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BACKGROUND 03
The utilization of insulin in the conventional treatment of diabetes
mellitus – for both the dysfunctional secretion of insulin and insulin Who should consider adult
production with the objective of normalizing blood glucose levels stem cell therapy?
is still common practice. However, this is a symptomatic approach
How adult stem cells are
and curing diabetes involves a great deal more. supposed to function
CASE REPORT 04
successes of stem cell therapy, which is
evident in the two classic types of diabetes Case report
mellitus. Patient interview
RESEARCH NEWS 06
Cologne-based XCell-Center, at the In-
stitute for Regenerative Medicine in Successes in the treatment of
Eduardus Hospital, practises diabetes type 1 and 2 diabetes mellitus
patients
therapy with adult autogenetic stem cells
using a method that has been officially
XCell-Center starts SCIDIM 1
certified by the competent government and 2
authorities. The first step of the treatment
involves checking the patient’s therapy DISCUSSION FORUM 08
>> Continued from page 1 e. g. the diabetic foot, stem cells can be
Blood plasma, erythrocytes, leukocytes locally injected into the damaged area.
and stem cells are isolated in a clean room This may, among other things, foster the
environment. The stem cells undergo healing of ulcers. The entire procedure,
quantitative and qualitative testing. Using i. e. from stem cell biopsy to re-injection
a special method of centrifugation, the of the prepared stem cells normally takes
stem cells are concentrated so that about 3 to 4 days. The patient can be discharged
one tenth of the originally harvested from the clinic within a few hours of
marrow contains 90 % of the stem cells. bone marrow collection and stem cell re-
During processing, the results are analyzed injection.
and recorded in a report; the outcome is
considered positive if more than 2 mil- The success rate of the diabetes treat-
lion stem cells (CD34+) remain and have ment with stem cells at the XCell-Center
a survival capacity of more than 80%. is reassuring. A decrease in the daily dose
of insulin required within three months
If the result is positive, the isolated stem of treatment is observed in the majority
cells are stored under sterile conditions of patients – ideally, they can completely
at –196°C in liquid nitrogen. The XCell- forego the use of insulin. The significant
Center has patented its method of stem success rates and the low risk are both
cell preparation. The product also refer- good reasons for considering treatment
red to as ”stem cell concentrate“ is con- with adult stem cells. by the body and all other risks are no
sidered to be a drug pursuant to German higher than the risks associated with any
law and is therefore subject to the strict Given that the prepared stem cells are intervention performed under hygienic
provisions of the German Pharmaceuticals autogenetic tissue, they are not rejected conditions. !
Act.
The bone marrow biopsy, its preparation Dr. med. Peter Nitsche is a physician special-
and reinjection are all compliant with Good izing in internal medicine and diabetes. He is
Manufacturing Practices (GMP), i. e. qua- an expert in providing adult stem cell therapy
lified and certified manufacturing pro- for diabetes mellitus at the XCell-Center’s In-
cesses. stitute for Regenerative Medicine.
During the further course of treatment, Before joining the X-Cell Center team, Nitsche
a pancreas MRT is routinely generated. practiced at hospitals in Herford, Bad Hersfeld
A catheter is pushed from the femoral and Kassel as a senior physician for several years.
artery into the pancreas artery under an- For the past 12 years, he has been a partner in
giographic monitoring. Then the prepared a medical group specializing in the treatment of
stem cells are implanted into the pancreas the diabetic foot in Münster. !
tissue. To treat complications of diabetes,
02 _ Issue 01 | 2007
E X P E R T I N F O R M AT I O N O N A P P L I E D R E G E N E R AT I V E M E D I C I N E
BACKGROUND
Stem cell therapy is an option for any diabetes patient and kidney failure are currently also excluded from the
whose condition will not improve as a result of lifestyle stem cell therapy. !
changes. It is most suitable for patients who do not
respond positively to standard therapies and whose
blood glucose levels can only be adjusted marginally
despite all efforts made. Patients suffering from diabe-
tes-related complications, such as diabetic foot, will also
benefit from the treatment with endogenous stem cells.
Issue 01 | 2007_ 03
ReMed
CASE REPORT
Case report
In 2002, Sven Fisher*, who was 34 years area as a result of the catheter insertion day and cut down the short-term meal-
old at the time, was diagnosed with type and pressure in the abdomen caused by accompanying insulin to only half of the
1 diabetes. He was initially treated with the cortisone – disappeared completely original dose.
Levemir (2x9 IE/day) and Novo-Rapid
® ®
within three weeks of the procedure.
(a total of approx. 20 IE per day). Although The discomfort in his arms and legs had Three months after the transplant, Sven
the patient monitored his blood glucose also improved by this time, and he was Fisher was able to go out for extended
levels very diligently, he began to develop able to start moderate jogging four weeks runs that even included short and long
increasing symptoms of poly-neuropathy after the treatment. sprints. Today, about four months later,
in his arms and legs over time, which he does not need any long-term insulin
manifested as tingling in the extremities, From the fifth week onwards, his arm and and is able to maintain a relatively stable
numbness and weakness. The patient leg problems had disappeared almost blood glucose level of 85-110 mg/dl using
also observed a considerable loss of con- completely and the patient noticed that 5-9 IE NovoRapid® on a daily basis. !
centrative powers. Sven F., who had his concentrative powers were beginning
been an active athlete until the onset of to improve, while his need for insulin
diabetes, felt that the disease was having dropped. He was able to reduce the
a serious adverse impact on his quality of dose of long-term insulin to 2x5 IE per *name changed
20
insulin requirement [IU/day]
20 18
The stem cells were transplanted in
May 2007. With the support of an 15
(Prednisolon) for the first few days after Start of therapy After 5 weeks After 16 weeks
04 _ Issue 01 | 2007
E X P E R T I N F O R M AT I O N O N A P P L I E D R E G E N E R AT I V E M E D I C I N E
Interview with
Sven Fisher
You have been suffering from type 1 diabetes therapy, which is why I first wanted to try
for the past five years. What motivated you to it out. I assumed that – apart from the
seek out other treatment options? normal risks of any surgical intervention –
I was devastated when I started to have I wouldn't have to deal with any serious
problems so soon after beginning insulin side effects.
therapy. My feet and hands tingled a lot
and felt numb. It got so bad that I could How did the XCell-Center inspire hope in you?
hardly do any sports. I didn't want to live They were very cautious about making
with these kinds of restrictions perma- promises. Up to now, the XCell-Center
nently, especially since I'm a passionate has gained most of its experience from
jogger. My doctor told me I could try the treatment of type 2 diabetes. I was levels are still in the normal range. When
blood circulation stimulating medi- one of the first type 1 diabetics willing to I eat a meal, I still take insulin, but I'm
cation, but that other than that I had try this therapy. There was justified hope needing less and less of it.
no further options. that the treatment would be successful,
but no verified data. The XCell-Center How did your diabetologist react?
What did you decide to do next? told me these facts quite bluntly. He is very interested in the treatment
I didn't want to give up, so I started to since he had never heard of this therapy
search hard for other treatment options. How time-consuming was the treatment? Did before. He is now monitoring my treat-
For instance, I got information about you have to go to the XCell-Center a lot? ment intensively.
organ and island cell transplants. But Actually, the treatment proved not to be
both of these options would have meant time-consuming at all. I only had to go in How do you rate the therapy from today's per-
me having to swallow pills for the rest of twice: the first time for the bone marrow spective?
my life to suppress my body's rejection biopsy and the second time to have the Obviously, it would be absolutely great if
of the transplants. It was by pure chance concentrated stem cells injected. the treatment resulted in me not having
that I saw a television report on the to take insulin at all. On the other hand,
XCell-Center. I checked out the clinic on When did you first feel that the transplant had I am very satisfied as things stand – as my
the internet and the information that I been successful? quality of life has improved significantly
found made me very optimistic that About three weeks afterwards my feet since I had the treatment. Now that
maybe something could be done for me felt completely normal – the numbness I don't need to take long-term insulin
after all. was gone. It took a while longer for me to any more, I can do sport whenever I feel
realize that I needed less insulin. Initially, like it without having to worry about
Why did you opt for the treatment with I was able to reduce the dose of long- possible diabetes-related problems. I can
autologous adult stem cells? term insulin by half and finally I could basically do most of the things I’ve
Rejection isn't an issue with this new stop taking it completely. My glucose always enjoyed. !
Issue 01 | 2007_ 05
ReMed
RESEARCH NEWS
Initial results lead to the conclusion that synthesis of insulin significantly improved The chart on page 7 shows the successes
therapy with adult stem cells can yield and remained at a constant high level, of a recently completed post-authori-
lasting effects. Voltarelli et al. demons- which indicates a sustainable effect of zation trial involving type 2 diabetics.
trated in a small group of young patients stem cell therapy (Voltarelli, 2007). Oral insulin and anti-diabetic medication
suffering from type 1 diabetes that the requirements declined in all 25 subjects
combination of immune suppression and after the transplantation of adult stem
the application of haematopoietic stem cells. Approx. 25 % of the patients did
cells led to long-term insulin indepen- not need insulin after one treatment.
dence in 14 of 15 patients. The therapy Over the course of the trial significant
allowed one patient to give up insulin progress was evident in relevant diabe-
completely for more than 35 months and tes parameters. The fasting glucose in
four other patients did not need insulin the plasma sank along with the con-
injections for at least 21 months. Seven centration of glycosides haemoglobin
patients remained insulin independent (HbA1c), which dropped by a signifi-
for six months and the other two patients cant amount. The C-peptide level in-
were insulin independent for between creased, indicating a cumulative insulin
one and five months. The endogenous synthesis. !
06 _ Issue 01 | 2007
E X P E R T I N F O R M AT I O N O N A P P L I E D R E G E N E R AT I V E M E D I C I N E
ng/ml
2
100 4
1
50 2
C-peptide
0 Fasting glucose level 0 HbA1c (glucose memory) 0 (biomarker for insulin synthesis)
Note: 1 Own data; 2 Li Chen a.o., ”Autologous Transplantation of Bone Marrow Monoudear Cells in Treating Patients with Diabetes“;
3 Voltarelli a.o., ”Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Mellitus“, 297 (14): 1568, 2007 JAMA.
Issue 01 | 2007_ 07
ReMed EXPERT INFORMATION ON APPLIED REGENERATIVE MEDICINE
DISCUSSION FORUM
Stem cell therapy is a polarized topic of public debate. Is it progressive treatment that has the potential to cure
many diseases or are stem cells something from the dark side of genetic experimentation alongside cloning – a
sadistic method that requires the killing of embryos? The world is plagued by quacks who peddle stem cell mirac-
le cures and scientists who falsify trial results on a grand scale and bring the scientific community into disrepute.
One of the issues preventing public en- cesses. Initial individual case reports of hazardous treatment with adult stem cells
lightenment is the fact that stem cells are patients suffering from spinal injuries, and puts medical professionals in a posi-
still a topic of controversial debate even multiple sclerosis, Parkinson's and Alzhei- tion to assume responsibility for its use.
among many medical expert groups. The mer's disease show that an attempt at
medical fraternity, which strives to give therapy may yield beneficial results. Given the proven treatment success of
its patients competent advice, is being regenerative medicine, the question of
confronted with a question of principle: To do the one thing does not mean not whether more research is needed prior to
is stem cell therapy ready for practical doing something else. Consequently, the therapeutic use has already been answer-
applications or will it take another ten to XCell-Center does perform accompanying ed. Those who nevertheless demand stem
twenty years of research? trials that examine the effectiveness of cell therapy be postponed until we know
stem cell therapies and will complete our more about it are taking away patients’
The XCell-Center/Institute for Regenera- understanding of the exact regenerative rights to make their own decisions as they
tive Medicine in Cologne answers this processes in the affected organs. Even if search for medical solutions – for the kind
question with facts. Since January, it has not all of the interactions have been con- of help stem cell therapy does offer.
been treating primarily diabetes and stroke clusively researched to date, the status of
patients with autogenuous adult stem the current medical insights has indeed Dr. Kleinbloesem is the Managing Director
cells and has achieved remarkable suc- reached a level that allows the non- of the XCell-Center.
LEGAL INFORMATION
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