. The faster the sample arrives to the lab, the faster it
goes into storage
6)
What happens if I have my baby over the weekend?
DHL will pick up the sample on Monday morning. As long as
the sample is kept at room temperature, it will remain viable.
7)
What temperature is the sample frozen at?
-196º
Celsius
8)
How are the cells stored, by deep freezing, and is this procedure
already well established?
The
cells are stored by slowly cooling them to the temperature
of gas nitrogen which is -196 degrees Celsius. Chemicals
are added to prevent damage to the cells during the freezing
process. Once frozen the cells are completely stable and can
be kept in this state for many years. The technology used
is very well established in the field of IVF, but embryos
can not be stored for anything like as long as stem cells.
9)
How are the stem cells separated from the cord blood, and
what percentage are they. How many stem cells can be collected
from the blood sample?
This
largely depends on the volume of blood collected but a range
of 50,000 to 200 million stem cells can be obtained, representing
about 0.1-3.0% of the total number of cells. The cells are
obtained by standard centrifugation techniques which allow
the unwanted cells to be largely removed and the stem cells
to be concentrated.
|
