Stem Cells Treatment:


FIRST US PATIENT GETS  STEM
CELL TRACHEA TRANSPLANT IN
EUROPE
In June 2011 Christopher Lyles, 30, of
Abingdon, Md, exhausted the limited
treatment options available in the U.S.
for his tracheal cancer. But Lyles read
about an experimental tracheal
transplant procedure surgeons
performed in Europe using adult stem
cells.

Lyles reached out to Dr. Paolo
Macchiarini, director of the Advanced
Center for Translational Regenerative
Medicine at the Karolinska Institute in
Stockholm, who was the head surgeon
in previous transplant cases.

After a 12 hour procedure in Sweden,
Lyles was breathing through a lab
grown windpipe that doctors fashioned
from his own stem cells.

Doctors regenerated tissue from Lyles'
bone marrow stem cells to create a
trachea biologically identical to Lyles'
original organ. Lyle underwent the
transplant in November 2011.

Within three months, Lyles was able to
eat and speak on his own.

Once the trachea is damaged, it is
difficult to get it to heal correctly.

Trachea cancer is resistant to
chemotherapy and radiation and
attempts to replace the trachea with
mechanical devices have not been
effective.

Lyles first underwent seven rounds of
chemotherapy and 33 rounds of
radiation treatment between July and
September.

Using a patient's own stem cells not
only could help to rebuild the fragile
tissue, but also potentially could
bypass the risk of having the organ
rejected.






HOW THE STEM CELL RACE STANDS
AT THE END OF 2011
Regarding stem cell treatments, for
years,  there was a lot of hype around
the industry  and the industry failed to
live up to that hype.

In November 2011 US biotech
company Geron announced that it is
leaving the field of stem cell research.


On the other hand stem cell therapy is
gaining credibility elsewhere as  real
clinical data begins to emerge.

The promise of stem cells lies in their
ability to repair tissue, reduce
inflammation, regulate the immune
system, and respond to calls for help
from multiple places inside the body.
Stem cells are the body's master cells -
blank slates that renew themselves
and mature into specific cell types in
the heart, muscle and other organs.

Aastrom Biosciences Inc recently
presented promising results from a mid-
stage trial of its treatment for patients
with critical limb ischemia, a disease in
which blood flow to the extremities is
restricted, at the American Heart
Association's annual meeting.

A mid-stage trial from Australia's
Mesoblast Ltd showed its stem cell
product reduced the rate of heart
attacks and the need for artery
clearing procedures by 78 percent.

Mesoblast has attracted more interest
from investors than most. In late 2010,
Cephalon Inc took a 20 percent stake
in the company, which now has a
market value of $2 billion -- far greater
than any other pure play company in
the space. Cephalon was bought this
year by Teva Pharmaceutical
Industries Ltd..

Shire Plc said in May 2011 that it
planned to establish a new
regenerative medicine business, and
kick-started it with the $750 million
purchase of Advanced BioHealing Inc,
which makes a skin substitute for
treating diabetic foot ulcers.

Amorcyte is intent on developing
patients' own enriched bone-marrow
stem cells as a treatment for
cardiovascular disease. The idea is to
infuse the stem cells into the heart a
week or so after a severe heart attack,
where they will linger and help restore
damaged tissue.
In December 2010 the company
reported results   of a clinical trial
evaluating Amorcyte, Inc.'s lead
product candidate, AMR–001 for the
treatment of damaged heart muscle
following acute myocardial infarction
(AMI). Data demonstrated a significant
relationship between cell dose and
biologic effect. This is the first and only
study to prospectively define a dose of
a purified and potent autologous (self-
donating) stem cell therapy that
resulted in a significant improvement in
perfusion, a trend towards improved
cardiac function and the potential to
reduce subsequent adverse cardiac
events following AMI.


There are going to be dividing lines in
the industry between autologous and
allogeneic and there are some
indications where one will be better
than the other.


Some companies, such as Celgene
Corp, Pluristem Therapeutics Inc,
Athersys and Mesoblast are
developing so-called allogeneic
products designed to be sold with the
ease and scale of a traditional
pharmaceutical. Cells are taken from a
single donor, expanded, frozen and
shipped for use in thousands of people.

Aastrom, Baxter, NeoStem and Cytori
Therapeutics Inc use cells taken from
a patient's own body in what is known
as an autologous transfer. This
personalized approach eliminates the
risk that the cells will be rejected.

Different types of stem cell are being
used for different diseases. Cytori is
developing a heart disease product
derived from fat cells, for example,
while Celgene is using placental cells
for Crohn's disease and rheumatoid
arthritis therapies.

Fetal cells are also being explored.
Neuralstem Inc, for example, is
developing treatments for neurological
disorders from an aborted fetus and is
in the early stages of testing a
treatment for amyotrophic lateral
sclerosis, known also as Lou Gehrig's
disease.

Companies with credible partners will
likely have an advantage. Athersys
has a partnership with Pfizer; Cytori
has a partnership with General Electric
Co; Pluristem has a partnership with
United Therapeutics Corp. Celgene,
which makes cancer drug Revlimid,
has resources of its own.





AASTROM SHOWS GOOD RESULTS
IN PHASE 2 TRIAL
In September 2011, in a phase 2 study,
a personalized cellular therapy
developed by Aastrom Biosciences
significantly restored damaged tissue
in the legs of patients with arteries that
are severely blocked.

Aastrom will soon begin a phase 3
study to determine whether the cellular
therapy, which is custom grown for
patients from their own bone-marrow
stem cells, can reduce amputations
and prolong survival in patients with
severe cases of critical limb ischemia
(CLI).

Patients with chronic CLI have
obstructed arteries and reduced blood
flow in the arms and legs, which can
lead to open wounds and amputation
in the most severe cases. CLI affects
about 1 million people in the U.S. each
year and leads to about 160,000 limb
amputations each year.

In the mid-stage study, 72 patients with
CLI were treated with a one-time series
of 20 injections in the legs and foot
containing either Aastrom's cellular
therapy, known as ixmyelocel-T, or a
sham control.


ATHERSYS  VS MESOBLAST
These are two small but very promising
companies in the stem cell field.

Cleveland, Ohio based Athersys
technology is based upon the
Multipotent Adult Progenitor Cell
(MAPC) discovered by Dr. Catherine
Verfaillie and her colleagues at the
University of Minnesota.

The Australian company Mesoblast's
technology is built upon the discovery
of adult-derived Mesenchymal
Precursor Cells (MPCs).

Both progenitor cells and precursor
cells are typically derived from human
bone marrow and do not have any of
the moral issues associated with
embryonic stem cells. As this is an
emerging science, the reality is that it
is impossible to determine which, if
any, cell is superior or will be more
effective in clinical trials.

According to the Athersys website,
progenitor cells have distinct
advantages.

One advantage Athersys points out:

…cells can be produced in significant
quantities, thereby enabling scaled
and reliable production. This enables
Athersys and its collaborators to
produce a standardized, well  
characterized therapeutic product in a
reliable and cost effective manner.
Athersys has established cultures and
carried cells through sufficient
passages to represent potentially
hundreds of thousands of potential
doses from an individual donor.

The Mesoblast website discusses the
distinct advantages of precursor cells:

Mesoblast aims to generate a series of
high margin, off-the-shelf adult stem
cell products that are obtained from a
single donor, commercially expanded
and frozen, and subsequently used in
potentially thousands of unrelated, or
allogeneic , recipients at the time and
place of need.

A potential $111,000,000 partnership
deal Athersys signed with Pfizer  in
December 2009.

The Athersys/Pfizer transaction is
specific only to the use of MultiStem for
Inflammatory Bowel Disease and
nothing more.

Mesoblast has made a deal with
Cephalon which  gave Mesoblast the
potential to earn up to $1,700,000,000
in milestone payments.

The Mesoblast deal with Cephalon is
wide ranging, covering cardiovascular
and central nervous systems, including
congestive heart failure, acute
myocardial infarction, stroke,
Parkinson's disease and Alzheimer's
disease.






STEM CELL THERAPY SHRINKS
ENLARGED HEARTS
Doctors at the University of Miami are
working on ways to treat heart failure
patients using their own stem cells.
And the results are promising.

A study of eight patients has now been
published. All had their hearts injected
with their own stem cells and all had
positive results. Heart size decreased
15 to 20 percent. Scar tissue
decreased 18 percent. And there was
dramatic improvement in heart function.

This is good news for people with
enlarged heart. As per a study
conducted by researchers of the
University Of Miami Miller School Of
Medicine, stem cell inserted in the
infected area of heart can cure many
heart ailments.
Citing the positive results of stem cell
therapy, the team claimed that all
those people who have been
struggling with the effects of enlarged
hearts like frequent hospitalization,
disability and even death can now
access this therapy under medical
supervision.
For the study, the team used a
corkscrew-shaped catheter to insert
stem cells on eight men of the age of
57 years, who were struggling with the
effect of poor functioning heart.

There are two types of bone marrow
stem cells, mononuclear or
mesenchymal stem cells. The team
claimed that both the stem cells proved
to be great help for the study.
After monitoring the condition for a full
year, the team observed that abnormal
size of the heart was reduced by 15 to
20%. Moreover, the ugly scars
decreased by about 18.8% and
further, a significant improvement in
the functioning of heart was observed.
The team claimed that most of the
patients have reported positive results
from the therapy and no potential side
effects were observed in them.





STEM CELLS FROM BELLY FAT MAY
BE A TREATMENT FOR HEART
ATTACK
Stem cells taken from the belly fat of
10 heart attack patients managed to
improve several measures of heart
function, Dutch researchers report at
the   Thoraxcenter, Erasmus University
Medical Center in Rotterdam..

Fat tissue yields many more stem cells
than bone marrow  and is much easier
to access.

In bone marrow, 40 cubic centimeters
(cc) typically yield about 25,000 stem
cells, which is not nearly enough to
treat people with. To get enough cells
to work with, those stem cells would
have to be cultured, a process that
can take six to eight weeks.

By contrast, 100 cc's of fat tissue yield
millions of stem cells, plenty to work
with. A hundred cc's is about the size
of a coffee cup -- a European coffee
cup, not the mega-size of American
coffee containers.

All patients in this double-blind,
placebo-controlled study (11 men and
three women) arrived at the hospital
having suffered a severe heart attack.
All then underwent cardiac
catheterization to assess blood flow,
followed by angioplasty, to restore
blood flow.

Within 24 hours of the heart attack,
doctors performed liposuction to
remove fat tissue, isolated 20 million
stem cells and gave them back to the
patients through a catheter. The
infusion took no more than 10 minutes.
Ten patients received stem cells and
four received a placebo infusion.

Six months after the procedure, stem
cell patients had better blood flow
(more than triple the rate compared to
patients getting a placebo), a 5.7
percent increase in heart pumping
ability, and a 50 percent reduction in
scarring of heart muscle (from 31.6
percent right after the heart attack to
15.4 percent). Placebo patients saw no
decrease in scarring.

The Dutch research team is now
embarking on a trial that will ultimately
enroll 375 heart attack patients at 35
medical centers in the European Union
to further test stem cell infusions.





STEM CELLS INJECTED INTO THE
BRAIN OF A STROKE PATIENT

Doctors in Scotland  have injected
stem cells into a man's brain as part of
the world's first clinical trial of the cells
in stroke patients.

The former truck driver, who is in his
60s, was severely disabled by a stroke
18 months ago and requires
continuous care from his wife.

Doctors injected around two million
cells into a healthy region of his brain
called the putamen, close to where
neurons were damaged by the stroke.
They hope the injected cells will
release chemicals that stimulate new
brain cells and blood vessels to grow,
while healing scar tissue and reducing
inflammation.

ReNeuron (UK) developed the
procedure. The trial is known as the
Pilot Investigation of Stem Cells in
Stroke (PISCES).




PLURISTEM STEM CELL THERAPY
WORKS WELL FOR PERIPHERAL
ARTERIAL DISEASE
Pluristem Therapeutics said early
clinical trials show its placenta-derived
cell therapy is safe and improves
quality of life in patients with peripheral
artery disease, or PAD.

The Phase I trials, conducted at three
university hospitals in the United
States and one in Berlin, show the
cells are effective in treating the end
stage of PAD, called critical limb
ischemia, the Israel-based biotech
company said.

Unlike many other companies that use
embryonic stem cells, Pluristem
harvests cells from the placenta after a
woman gives birth, so there is no
ethical issue on using embryos.

"We have proved we can use the
placenta as a source for a product that
doesn't require a match between the
donor and patient," Chief Executive
Zami Aberman said.
While an estimated 20 million people in
the United States suffer from PAD,
Pluristem is targeting the 2.5 million
who are in the end stage. Insurance
companies pay about $10 billion a
year to treat those patients.

Pluristem estimates it can slash
reimbursement costs of insurance
companies by about 50 percent, as the
cost of treating PAD using its therapy,
called PLX-PAD, is significantly
cheaper than current methods, which
run to around $40,000 per year.

Present treatment for PAD include a
bypass to improve circulation, drugs to
improve bloodstream and oxygen
chambers.

"These can stop progress of the
disease for a while but do not change
the situation," Aberman said.

Pluristem's clinical trials showed
patients experienced improvement in
bloodstream, pain and quality of life for
six months following a 20-minute
session of injections.




WINDPIPE TRANSPLANTS USING
STEM CELLS
Ciaran Finn-Lynch, 11, underwent the
pioneering trachea transplant in March
and is set to return home to Northern
Ireland after the surgery was declared
a success.

Doctors at Great Ormond Street
Hospital in London took stem cells from
the youngster's bone marrow and
injected them into a donor windpipe
which had been stripped of its own
cells.
They implanted the organ and allowed
the stem cells to transform themselves
in his own body. By using his cells,
doctors could avoid the potential
problem of Ciaran's immune system
rejecting the organ.


MORE  WINDPIPE TRANSPLANTS
USING STEM CELLS
Medics created a windpipe transplant
with a British teenager's own stem
cells. This meant the teenager won't
need to take anti-rejection drugs

Doctors have carried out pioneering
lifesaving surgery to give a new
windpipe to a British teenager suffering
from cancer.
The 19-year-old was able to speak
within a few days of the operation
carried out in Italy using her own stem
cells.
Another 31-year-old patient from
Czechoslovakia also underwent
surgery for the same rare form of
trachea cancer.

Dr Walter Giovannini, from AOU
Careggi Hospital, in Florence, Italy,  
"This is a unique solution for a problem
that had none, except the death of the
patient."
'While trachea cancer is rare, it is very
difficult to treat because it is resistant
to chemotherapy and radiation and
transplants of mechanical devices to
replace the windpipe have not been
effective.'
The surgical team was headed by
Professor Paolo Macchiarini who
participated in a windpipe transplant in
Spain nearly two years ago.

A similar procedure was followed in this
case. The donor windpipe was stripped
of all cells until it was just a tube with
no organic material. Just before being
transplanted, Dr. Macchiarini injected
the donor trachea with the stem cells.
In the Spanish case, the stem cells
were grown on the trachea before the
transplant.

It takes two to three months for the
stem cells to completely cover the
trachea, creating a new organ.
The new approach is to install
the windpipe  immediately without the
cells, and waiting for the stem cells
turn it into an organ while being used.

The 31-year-old Czech and 19-year-
old British patients are in good
condition and have been released
from the hospital in Florence just
weeks after the surgery.

Macchiarini told a press conference in
Florence the procedure could in the
future be applied to other organs.
"I'm thinking about the larynx or
surgeries involving lungs."



BIOHEART  TESTING STEM CELLS IN
CONGESTIVE HEART FAILURE
In September 2011 Bioheart Inc, a
Florida company,  shares were rising
after they announced they will begin a
US clinical program called the ANGEL
trial utilizing adipose derived cells or
LipiCell for congestive heart failure
patients.

Using the clinical data from a Phase I/II
trial in Mexico and preclinical studies,
Bioheart will apply to the FDA to begin
a Phase I study in the US. In
collaboration with the Regenerative
Medicine Institute of Tijuana, Mexico,
six congestive heart failure patients
have been successfully treated in a
Phase I/II trial at Hospital Angeles
Tijuana.

The therapy involves the use of stem
cells derived from the patient's own fat
(adipose tissue) obtained using
liposuction. These patients have
demonstrated on average, an absolute
improvement of 13 percentage points
in ejection fraction and an increase of
100 meters in their 6 minute walk
distance.

After patient biopsies were shipped to
Bioheart laboratories, the ASMs
(autologous skeletal myoblasts)  were
isolated, purified, expanded and
returned to the physician for injection
back into the patient.

During a six-month observation period,
the patients who were treated with their
own ASMs were found to have
increased their walking distance by 91
meters during a six-minute period of
exercise, whereas those patients in the
control group who were treated only
with a placebo were found to have
decreased their walking distance by 4
meters.This may suggest that patients
with heart failure could return to a
more active lifestyle after receiving
Bioheart's treatment.



STEM CELLS HELP TREATING BURN-
INJURED EYES
Italian scientists report that they have
restored sight to patients blinded by
chemical burns using the patient's own
adult stem cells. The team treated 112
patients blinded in one or both eyes;
some of whom had been blind for
years. Adult stem cells were taken from
the edge of a patient's eye and
cultured on fibrin, then the cell layers
transplanted onto the damaged eyes.
The adult stem cells produced healthy
corneas and functioning eyes. Some
patients regained sight within two
months, while for others with deeper
injuries the process took a year before
vision was restored.
Patients were followed up to ten years
after the transplant. After a single
transplant, 69% of patients regained
vision; in some cases a second
transplant occurred, with a total
success in 77% of patients and partial
vision restoration in 13% of patients.
The long-term restoration was an
especially encouraging success of the
study.
Lead researcher Dr. Graziella
Pellegrini, of the University of Modena,
said:
"The patients, they are happy, even
the partial successes. We have a
couple of patients who were blind in
both eyes. Can you imagine for these
patients the change in their quality of
life?"
According to the scientists, the key to
success was insuring a high enough
concentration of adult stem cells in the
graft, so that the stem cells could
continue to generate new tissue. The
team reported their findings at the
annual meeting of the International
Society for Stem Cell Research.




GROWING NEW DISC WITH STEM
CELLS  BY MESOBLAST
The treatment, developed by the
Australian regenerative medicine
company Mesoblast, is  designed to
regrow the disc, using adult stem cells.

Patients with severe lower back pain
and potential candidates for back
surgery will be selected. Doctors will
inject adult stem cells, grown in lab,
into patent's damaged disc under local
anesthesia.




GROWING BONES  WITH STEM
CELLS
Italian doctors report that they have
used adult stem cells to regenerate
bone lost through severe gum disease
in patients. Dr. Marco Baldoni and his
team at the University of Milan treated  
patients with periodontitis experiencing
receeding gums and the destruction of
gum and bone tissue.
In a ten-year study, the Italian
researchers found that lost bone could
be regenerated using adult stem cells.
Patients had some of their bone
marrow adult stem cells removed and
cultured on a special collagen protein
support, then the cells were injected
into affected bone. Within a few
months, the adult stem cells had
entirely regenerated the bone lost
through disease. So far, the procedure
has been used for seven patients, in
every case successfully.
According to Dr. Baldoni:
"In fact, the preliminary results indicate
that the level of bone regeneration is
even greater than those obtained with
traditional methods."
Adult stem cells certainly give you
something to chew on. Regrowth of jaw
bone is just the most recent example of
using adult stem cells for patients to
stimulate hip bone growth and to repair
non-healing bones.




REGENEXX TREATMENT FOR  
OSTEOARTHRITIS AND BROKEN
BONES
Dr. Christopher Centeno, a pioneer in
stem cell research in Broomfield,
Colorado is now treating patients with
osteoarthritis, joint pain, knee injuries
and non-healing broken bones at his
clinic using the patient's own Adult
Stem Cells to repair the damage.

For Hal, an avid golfer, his quality of
life had deteriorated. Hal said,"Golf
was done in a cart with a handicap flag
on the cart with a cane hanging from
my golf bag."

Facing an ankle fusion as a fifth
surgery, Hal decided to change things
up and try to heal himself using his
own Adult Stem Cells implanted by Dr.
Centeno.

2 months after having his own stem
cells implanted, he didn't have to use
his cane anymore. Later, after 2 more
injections of his own Adult Stem Cells,
Hal was running again, "I got on my
treadmill and did my first mile where a
year before that, 100 yards was a job,"

From the stem cell article: For now, the
Regnexx treatment is strictly used on
some orthopedic patients, from
osteoarthritis sufferers, to knee
replacement candidates. Dr. Centeno
said soon, adult stem cell treatment
could replace orthopedic surgery
altogether.

The Regenexx Procedure is a
breakthrough, non-surgical treatment
option for people suffering from
moderate to severe joint or bone pain
due to injury and other conditions.




OTHER DEVELOPMENTS

Plerixafor by Genzyme to facilitate
stem cell collection from the bone
marrow;

Cytori Therapeutics is in clinical trials
using stem cells from fat in humans to
treat heart disease, liver failure,  and
in plastic surgery;



Tß4 Key Molecule capable of
triggering stem cells to repair damaged
adult heart by Regenerx Biopharma;

ViaCyte, Inc (formerly NovoCell) of San
Diego is making progress in using
stem cells to treat diabetes.

Using leftover blood vessels: Scientists
at Bristol University (UK) used blood
vessels left over from bypass
operations to produce the stem cells.
Surgeons during bypass surgery
always cut out a longer piece of vein
than they need, so there is always a
leftover piece.



STEM CELL GLUE TO REPAIR
BROKEN BONES
First they remove stem  cells from the
bone marrow of  the patient's hip.
These are mixed with a new collagen
gel called Cartifill to make a paste,
which is then smeared into the
fractures. They finally fix the leg in a
metal cage to gently  squeeze the
bones together.