rexresearch
Dr. Kristin COMELLA, et al.
Adult
Stem Cell Therapy
https://www.bibliotecapleyades.net/ciencia3/ciencia_industryhealthiermedica318.htm
http://healthimpactnews.com/
March 12, 2019
Adult
Stem Cell Therapy...
by Paul
Fassa
There have been nearly 12,000 adult stem cell therapies
performed in the United States with an over 90 percent success
healing rate for mostly joint and spinal conditions.
It involves using the patient's own stem cells, so no
patent-able drugs are involved.
They are targeting the most influential stem cell scientist in
the U.S., Dr. Kristin Comella in Florida.
Differentiating
the Types of Stem Cell Therapy
Many consider stem cell therapy 'the future of medicine'...
A stem cell can rebuild or create new cells in tissues, even in
organ tissues other than those from which they had originally
existed.
They could be considered seeds for growing body tissues. They
are mostly able to function for cellular repair and growth no
matter what organ is in need of repair or healing from chronic
inflammation.
There is a considerable controversy surrounding stem cell
therapy research, a branch of regenerative medicine. Much of the
controversy has to do with not differentiating between adult
stem cell therapy and embryonic stem cell therapy.
Embryonic stem cell therapy is the controversial one. It
cultures or creates stem cells from terminated or aborted
fetuses.
Currently, the FDA is harassing stem cell clinics that do not
derive their stem cell solutions from aborted fetus tissue. They
extract the stem cells from the patient's own adipose tissue and
inject them into areas where that same patient needs repair.
It's an autologous process called adult stem cell therapy.
U.S. Stem Cell based out of South Florida is one of the clinics
being targeted by the FDA, and the clinic's Chief Scientist is
Dr. Kristin Comella, PhD.
Many other nations have been using adult stem cell therapy
successfully over the past 15 years, leaving the USA dead last
in this field. The FDA is trying to make sure it stays that way
and allows costly pharmaceutical versions to prevail.
Dr. Kristin Comella and her clinic have been under attack from
the FDA.
This short 3-minute video was produced interviewing Dr. Comella
and some of her patients:
https://www.youtube.com/watch?v=PiCW4z7j0ww
U.S.
v. Dr. Kristin Comella
Examining
and Comparing the Different Types of Stem Cell Therapy
Human embryonic stem cell (hESC) therapy has received most of
the media's attention and government support.
But it is the most controversial because it involves extracting
tissues from terminated human embryos, aka aborted fetuses.
In addition to moral and ethical issues, human embryonic stem
cell (hESC) solutions create cells so rapidly where they're
injected they lead to cancerous tumors.
To avoid that, researchers have to use immuno-suppressant drugs
to curb the embryonic stem cells' tendency toward cancer.
Using pharmaceutical drugs to curb hESC cancer side effect
issues, leads to other unexplored and unexpected side effects
from those patented stem cell solutions.
But the profit motive for embryonic stem cell therapies was
strong and a lot of government funds had been put into its
research. Pharmaceutical companies were motivated because they
could patent stem cells created from embryonic tissues.
Bone marrow stem cell therapy was among the first to depart from
flawed hESC (human embryonic stem cell) therapies developed over
the past two decades. Bone marrow stem cell therapy was the
segue into the adult stem cell therapy movement.
Bone marrow extractions are painful, requiring general
anesthesia. It's relatively difficult and expensive compared to
adipose (fat) tissue stem cell harvesting.
Bone marrow's high white blood cell count also encourages
inflammation, making it counter-productive for patients already
suffering from chronic inflammation or autoimmune disorders.
Most importantly, adipose (fat) tissue yields up to 500 times
more mesenchymal stem cells than bone marrow sources, according
to Dr. Comella.
These are potent stem cells that can differentiate into a wide
variety of other cell types. Furthermore, the adipose white
blood cell count is lower than bone marrow matter.
Overactive, confused immune responses attack organs continually
and create chronic inflammation and autoimmune diseases.
The lower white blood cell count automatically lowers the risk
of further inflammation among patients already suffering from
chronic inflammation and autoimmune diseases.
The outpatient treatment involves creating a very small and
shallow incision that won't require stitches on an area of skin
covering adipose tissue (fat).
From there, liposuction can withdraw a portion of the fat. This
part of the procedure requires only a local anesthetic.
Then what is extracted is spun at high speed in a special
centrifuge to isolate the stem cells which are then purified for
IV drip delivery or injection into the same patient from whom it
was extracted.
Total costs range from five to ten thousand dollars or more in
some cases.
Dr. Comella and her colleagues' mission is to get adult stem
cell therapy available for everyone. Private and government
health insurance providers cover medical treatments that are
much more expensive.
Why not cover one that would save money with its lower expense
and fewer side effects?
Over the years, there have been nearly 12,000 adult stem cell
therapies performed in the United States with an over 90 percent
success healing rate for mostly joint and spinal conditions as
well as heart and lung issues.
But the three known adverse side effect cases continually get
all the media attention.
The Panama College of Cell Science, which helped launch Kristin
Comella's research and development, had this to say about her:
"Perhaps the most influential clinician on the subject of adult
stem cell therapy, Dr. Comella has been able to quietly develop
patient treatment protocols and treat patients via collaborating
physicians and health care providers using legal
patient-specific FDA guidelines, including studies permitted by
Institutional Review Boards, patient-specific stem cell clinical
trials, and direct treatments using the patients own stem cells
that are harvested and re-injected for therapeutic purposes.
"Through Dr. Comella's leadership, she and her team have trained
and certified more than 700 physicians worldwide in adult stem
cell therapy."
Big Pharma
is Using the FDA to Eliminate "Unregulated" Adult Stem Cell
Competition
Since the late 1990s, adult stem cells used therapeutically were
not under the control of the FDA and the adult stem cell
movement took off.
There were complaints from some MDs that the adult stem cell
practice should be regulated by the FDA.
The Panama College of Cell Science responded to those outcries
with this statement:
"The motive in opposing adult stem cell therapy is money.
"The big institutions want to keep federal funding of embryonic
stem cell research at a high level with the promise that cures
are "just around the corner" despite the fact that embryonic
stem cells will never be useful in any way for patient treatment
because they immediately cause tumors when transplanted."
Adult stem
cell therapy is an autologous treatment method.
The stem cells are not lab-created. They are only isolated and
purified after extracting them from the patient being treated.
Injecting them back into that patient powers up the body's own
healing mechanism to overcome chronic ailments.
The FDA didn't and shouldn't have anything to do with regulating
stem cells from one's own body. That situation has recently been
arbitrarily and suddenly changed.
Around 2014, the FDA started tweaking their guidance rules for
stem cell therapy with the purpose of getting new rules made
into laws through Congress that could be interpreted according
to FDA whims and enforced arbitrarily.
Their agenda is to consider adult stem cells as FDA-regulated
drugs.
During our phone conversation, Dr. Comella explained how the FDA
ignored testimonies from adult stem cell practitioners during
their 2015 public hearings regarding new guideline proposals.
Then they arranged to create new rules behind closed door
meetings that included pharmaceutical industry allies and
insiders.
The result was that by 2017, the FDA's hands-off policy with
adult stem cell therapy came to a sudden halt after years of
highly successful stem cell practice.
By 2018, the FDA got nastier with "the most influential
clinician on the subject of adult stem cell therapy" as its
target.
The FDA started doing inspections of Dr. Comella's South Florida
clinic that are designed for labs that manufacture drugs.
The standards for hospitals and clinics are not as strict as
drug manufacturers. Those inspections were inappropriate for a
clinic. But those inspections made it easier to create damaging
reports.
When the inspectors came by, they demanded to go into rooms
while treatments were taking place with semi-nude or nude
patients, which Dr. Comella prohibited.
The inspectors also demanded to view patient medical records.
She allowed that after redacting their names on the copies she
gave them.
For her actions to protect patients' privacy, inspectors
allegedly cited Dr. Comella for resisting and obstructing FDA
inspections.
Soon after the inspections, the FDA served Dr. Comella with a
lawsuit for practicing medicine with unapproved drugs. The
"drugs" were only those stem cell solutions drawn from patients
to be used on them.
The FDA has allegedly offered to drop the lawsuit if Dr. Comella
signed an agreement to stop doing adult stem cell therapy and no
longer promote it.
She refused. She said she has witnessed people leave their
wheelchairs for good from this therapy. The trial is set for a
Federal Court hearing beginning June 2019, in Miami, Florida.
If Dr. Comella loses this court case, adult stem cell therapy in
the USA may be forced out of the country and only be available
to those who can afford medical tourism...
Patents
STIMULATION
OF ANGIOGENESIS BY FIBROBLAST DERIVED EXOSOMES
WO2018195308
[ PDF ]
Disclosed are methods,
means, and compositions of matter useful for the stimulation of
angiogenesis directly by administration of membrane vesicles,
such as fibroblast-derived exosomes, and/or through induction of
angiogenic cytokines from blood cells contacted with
fibroblast-derived exosomes. The invention provides means of
treating conditions in which angiogenesis is beneficial through
local or systemic administration of exosomes, including those
derived from fibroblasts, wherein the fibroblasts are cultured
under basal conditions or conditions of hypoxia. In other
embodiments exosomes derived from fibroblasts are utilized to
augment endogenous regenerative processes, such as
hematopoiesis, angiogenesis and neurogenesis, as well as augment
regenerative processes stimulated by administration of exogenous
therapeutics such as cells, growth factors, or genes.
METHODS
OF ENHANCING FIBROBLAST THERAPEUTIC ACTIVITY
WO2018132594
[ PDF ]
Disclosed are
compositions of matter, cells, protocols and procedures useful
for augmentation of one or more therapeutic activities of
fibroblast cellular populations. In one embodiment fibroblasts
are pretreated with growth factor-comprising composition(s),
wherein the growth factor(s) may be cytokines, peptides, and/or
proteins. In another embodiment fibroblasts are cultured with
platelet rich plasma and/or derivatives from platelet rich
plasma. In another embodiment, fibroblasts are cultured under
hypoxic conditions prior to administration to an individual. The
disclosure further provides means of assessment of fibroblast
activity in vitro, including wound repair assay and cytokine
production, for example.
https://stemcellcollege.wordpress.com/2019/01/23/kristin-comella-phd-leading-the-way-to-adult-stem-cell-therapy/
Kristin
Comella PhD: Leading the Way to Adult Stem Cell Therapy
Dr. Kristin
Comella, PhD
This month we are highlighting the achievements of one of
our graduates, Kristin Comella, Ph.D.
Dr. Comella is a world-renowned expert on regenerative medicine
with a focus on adipose (fat) derived stem cells.
Terrapin, the organizer of the Annual World Stem Cells &
Regenerative Medicine Congress, commissioned a global survey of
the international stem cell community to create a who’s-who of
those significantly influencing the progress of the global stem
cell industry. She was named number 24 on Terrapin’s list
of the Top 50 Global Stem Cell Influencers. Dr. Comella was also
voted number 1 on the Academy of Regenerative Practices list of
Top 10 Stem Cell Innovators. Most recently, Dr. Comella made the
list of Top 50 Functional and Integrative Medical
Doctors/Scientists in the country by DrAxe.com, one of the most
visited natural health websites in the world. She has more than
a dozen peer-reviewed publications indexed on Pubmed in the
field of regenerative medicine.
[From: https://oneradionetwork.com/all-shows/dr-kristin-comella-biohacking-and-adult-stem-cell-therapy-great-look-at-using-our-own-stem-cells-naturally-and-giving-a-boost-january-8-2019/
]
Perhaps the most influential clinician on the subject of adult
stem cell therapy, Dr. Comella has been able to quietly develop
patient treatment protocols and treat patients via collaborating
physicians and health care providers using legal
patient-specific FDA guidelines, including studies permitted by
Institutional Review Boards, patient-specific stem cell clinical
trials, and direct treatments using the patients own stem cells
that are harvested and re-injected for therapeutic purposes.
Through Dr. Comella’s leadership, she and her team have trained
and certified more than 700 physicians worldwide in adult stem
cell therapy.
Patient therapy using the patient’s own stem cells (adult stem
cell therapy) is not favored in America and powerful forces in
the US government, namely the FDA, as well as in America’s big
and famous institutions and medical centers have opposed adult
stem cell therapy for 20 years. This includes certain of the
media, the scientific journals, Big Pharma, our country’s
leaders (FDA Directors always come from Big Pharma or aligned
medical institutions like Stanford, Harvard, UCLA, USC) and the
like even including the National Institutes of Health.
Which is why the US is last in the world.
The motive in opposing adult stem cell therapy seems to be that
the big institutions want to keep federal funding of embryonic
stem cell research at a high level with the promise that cures
are “just around the corner” despite the fact that embryonic
stem cells will never be useful in any way for patient treatment
because they immediately cause tumors when transplanted. But
many many big buildings have been built with government money to
research “stem cells”, yet seeming to study only their lab
created embryonic stem cell lines in the fervent hope that
someday Something will be patentable to the great benefit of
these same institutions. Use the government to fund everything
for free, then keep all the profits for themselves. Big
Pharma, the major pharmaceutical houses, do not seemingly want
to see advances in adult stem cell therapy either because that
means a reduction in their sales as patients use their own
repair stem cells to control many diseases rather than pills.
Plus, adult stem cells in your own body cannot be patented like
an embryonic stem cell can be. The idea of patient-specific
adult stem cell therapy using the patient’s own stem cells is
abhorrent to many people in power. The pharmaceutical houses
just haven’t caught on to the fact of the potential of
megaprofits available to them in supporting adult stem cell
therapy- the need for sterile kits, solutions, sterile growth
media, centrifugation equipment, counting and labelling kits,
not to mention what they could be marketing in the way of stem
cell activating factors, growth factors, individual expansion
units for physicians– it is a BIG market.
If the motive mentioned above cannot be proven in fact, it
certainly can be demonstrated by the result. There is no stem
cell therapy being generally used today in the United States
despite the fact that robust stem cell therapies are being
widely applied internationally to cure and control our most
debilitating diseases. There are fine centers in Europe
(Emcell, https://www.emcell.com/en/publications.htm), China
(Beijing Puhua International Hospital (BPIH),
http://puhuahospital.com/stem-cell-center/stem-cell-center ),
Thailand (Regeneration Center of Thailand,
https://stemcellthailand.org/treatments/ ), and Mexico where
many US physicians treat their patients. The finest stem cell
treatment center in the world is in Panama at the Stem Cell
Institute-Panama (https://www.cellmedicine.com/ ).
Why is the “finest center” not in the United States?
We are not unmindful of, and certainly, applaud the few
tiny steps being taken in the US by a handful of orthopedic
physicians using stem cell fractions in conjunction with some
orthopedic surgeries to enhance recovery and healing.
So it is understandable that against this backdrop, America’s
most gifted adult stem cell clinician, Kristin Comella, should
be singled out for attack, criticism, and personal smearing in
an effort to chill and silence her activities, if not outright
ban them. A federal lawsuit was even filed against her to stop
her treatment of patients and to slow the progress of adult stem
cell therapy. This lawsuit followed closely on the heels of her
blockbuster scientific report detailing the safety of adult stem
cell therapy in 676 patients…the FIRST paper of its kind in the
US. On peer review, this paper was not only passed without
objection but was earmarked for immediate fast track publication
in one of America’s most prestigious journals, the Journal of
Clinical Medical Research.
You can read the paper here: Safety Analysis of Autologous
Stem Cell Therapy in a Variety of Degenerative Diseases and
Injuries Using the Stromal Vascular Fraction
The Panama College of Cell Science is a foreign institution, a
division of Blue Marble University, registered in the
Commonwealth of Dominica. The College continues to offer the
ONLY doctoral program in stem cell biology in the world that can
be taken online. The College is directed by Walter P. Drake, a
published scientist with over 30 publications in bio-medical
peer-reviewed journals. While not accredited in the US, where
accreditation is not required whatsoever, the doctoral degrees
issued by the Panama College of Cell Science are nonetheless
equivalent to any doctoral degree issued by a regionally
accredited US college or university.
What does “equivalent” mean? It means that our program is the
SAME as any other program in terms of credits, and educational
requirements. This is determined not by us, but rather by
various foreign education evaluators. Every one of our graduates
who has sought a certificate of equivalency to use our PhD for
employment in the US or anywhere else has obtained such upon
graduation.
Our program has even been pre-approved by the California
University Foreign Credential Evaluation Service (CUFCE ) and
the Certificate of Equivalency is shown below. When we sought
review by CUFCE in 2011, the organization was on an
approved list of foreign credential evaluators published by the
United States Department of Education. The Department no longer
maintains such a list, but now refers students to seek out a
“professional foreign education evaluator” for such reviews.
Nearly every foreign education credential evaluation service
will find the same equivalency in our program.
Dr. Comella’s previous additional education includes a completed
doctoral program in Chemical Engineering at Ohio State
University where she passed her Comprehensive Examination for a
Ph.D. degree but left to pursue her own research prior to
completing her thesis. To better put her training into
perspective: Her graduate studies and course work at Ohio State
University provided her the opportunity to work with Dr. Jeffery
Chalmers to focus on the use of nano-particles magnets to
isolate/separate cells. She then delved more deeply into stem
cell research at Osiris Therapeutics — a small start-up in
Maryland — and was mentored within a company founded by the
‘father of Mesenchymal Stem Cells,’ Dr. Arnie Caplan. Following
her work at Osiris, Dr. Comella was offered the opportunity to
work with Dr. Darwin Prockop, the Grandfather of cellular
therapy research on mesenchymal progenitors, at Tulane
University.
We see an analogy in the similar attacks on Suzanne Somers. An
actress with no scientific training, she exposed the criminal
fraud perpetrated by Big Pharma and unknowing traditional
doctors in treating women with hormone replacement therapy using
synthetic drugs (that they called hormones) that exist nowhere
in nature. She pioneered bio-identical hormone therapy for
women. It took almost 15-20 years, but now, no woman will use
other than cheap bio-identical hormones available either over
the counter or through naturopathic physicians. She was
vilified, smeared, laughed at, etc., but in the end, most women
now recognize the fraud that the medical practitioners engaged
in. She even changed the name for hormone replacement therapy,
which used to be HRT, and now is Bio-identical hormone
replacement therapy …BHRT.
Which is to say, you don’t need any degrees to do good science.
As summarized by Mike Tomas, President and CEO of U.S. Stem Cell
Inc.,
”We are living in a historic time where we are witnessing the
emergence of stem cell therapy as a rapidly growing modality
that will soon become standard of care in modern medicine”.
We hope that this “modern medicine” will not only be
offered overseas!
The best three stem cell informational videos featuring Dr.
Kristin Comella:
https://www.youtube.com/watch?v=n3lou8PvarY
Why
Stem Cell Therapy Is the New Frontier in Medicine w/Dr.
Kristin Comella | TOT Revolution
https://www.youtube.com/watch?v=3Mzv9XkICg4
Dr.
Kristin Comella: Stem Cells -- An Idea Whose Time has Come!
STEM CELL THERAPY may be the greatest health care breakthrough
so far in this century! DO YOU OWN YOUR OWN CELLS? What can stem
cells do for you ... and how can you ACCESS this amazing tool?
It's all here is this powerful conversation. Important Contact
Information: Clinic website and phone number for contact:
http://www.usstemcellclinic.com
954-510-3150
http://www.usstemcellclinic.com
U.S. Stem Cell Clinic
U.S. Stem Cell Clinic is founded on the principle belief that
quality of life for our patients can be improved through stem
cell therapy.
We are a team of medical researchers and practitioners who work
hard to provide safe and effective treatments in our
point-of-care facilities.
Our clinic is committed to bringing proven stem cell treatment
options to the general public, both in the United States and
around the world.