Heart stem cell trials:



STEM CELL THERAPY PROVIDES
RELIEF FOR TRIAL PATIENTS WITH
UNTREATABLE CHEST PAIN
Patients with severe angina had stem
cells from their blood injected into their
heart.

The therapy, carried out by Chicago's
Northwestern University, halved the
number of bouts of angina chest pain.

The study, reported in the journal
Circulation Research in July 2011, was
carried out on 167 patients with
"refraction" angina, which does not
respond to any standard treatment.

They were given high or low dose stem
cell infusions, or a dummy injection.

A year on, patients in the low-dose
group had an average of 6.3 episodes
of pain a week, compared to 11 a week
for those given the placebo jab.

It translates as going from being able
to walk slowly to being able to ride a
bike.

The length of time they were able to
tolerate exercise also improved by 139
seconds after six months, compared to
an improvement of 69 seconds for the
placebo group.

The treatment used bone marrow stem
cells called CD34+ cells which circulate
in the blood.

Previous research has suggested
these cells can create new blood
vessels in diseased heart muscle.

The researchers used a growth-
stimulated drug to boost their numbers
before harvesting them.

The cells were then injected into areas
of heart muscle that had been starved
of blood.

The Chicago team plans to further
develop the technique in more
advanced Phase III trials later this year.



SMALL CEDAR-SINAI TRIAL IS
PROMISING
In March 2012 a small but very exciting
study conducted by the Cedars-Sinai
Heart Institute shows that for the first
time, heart-attack patients who
received an infusion of their own heart-
derived stem cells were able to regrow
healthy new heart muscle.

The CADUCEUS trial, published online
in the journal Lancet, involved 25
heart-attack patients who, one year
after their own stem-cell infusion,
showed a reduction in their heart-
attack scar size from 24 percent of
their heart mass to 12 percent.

This represents a potential paradigm
shift in our understanding of patients
who are post-heart attack. If this is
successful when repeated on a larger
study population, we may be able to
help patients to reverse the damage
caused by a heart attack and
"dissolve" the heart's scarring.






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.



TCA CELLULAR THERAPY INFUSES
ADULT STEM CELLS AFTER BYPASS
Heart Bypass Patients Improve
Significantly with Adult Stem Cell
Infusion Reports TCA Cellular Therapy.
Utilizing their proprietary combination
adult stem cell product derived from a
patient's own bone marrow, the
research team infused a combination
of cells directly into heart attack
patients' hearts during bypass surgery.
During the trial, seven patients
received the adult stem cell infusion,
and three control patients did not.
While other trials used a single cell
type, this is the first research in the
world using a combination of two
different types of stem cells during
bypass surgery.
"The conclusion of the study,"
explained TCA Cellular Therapy
president Gabriel Lasala, MD, "is that
the treatment is safe and better
improves heart function in patients who
received adult stem cells during
surgery, as opposed to those with only
surgical bypass."
During the follow up period, the first
two months of improvement are the
results of the surgery. After month 2
the improvements are attributed to the
adult stem cells injected. These
changes were observed in the
increase in blood flow as well as the
pumping action of the heart. The
theory that the combination cell
product may promote the development
of mature and stable capillaries will be
further examined in the Phase II clinical
trials.

We should take note that TCA
multiplies (cultures) stem cells before
injecting them back into a patient. This
step is a crucial one. There are many
clinics all over the world that will
withdraw and isolate stem cells. Yet, if
these cells aren’t in a high
concentration, it seems unlikely that
you’ll get an effective dose. TCA
spends 3 weeks or so culturing a
patient’s cells until they have 30-40
million mesenchymal (multipotent)
adult stem cells. This work is
performed at their in-house GMP lab
and stored at Life Source Cryobanks
(which TCA has a controlling interest
in). Again, these are signs that TCA
knows what it’s doing.




BIOHEART REPAIRS DAMAGED
HEARTS USING STEM CELLS
How do you mend a broken heart?
Many scientists say stem cells are the
answer, but they’re not sure how best
to use them and make money doing it.
Clinical trials by the University of Miami
and Sunrise-based Bioheart  are
among a wave of studies searching for
ways to repair damaged hearts using
stem cells. Numerous animal tests
have shown stem cells can transform
into new heart muscle to repair tears
after a heart attack or partially replace
scar tissue from old cardiac episodes.
UM is running four clinical trials that
inject stem cells from bone marrow into
damaged hearts. One uses a unique
catheter designed by BioCardia
instead of major surgery. Another
compares stem cells taken from
patients to donor stem cells.
As it works on finishing trials during
2010, UM is already looking at the next
source of stem cells. It is working on a
method to extract  stem cells from a
patient’s heart muscle, multiply them
and insert them back into the heart.
Hare said these stem cells might
convert into heart muscle more easily.

Bioheart has several promising trials
ongoing with stem cells.
Early-stage data from the company’s
clinical trial for MyoCell – a process
where muscle stem cells are taken
from patients’ legs and implanted in
damaged hearts – showed that
patients improved their walking
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.
Bioheart Chairman and CEO Karl E.
Groth said using TGI 1200, which the
company licensed from Tissue
Genesis, is one of the fastest
ways to treat a patient with their own
stem cells. The product is already
approved in the European Union,
where medical devices must
demonstrate safety, but not
effectiveness in treatment.

Bioheart's TGI 1200 Cell Isolation
system is a  compact, fully automated
cell isolation system for the rapid
processing of patient-derived adipose
(fat) tissue to separate, isolate and
produce large yields of endothelial
progenitor cell, mesenchymal stem
cells and other regenerative stem
cells. The fat tissue is extracted from
the patient using a minor liposuction-
like procedure and processed using
the TGI 1200. The TGI 1200 System
produces the regenerative stem cells
in about one hour.
Unlike MyoCell, which is intended to be
used to treat severe heart damage
months or even years after a heart
attack, Bioheart’s Acute Cell Therapy
is being designed to be used for the
treatment of muscle and blood vessel
damage immediately following a heart
attack. They hope to demonstrate that
the injection of endothelial progenitor,
mesenchymal stem cells and other
regenerative stem cells derived from
fat tissue by the TGI 1200 Cell
Isolation System is a safe and effective
means of limiting or reversing some of
the effects of a heart attack and
preventing or slowing a patient's
progression heart failure.
Bioheart is currently marketing these
systems outside the US in countries
recognizing the CE Mark approval.


SELECTED CLINICAL TRIALS
Sponsor, Cell type, Phase, Expected
enrollment:
Bioheart, Munich, Germany Skeletal
myoblasts II/III 390
Osiris Therapeutics, Columbia,
Maryland Mesenchymal stem cells II
220
Cedars-Sinai Medical Center, Los
Angeles, California
Cells from heart biopsies I 30
Ministry of Health, Brazil Bone-marrow
cells III 300
Johann Wolfgang Goethe University
Hospitals, Frankfurt, Germany
Bone-marrow cells III 200
Barts and The London NHS Trust, UK
Bone-marrow cells II/III 165
Seoul National University Hospital,
Korea Circulating blood cells II/III 116

OTHER DEVELOPMENTS
CYTORI
Bioheart has a competitor  in San
Diego-based Cytori. Its Celation
System also converts fat from
liposuction into stem cells. The
company currently has two clinical
trials with stem cells in heart patients.



ANGIOBLAST
New York-based Angioblast looks to
bypass intellectual property issues by
developing its stem cell-based cardiac
treatment like a drug. It isolated and
purified what it considers the ideal
donor stem cell and has mass-
produced it for injection into damaged
hearts.
Angioblast VP of Operations Michael
Schuster said early results from two
clinical trials are encouraging. He
believes it will prove more
consistent than patient stem cells,
which could be weak when derived
from sick or elderly patients.




BRISTOL UNIVERSITY
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,