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FDA Wants to Shut Down Adult Stem Cell Therapy as its Healing …

Posted: March 25, 2019 at 2:47 pm

by Paul FassaHealth Impact News

Adult stem cell therapy is enjoying widespread success around the world, but if the FDA gets its way, it may soon be banned here in the U.S.

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 patients own stem cells, so no patent-able drugs are involved.

They are targetingthe most influential stem cell scientist in the U.S., Dr.Kristin Comella in Florida.

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 ofregenerative 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 patients own adipose tissue and inject them into areas where that same patient needs repair. Its 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 clinics Chief Scientist isDr. 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 Comellaand her clinichave been under attack from theFDA.

This short 3-minute video was produced interviewing Dr. Comella and some of her patients.

Human embryonic stem cell (hESC) therapy has received most of the medias 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 theyre 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. Its relatively difficult and expensive compared to adipose (fat) tissue stem cell harvesting.

Bone marrows 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 wont 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 Comellas 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. Comellas leadership, she and her team have trained and certifiedmore than 700 physicians worldwide in adult stem cell therapy. (Source)

The interview below allows the energetic Dr. Kristin Comella to give a thorough and upbeat description of adult stem cell therapy.

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. (Source)

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 bodys own healing mechanism to overcome chronic ailments.

The FDA didnt and shouldnt have anything to do with regulating stem cells from ones 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 FDAs 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 the most influential clinician on the subject of adult stem cell therapy as its target. The FDA started doing inspections of Dr. Comellas South Florida clinic that aredesigned 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 inspectionsmade 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 affordmedical tourism.

Published on March 11, 2019

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FDA Wants to Shut Down Adult Stem Cell Therapy as its Healing ...

Recommendation and review posted by G. Smith

Stem Cell Therapy | Regenerative Orthopedics Institute

Posted: March 25, 2019 at 2:46 pm

As first described in 1988 by Dr. Arnold Caplan, mesenchymal stem cells are progenitor cells that have the power to differentiate into mature tissue cells. They are directly responsible for healing damaged tissues after injury. Upon encountering damaged tissue, they release proteins that decrease inflammation and trigger growth of new connective tissues and blood vessels, stimulating tissue repair and regeneration. In the case of severe damage and cell death, these cells have the ability to turn into healthy versions of the damaged or destroyed cells that they encounter.

At Regenerative Orthopedics we take stem cells from your own bone marrow or from your own fat or both. Under sterile conditions, they are then washed, concentrated and isolated under direct supervision by Dr. Smith in our office laboratory. We combine these cells with platelet rich plasma isolated from your blood drawn at the same time we harvest your cells. This mixture is then injected into the affected area.

Every joint in the body and most tissues contain stem cells that are responsible for maintaining health in that location. Degeneration of tissues or joints occur when the stem cell population becomes depleted and that structure losses its ability to heal itself as a result of injury of the natural aging process. Stem cell therapy is an attempt to repopulate tissues or joints with stem cells thereby restoring the bodys ability to heal itself.

Upon establishing that you are a candidate for treatment, we will decide whether to harvest stem cells from your bone marrow or from your fat or both. We recommend most patients undergo a minor arthroscopic procedure just prior to the stem cell treatment called microfracture where small holes are made in the end of the affected bone. This is in effect a bone marrow harvest as it allows stem cells from the bone marrow to enter the joint. Because these are not concentrated, the second part of the procedure will consist of harvesting Adipose derived stem cells or in other words stromal vascular fraction and using these stem cells to augment the procedure by injecting them into the affected joint.

Adipose tissue consists of adipocytes (fat cells) and the stromal vascular fraction (SVF). The stomal vascular fraction which contains millions of unused stem cells is harvested through a process known as lipoaspiration. Lipoaspiration is performed under local anesthetic in the office using a small instrument slightly larger a hypodermic needle. About 60 ml of fat is aspirated during lipoaspiration which differs from liposuction in which volumes of up to 6 ,000 ml of fat is removed. Once the fat is obtained, the stromal vascular fraction is isolated in the lab through a process that involves washing the fat then mixing it with an enzyme that causes the stem cells to detach from the fat cells. Final isolation involves the use of a centrifuge for final separation of the cells. These cells are then mixed with PRP and isolated from the patients own blood. Prior to injection, the mixture is then activated using photo-modulation.

Bone marrow is rich in growth factors and stem cells. We are able to obtain these cells in the office under local anesthesia in a very simple procedure that requires a relatively small amount of bone marrow and only one puncture site. This is vastly different that harvesting bone marrow for transfusion for cancer therapies. This technique will be utilized in the event that the patient has minimal fat deposits from which to obtain stem cells. Unlike SVF, bone marrow stem cell aspiration is not concentrated and so the amount of stem cells that can be isolated from this technique decrease with increasing age. For most patients, their bone marrow will be utilized and accessed through microfracture as described above.

Because these therapies stimulate the normal growth and repair processes, they rarely provide immediate relief unlike steroid injections. However, the results are much longer lasting. Typically, it takes between two and eight weeks before patients notice significant improvement.

These treatments are intended to reverse tissue damage and degenerative changesbut they do not stop the natural aging process which starts again once the tissues have regenerated. Overall, these therapies should provide good relief of pain from two to six years after treatment. Patients will require repeat treatment throughout their life as they get older and joints continue to degenerate.

No. Although these treatments are done worldwide and have been proven an effective alternative for treatment of pain related to damage and degeneration of joints, they are still considered experimental and not covered by insurance plans. Payment is due at the time of service.

Maintain a regular exercise program that is not excessive. Eat well and get enough sleep. Avoid excessive alcohol drinking and no smoking. Dr. Smith will also recommend an appropriate vitamin supplement to optimize stem cell function.

Regenerative Orthopedics does not culture, manipulate or save your cells. The process we utilize to obtain your stem cells results in the harvesting of cells in the range of 2 to 4 million stems cells and so there is no need to manipulate or grow your cells in the lab.

We keep our office overhead down by maintaining a small office staff and a small but adequately sized office. We also keep advertising to a minimum because most of our patients are referred by other patients and word of mouth referrals. This allows us to pass our cost savings on to you the patients.

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Stem Cell Therapy | Regenerative Orthopedics Institute

Recommendation and review posted by G. Smith

Chemistry, B.S. < Temple University

Posted: March 25, 2019 at 2:43 pm

Learn more about the Bachelor of Science in Chemistry.

The Bachelor of Science in Chemistry prepares students for excellence in graduate or medical school, and employment in the chemical, biotechnological, or pharmaceutical industries. Students learn a wide array of topics in Chemistry, Mathematics, and Physics. The program emphasizes the "hands-on" nature of chemistry in laboratory courses, giving students the tools that chemists need to pursue research. They also learn how to write scientific reports, analyze data, and place these results in a broader scientific context. Accomplished majors are encouraged to pursue independent research with a professor, and to present their work internally and at national meetings.

Undergraduate Contact Information:

Dr. Dan Strongin, ChairBeury Hall, Room 130215-204-7118

Dr. Ann Valentine, Vice ChairBeury Hall, Room 352215-204-7118

Dr. Steven Fleming, Faculty Advisor (Last names A-C)Beury Hall, Room [email protected]

Dr. Roy Keyer, Faculty Advisor (Last names D-G)Beury Hall, Room [email protected]

Dr. Spiridoula Matsika, Faculty Advisor (Last names H-K)Beury Hall, Room [email protected]

Dr. Andrew Price, Faculty Advisor (Last names L-M)Beury Hall, Room [email protected]

Dr. Vince Voelz, Faculty Advisor (Last names N-R)Beury Hall, Room [email protected]

Dr. Vladi Wilent, Faculty Advisor (Last names S-T)Beury Hall, Room [email protected]

Dr. Michael Zdilla, Faculty Advisor (Last names U-Z)SERC, Room [email protected]: Due to restricted access to the 6th floor of SERC, please email Dr. Zdilla to set up an appointment.

MATH0701 (4 s.h.) and/or ENG0701(4 s.h.), if required by placement testing.

All Temple students must take a minimum of two writing-intensive courses at Temple as part of their major.Following is a list of courses that can be used to satisfy the writing-intensive requirement:

College Requirements

45 Upper Level (2000+) credits within the College of Science & Technology (CST) or the College of Liberal Arts (CLA).

90 credits within the College of Science & Technology (CST) or the College of Liberal Arts (CLA).

Major Requirements for Bachelor of Science (70-74 s.h.)At least 9 courses required for the major must be completed at Temple. At least 7 Chemistry courses must be completed at Temple.

Courses listed under the major requirements for the degree will be included in the calculation of the major GPA. Courses that could not apply toward the major as an elective or required course would not be counted in the calculation of the major GPA. This would include CHEM1027, for example.

To graduate with Distinction in Major, students are required to achieve a 3.33 GPA or higher in all the Chemistry courses in their major.

All prospective majors should schedule an appointment with one of the departmental advisors (names of current Faculty Advisors are available in the About section) to plan a program of study. The recommended order of courses for the major is listed below; a different order is acceptable as long as the student adheres to prerequisite requirements.

Advanced Science Courses for B.S. students consist of:

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Chemistry, B.S. < Temple University

Recommendation and review posted by G. Smith

What Is Biochemistry? – Introduction and Overview

Posted: March 25, 2019 at 12:49 am

Biochemistry is the science in which chemistry is applied to the study of living organisms and the atoms and molecules which comprise living organisms. Take a closer look at what biochemistry is and why the science is important.

Biochemistry is the study of the chemistry of living things. This includes organic molecules and their chemical reactions. Most people consider biochemistry to be synonymous with molecular biology.

The principal types of biological moleculesor biomolecules are:

Many of these molecules are complex molecules called polymers, which are made up of monomer subunits. Biochemical molecules are based on carbon.

Many biochemists work in chemistry labs. Some biochemists may focus on modeling, which would lead them to work with computers. Some biochemists work in the field, studying a biochemical system in an organism. Biochemists typically are associated with other scientists and engineers. Some biochemists are associated with universities and they may teach in addition to conducting research. Usually, their research allows them to have a normal work schedule, based in one location, with a good salary and benefits.

Biochemistry is closely related to other biological sciences that deal with molecules. There is considerable overlap between these disciplines:

Excerpt from:
What Is Biochemistry? - Introduction and Overview

Recommendation and review posted by G. Smith

List of British monarchs by longevity – Wikipedia

Posted: March 25, 2019 at 12:48 am

Wikimedia list article

This is a list of British monarchs by longevity since the Union of the Crowns of England, Scotland and Ireland in 1603. To maintain consistency within the table, the dates of birth and death for each monarch are given in New Style. Two measures of the longevity are giventhis is to allow for the differing number of leap days occurring within the life of each monarch. The first column is the number of days between date of birth and date of death, allowing for leap days; the second column breaks this number down into years, and days, with the years being the number of whole years the monarch lived, and then days after his or her last birthday. Elizabeth II (queen since 6 February 1952), is the longest lived British sovereign.

*Updated daily according to UTC. While Queen Victoria lived for only 4 days more than George III in terms of years and days format, she actually lived for five days more because there were 20 leap days during Victoria's life and only 19 leap days during the life of George III.

If Charles, Prince of Wales, were to accede to the throne, he would immediately be ranked 8th with an age of 70years, 119days. If instead his son, William, Duke of Cambridge, were to accede any time before September 2030, he would be ranked 18th.

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List of British monarchs by longevity - Wikipedia

Recommendation and review posted by G. Smith

Grand Challenge for Healthy Longevity – National Academy …

Posted: March 25, 2019 at 12:47 am

Dramatic breakthroughs in medicine, public health, and social and economic development have resulted in unprecedented extensions of the human lifespan across the world over the past century. This triumph for humanity provides new opportunities as well as new challenges. Globally, we are facing a major demographic shift. Today, 8.5% of people worldwide (617 million) are aged 65 and over. By 2050, this percentage is projected to more than double, reaching 1.6 billion. The global population of the oldest oldpeople aged 80 and olderis expected to more than triple between 2015 and 2050, growing from 126 million to 447 million.

At the current pace, population aging is poised to impose a significant strain on economies, health systems, and social structures worldwide. But it doesnt have to.We can envision, just on the horizon, an explosion of potential new medicines, treatments, technologies, and preventive and social strategies that could help transform the way we age and ensure better health, function, and productivity during a period of extended longevity. Multidisciplinary solutions are urgently needed to maximize the number of years lived in good health and a state of well-being. Now is the time to support the next breakthroughs in healthy longevity, so that all of us can benefit from the tremendous opportunities it has to offer.

Register to get updates!

The National Academy of Medicine is launching a Grand Challenge for Healthy Longevity a major initiative to catalyze transformative innovation and inform policies and priorities to advance healthy aging and longevity globally. The initiative will have two components: a series of inducement prizes and awards to stimulate innovation and transform the field; and a comprehensive global roadmap report that will assess the challenges and opportunities of global aging with recommendations for action. The combined objectives of the initiative are to:

The Healthy Longevity Challenge Awards and Prizes will engage innovators, scientists, and entrepreneurs as they compete to catalyze breakthrough discoveries and technologies that will transform the field and stimulate new research and solutions around healthy longevity. The NAM has developed a model of major inducement prizes for breakthrough innovations built on a foundation of catalyst and proof-of-concept awards.

The Challenge will roll out over three distinct phases and employ a tiered model of awards and prizes. Phases 1-2 will prospectively fund new, bold ideas and advance promising research through catalyst and challenge awards respectively. Phase 3 will issue grand prizes to reward the achievement of bold, transformative innovations representing the culmination of previous research.

The Global Roadmap for Healthy Longevity will produce a comprehensive report assessing the challenges presented by global aging and demonstrating how these challenges can be translated into opportunities for societies globally through levers across policy, practice, and socioeconomic infrastructure. The report will be informed by workstreams in three domains: 1) research and innovation; 2) design and operation of healthcare delivery systems; and 3) social, economic, and physical enablers. Across these domains, particular considerations will be given to: policy and practice, health equity and disparities, technology solutions, sustainable financing, and monitoring metrics. The initiative will bring together thought leaders from science, medicine, health care systems, engineering, technology, economics, and policy to identify the necessary priorities and directions for improving health, productivity, and quality of life for older adults worldwide.

Fundraising for the Healthy Longevity Grand Challenge is ongoing. To learn more about the program or ways to get involved, please contact Elizabeth Finkelman at [email protected].

Register to get updates!

Laura Carstensen of the Stanford Center on Longevity delivers the keynote address at the 2015 NAM Annual Meeting

Innovation in Aging:Victor Dzau, Hal Barron, Joe Coughlin, J. Craig Venter, and Joon Yun

Grand Challenge for Healthy Longevity - National Academy ...

Recommendation and review posted by G. Smith

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