XCell-Center

Institute for Regenerative Medicine

Information for patients

Diabetes Mellitus treatment with autologous adult stem cells from your own bone marrow
 Diabetes Mellitus
Diabetes Mellitus (DM) is a group of metabolic disorders
of a chronic nature characterized by a common element,
hyperglycemia, which contributes to the development of
macrovascular, microvascular and neuropathic complica-
tions; making it one of the major causes of mortality in
developed or developing societies. It affects a great
number of people, with a 'progressive' increase of Type
1 DM and an 'explosive' increase of Type 2 DM. The WHO
relates this to population growth, ageing, unhealthy
diets, obesity and sedentary lifestyles. The same hap-
pens with emerging Type 2 DM associated to child obe-
sity. All these represent very serious personal and public
health problems.
The cause of diabetes remains a mystery although
genetic and environmental factors such as obesity and
lack of exercise appear to play roles.
There are two major types of diabetes:
Diabetes Mellitus type 1 or insulin dependent Diabetes
In the development of this disease, genetic, infectious and
immunologic factors are involved, which trigger the destruction
of pancreatic cells in charge of producing insulin.
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Diabetes Mellitus type 2 or non-insulin dependent
Diabetes
In this kind of disease there is a genetic component that
at about the age of 45, alters the way in which insulin is
formed and as a result, prevents effective action of
insulin. This phenomenon is known as Peripheral Insulin
Resistance, i.e. the areas where insulin has to bind to
body cells (receptors) do not recognize it and as a result,
insulin fails to bind or binds poorly.
Common Diabetes Mellitus consequences
Heart and Vascular diseases
Eye and kidney complaints
Poor vascularisation
Damage to nerve cells (neuropathy)
Diabetic feet
High susceptibility for infections
Erectile penile dysfunction
Treatment
Elevated blood glucose levels can eventually lead to damage
in every part of the body. That is why it is important to treat
the diabetes by getting the blood glucose to a normal
level. However, over a longer period complications still
appear.
Besides conventional treatments, stem cell therapy can
be used to treat the insulin producing cells in the pan-
creas thus reducing insulin use, and average common
sequels of diabetes mellitus.
About Stem Cells
The discovery of the stem cell has lead to a revolution in
modern medicine. Stem cells are in fact, the "smart cells"
of our bodies. These cells migrate to injured areas with-
in the body and transform themselves into new tissue
cells that replace the damaged ones. The body repairs
itself by continuously producing new cells and tissues in
this manner.
Stem cells have the capacity to multiply and to renew
themselves almost indefinitely. This contrasts with nerve
cells, muscle cells and blood cells, which cannot multiply
themselves and have limited life spans. Stem cells can
also develop into specialized cells.
 Stem cells from the bone marrow can develop into car- The XCell-Center medical team approves you for
diac muscle, as well as liver, brain, nerve, fat and skin tis- treatment.
sue. Examples of bone marrow-derived stem cell devel- Stem Cell
opment are illustrated on this page. In DM 2 patients, Your bone marrow contains a sufficient quantity of
these stem cells may grow into new tissue, new blood viable stem cells. This is assessed during the pro-
vessels that improve circulation, or produce stimulants Stem Cell cessing phase.
e.g., hematopoietic stem cell
that activate non-active insulin producing cells.

Specialized Cell
The XCell-Center Diabetes Mellitus Treatment
(e.g., neuron)

The entire procedure consists of the following phases: Liver Adult Stem Cell
eligibility, stem cell collection and processing, stem cell marrow. A few days prior to treatment, the stem cells will
treatment, and follow-up. be isolated from bone marrow taken from your pelvic
Skeletal muscle
bone (iliac crest).
Brain
Objectives
The goal of this treatment is to repair damaged tissue or Eligibility phase Bone marrow
to reactivate existing cells, with the ultimate goal of
improving vascularisation and reducing insulin. If you meet the following conditions, you are eligible for
Blood cell Epithelial cell
treatment:
Type of treatment
Neuron
The XCell-Center diabetes procedure employs autolo- Diabetes Mellitus type one or two diagnosis based
Cardiac muscle
gous adult stem cells. These cells are collected from your on your medical history, blood glucose values and
own bone imaging material such as MRI.

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 These pictures show the Bone Marrow Collection Procedure

Stem Cell Collection and Processing

Prior to scheduling bone marrow collection, you will be
asked to fill out the patient consent form. This form
grants explicit written permission for bone marrow col-
lection.

You must discontinue using any blood diluting medica-

tions at least 10 days before your collection date. You
should consult your physician before discontinuing the
use of blood diluting drugs.
Arrival at XCell-Center Preparation Application of local anesthetic

When we greet you on the collection day, we'll have

everything prepared to begin collection and make it com-
fortable for you.

Your physician will collect approximately 150 - 200 ml of

bone marrow from your hip bone.

Disinfection of the collection site Needle insertion into the hip bone Sample collection
(iliac crest)

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 Stem cell collection is performed as an out-patient pro-
cedure under local anesthesia in sterile conditions. It is
comparable in pain to a dentist visit. During the collec-
tion, you will barely feel the needle insertion into your
hip bone. Afterwards, the collection site might look like
a "blue spot" and be a bit painful for 3 - 4 days.
Normally, there are no other side-effects. Theoretically,
there is a small risk of infection. We minimize this risk by
working in a sterile environment.
Within 48 hours, the stem cell samples are processed
and quality tested by a highly specialized laboratory in
totally sterile, clean room conditions. Since they are kept
in sterile tubes and never come into contact with the air,
these samples cannot be contaminated.
Bone marrow processing and quality testing consists of:
Stem cell isolation - stem cells are separated from
the red blood cells and blood plasma.
Stem cell counting
Stem cell vitality measurement
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Stem cell processing results are documented in an
analysis report.
The result is positive if:
There are more than two million (2,000,000) CD34+
stem cells present.
The CD34+ stem cells have a vitality greater than
80%
Positive isolated stem cell samples are stored in sterile
tubes at -196°C in liquid nitrogen.
Stem Cell Implantation
Your high-quality stem cell sample will be implanted into
the pancreas under local anesthesia using angiography
and directly injected into damaged area like leg muscles.
1. Angiography
A catheter will be inserted into the femoral artery in your
pelvic region, then guided to the arteries that supply the
pancreas using X-ray imaging. Next, the stem cells will
be injected into the artery. Once the stem cells have
been implanted, the doctor will remove the catheter and
compress the entry site. You will be awake during the
entire procedure which takes about 90 minutes.
Immediately after treatment, you will spend about three
or four hours in our recovery room for observation.
 Possible Adverse Events from the treatment This price includes:

Bleeding (rare) Bone marrow collection and transportation

Slight burning sensations due to contrast medium Stem cell processing, storage and transportation
(common) Stem cell administration
Allergic reaction to contrast medium (very rare)
XCell-Center medical fees
Infarct due to dislodging of plaque within an artery
(very rare) XCell-Center administrative fees

Treatment advantages This price does not include travel expenses such as
airfares and meals, or accommodation costs.
Simple
Out patient 2. Direct injection
Low overall risk
For treating complications like diabetic feet, your stem
Follow-up
cells will be injected directly into the damaged area.
Once you have returned home, a member of our medical Multiple injections will be given in order to improve vasu-
team will regularly monitor your progress via telephone larization.
and email. For your convenience, a telephone 'hotline' is
always at your disposal. Possible Adverse Events from the treatment

Cost Slight pain at injection sites.

The total price for angiography treatment is 8.925 Euros.

XCell-Center
 Treatment advantages This price does not include travel expenses such as
airfares and meals, or accommodation costs. Contact:
Simple
XCell-Center
Out patient General the Institute for Regenerative Medicine
Low overall risk c/o Eduardus-Krankenhaus
No additional charges will be incurred unless you are Custodisstraße 3-17
Follow-up D-50679 Cologne
required to extend your stay at the medical center as a Germany
result of complications. Costs do not include additional
Once you have returned home, a member of our medical Phone: +49221 8025095
stem cell treatments. If another treatment is necessary,
team will regularly monitor your progress via telephone Fax: +49221 29212550
we will discuss potential options with you.
and email. For your convenience, a telephone 'hotline' is
E-mail: info@xcell-center.com
always at your disposal. Internet: www.xcell-center.com
You will receive an invoice one week prior to treatment.
Cost This invoice must be paid in-full before treatment can
begin.
The total price for the direct injection treatment is
6.545 Euros. Note: If your bone marrow sample is negative or the
This price includes: stem cells cannot be administered due to unforeseen
medical circumstances, you will only be required to pay
Bone marrow collection and transportation charges incurred to that point. In the case of a negative
Stem cell processing, storage and transportation bone marrow sample, it might be possible to schedule
Stem cell administration another bone marrow collection.
XCell-Center medical fees
XCell-Center administrative fees

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