|
Special
offers and
announcements
This
month’s
special
This
month we are offering 5% discount on all advance full
payment through PayPal. That’s
right, save $250 when you pay
via PayPal till Dec 30, 2009. And for those
of you choosing to have your treatment in
Ecuador, we
will increase it to a 15% discount to help you cover
your travel and stay expenses.
StemTech
Lab News
Supply
Challenges
One
of the reasons that we relocated StemTech Labs to Ecuador was
the anticipated ease of obtaining the placentas and
umbilical cords used to produce stem cells. We have
had an arrangement with the largest hospital in the
province to supply us with discarded placentas from
selected donors. Recently,
however, the directorship of the hospital has changed,
and the previous agreement has been reconsidered. The new
directors of the hospital have toured StemTech Lab, and desire to increase
their collaboration with us. They want to
start using our stem cells in their hospital. First, however,
they want us to get a license for our laboratory from
the Department of Health.
That
has presented a bit of a problem. When we started
our laboratory here, we checked with the health
department to see if we needed a license. They checked the
regulations, and told us that there were no regulations
regarding a stem cell laboratory. Since there are
no regulations requiring us to be licensed, no license
is available.
As
a result, we have had a problem lately getting enough
cords for production. This has made it
difficult to produce enough stem cells to meet the
demand. We
are working with another hospital to provide cords right
now, and trying to get a letter from the Health
Department verifying that it is ok with them that we
continue our work.
We
do have enough stem cells to provide those who come to
Ecuador to receive
treatments, but we are short of mesenchymal cells to
ship to the US. We
are working on several methods to overcome that
shortage.
FDA
Investigations
We
have been receiving numerous phone calls from undercover
investigators from the FDA. They have tried
to trick us into making statements that they consider
incriminating. If we
sound a bit suspicious at times on the phone, it is
because of the harassment from these
agents.
We
have written a letter to the FDA about our legal status,
requesting them to rebut any parts of it that they do
not agree with.
They received the letter by registered mail, and
have not responded, which legally constitutes acceptance
of our statements.
You may view our letter
here:
Recounting
We
have been re-evaluating the counting methods that we use
to count our stem cells. We do all of the
counting manually, using a microscope and a specially
counting chamber called a hemocytometer. We have
discovered that we have miscounted some of the earlier
batches of cells.
We had misidentified some of the non-stem cell
cells that are mixed with the stem cells, and as a
result, overestimated the amount of cells sent. We are satisfied
that we provided generous amounts of cells to each
customer, adequate for a treatment, and if we had it to
do over, we would not have provided any more cells than
we did.
However, to be accurate, we have decreased the
amounts of cells listed in a cell treatment. We will
now provide at least 5 Million umbilical cord blood stem
cells, and at least one million umbilical cord
mesenchymal stem cells. It takes more
than one cord to provide this many cells in most cases,
and as a result, and because of the demand, the price of
mesenchymal cells may rise in the
future.
We
plan on purchasing automated cell counting and sorting
equipment, but at the present time, the price of over
$100,000 is out of our budget.
Neurosurgery
Clinic in Loja, Ecuador
We
have joined forces with Dr. Amable Sanchez and his private
clinic (small hospital) in Loja Ecuador. Dr. Sanchez is a
neurosurgeon who teaches at the University of Loja
Medical School, and is Chief of the Department of
Neurosurgery.
He is willing to begin trials of using stem cells
for brain injuries, stroke, and spinal cord
injuries.
Some spinal cord injury patients have been
treated in Guayaquil, Ecuador, and
have had very good results. We hope to be
able to achieve similar results. More information
on using stem cell transplantation for spinal cord
injuries here:
http://www.transplantation.ru/spinal-cord-injury-treatment.php,
http://www.youtube.com/watch?v=G2dK3MDcfXI
These
are things that we do understand regarding stem cells,
and about mesenchymal stem cells in
particular:
1.
They can turn
into brain cells, and have done so in conditions such as
Parkinson’s disease.
2.
They can turn
into other nerve cells, and have done so in conditions
such as spinal injuries.
3.
The optic
nerve can be considered a part of the brain. It
contains axons from nerve cells going to the brain, and
from the brain. It also contains support cells,
called glial cells, which seem to be the key to many
brain and spinal cord repairs. IF the glial cells
are present, the nerve fibers (axons) from the brain are
often able to repair
themselves.
4.
Mesenchymal
cells can be turned into nerve precursor cells, which
then can turn into the other brain cells, including
glial cells. We don’t know for sure if it is
better to turn them into nerve precursor cells first,
before injecting them, or
afterwards.
Mesenchymal
stem cells are able to turn into blood and blood vessel
cells, and may support the formation of new blood
vessls, and possibly the repair of old
ones.
Patient
Results
We
have treated patients with cerebral palsy since our last
newsletter, and these patients have noticed definite
results.
These were with umbilical cord BLOOD stem cells,
and the patients are awaiting treatment with mesenchymal
stem cells, which have been shown in the laboratory to
convert to nerve cells, when they become
available.
One
patient with Type II Diabetes and blood sugars
around
(normal being 60-120) brought his blood sugar
down to 120 within a few days after receiving a stem
cell transplant.
Affiliate
Labs
Because
there is such a demand for our stem cells in the
United
States, we have created a plan to
provide collaboration in the creation of affiliate
laboratories in the United
States and other
countries.
We would like to begin by providing one
laboratory in each state. A lab in the
United
States could provide more types of
stem cells than we can from Ecuador,
because if a laboratory limited its business to only
intra-state commerce, it would be out of the
jurisdiction of the FDA. This would allow
it to culture stem cells, thus providing greater amounts
in each treatment.
At the current time, this is not allowed under
FDA regulations, which call a cultured stem cell a drug
or medical device.
In Intra-state commerce, a physician can produce
his own treatments, without lawful interference from the
FDA.
We
need your help getting out the word to
doctors
We
are holding seminars in the USA at the following
cities: Phoenix,
Arizona; Los Angeles,
California;
Ft. Lauderdale, Florida
Closing
notes
Thank you for
reading this month's issue of StemTech Lab
Monthly.
We'll see you
again soon.
Editor: Leonardo
Abello-Rode, Marketing Manager – StemTech
Lab
Our
Website: http://www.stemtechlab.com
Forum:
http://www.stemtechlab.com/phpbb
Published
monthly by:
StemTech
Labs
Questions,
Comments: editor@stemtechlab.com
Medical
question: MD@stemtechlab.com
Sales:
sales@stemtechlab.com
USA:
1-305-515-8137
Not your
subscription? Then
signup to our FREE monthly
newsletter
To
unsubscribe just reply to this email with the word
unsubscribe in the subject line
|
EMAIL
DISCLAIMER - USA
ONLY: The mesenchymal and umbilical cord blood
stem cells used in this study are human cells,
tissues, or cellular and tissue-based products
(HCT/Ps) as defined in 21 CFR § 1271.3(d). Under
21 CFR Part 1271, HCT/Ps are not subject to
licensure or IND requirements
if certain criteria are met (21 CFR § 1271.10).
These requirements include autologous use (use by
the cell donor), or if used for other patients,
the HCT/Ps must be “not more than minimally
manipulated” and labeled for use for “homologous
use only”. They may also not be used for a
purpose requiring their “metabolic” activity.
StemLab S.A. mesenchymal
and umbilical cord stem cells shipped to the
United States of
America have not
been “more than minimally
manipulated”. StemLab S.A. labels and
intends its cells which are used within the
United States of
America only for
homologous and non-metabolic
purposes. StemLab S.A.
does not interfere with the practice of medicine
by individual physicians who use StemLab products,
and who may do so according to their own medical
training and informed choice.
The
information contained in this message may be
privileged and confidential, protected from
disclosure, and/or intended only for the use of
the individual or entity named above. If the
reader of this message is not the intended
recipient, or an employee or agent responsible for
delivering this message to the intended recipient,
you are hereby notified that any disclosure,
distribution, copying or other dissemination of
this communication is strictly prohibited. If you
received this communication in error, please
immediately reply to the sender, delete the
message and destroy all copies of it. All rights
reserved. Publishing this information or
using it in any matter other than it is intended
purposed is strictly prohibited.
Thank You
"La información que contiene esta
comunicación es de naturaleza confidencial y puede
que contenga información privilegiada. Dicha
información es para el solo uso del destinatario.
Si usted no es la persona a quien se le dirige
esta comunicación o la persona que puede hacerle
llegar esta comunicación a su destinatario,
deseamos hacerle saber que el retener, diseminar,
divulgar, distribuir, copiar o cualquier otro uso
que se le di a esta comunicación y a la
información que la misma contiene, esta
estrictamente prohibida. Si usted ha recibido esta
comunicación por equivocación,
notifíquennoslo. Todo derecho
reservado.
Gracias
|
|