rexresearch.com



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.