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

by Paul Fassa Health 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 ...

Past Years of Hype Notwithstanding, Adult Stem Cells Are Now …

During the Great Embryonic Stem Cell Debate, circa 2001-2008, I watched the scientistsblatantly lie about the supposedly low potential for adult stem cells and the CURES! CURES! CURES that were just around the corner from embryonic stem cells. You remember: Children would soon be out of their wheelchairs and Uncle Ernies Parkinsons would soon be a disease of the past.

The pro-ESCR campaign was filled with so much disinformation and hype willingly swallowed by an in-the-tank media all in a corrupt attempt to overturn the minor federal funding restrictions over ESCR imposed by the President, and to hurt President Bush politically.

After the Bush presidency, the issue became quiescent. And now, it turns out that the clinical advances that have been made are not from embryonic stem cells.

During the debate, David A. Prentice a stem-cell researcher and my good friend took a sabbatical from his Indiana State University professorship to tout the great potential of adult stem cells (and to oppose human cloning) around the world. He became quite prominent in the debate for which he was punished by his universitys administration. For example, despite receiving teaching awards, he was moved from graduate classes and his lab privileges were curtailed.

Prentice eventually headed for The Swamp to continue his advocacy. He is now with the Charlotte Lozier Institute, where he has continued to track and educate about stem-cell science and engage policy controversies.

Prentice just published a major peer-reviewed article in the science journal Circulation Research, in which he details the amazing successes of adult stem-cell research demonstrating that the ESCR hypers had it wrong and he had it right.

Prentice outlines the many problems that make embryonic stem cells ill suited for clinical use, including the difficulty ofdifferentiating and integrating ES cells into the body, the problem that these cells have shown evidence of causing arrhythmia, the potential to cause tumors, and immunogenicity, in real peoples language, rejection caused by triggering the bodys immune response.

In contrast, ethical stem cells have had excellent successes. For example, induced pluripotent stem cells, which can be made from normal skin cells, are splendid for use in cell modeling and drug testing.

But Prentices primary focus is on adult stem cells, often taken from donor bone marrow or a patients own body. They have also not advanced as fast as was hoped, but they are progressing into clinical uses and human studies. From, Adult Stem Cells:

Not only do adult stem cells carry no ethical baggage regarding their isolation, their practical advantages over pluripotent stem cells have led to many current clinical trials, as well as some therapies approved through all phases of Food and Drug Administration testing.

Peer-reviewed, published successful results abound, with numerous papers now documenting therapeutic benefit in clinical trials and progress toward fully tested and approved treatments. Phase I/II trials suggest potential cardiovascular benefit from bone marrowderived adult stem cells and umbilical cord bloodderived cells.

Striking results have been reported using adult stem cells to treat neurological conditions, including chronic stroke. Positive long-term progression-free outcomes have been seen, including some remission, for multiple sclerosis, as well as benefits in early trials for patients with type I diabetes mellitus and spinal cord injury. And adult stem cells are starting to be used as vehicles for genetic therapies, such as for epidermolysis bullosa.

If this progress had been derived from embryonic stem cells, the headlines would have been deafening. The cheering from the media would include anchors dancing with pom-poms!

But the media isnt much interested in reporting adult stem-cell successes prominently because doing so doesnt promote favored ideological agendas. Thats not good journalism.

Prentice concludes:

The superiority of adult stem cells in the clinic and the mounting evidence supporting their effectiveness in regeneration and repair make adult stem cells the gold standard of stem cells for patients.

Thats excellent news for everyone, and may it continue.

But as we benefit from these ethical treatments, the next time ideologically driven scientists, bioethicists, and their media water carriers seek to drive public opinion on scientific issues in a partisan direction by deploying the propaganda tools of hype, exaggeration, and castigation of those who espouse heterodox views, remember how the Great Stem Cell Debate turned out.

Photo: An adult stem cell, by Robert M. Hunt [CC BY 3.0], via Wikimedia Commons.

Cross-posted at The Corner.

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Past Years of Hype Notwithstanding, Adult Stem Cells Are Now ...

Stem Cells & David A. Prentice — Adult Stem Cells Are Now …

(Luisa Gonzalez/REUTERS)

During the Great Embryonic Stem Cell Debate, circa 2001-2008, I watched the scientistsblatantly lie about the supposedly low potential for adult stem cells and the CURES! CURES! CURES that were just around the corner from embryonic stem cells. You remember: Children would soon be out of their wheelchairs and Uncle Ernies Parkinsons would soon be a disease of the past.

The pro-ESCR campaign was filled with so much disinformation and hype willingly swallowed by an in-the-tank media all in a corrupt attempt to overturn the minor federal funding restrictions over ESCR imposed by the president, and to hurt President Bush politically.

After the Bush presidency, the issue became quiescent. And now, it turns out that the clinical advances that have been made are not from embryonic stem cells.

During the debate, David A. Prentice a stem-cell researcher and my good friend took a sabbatical from his Indiana State University professorship to tout the great potential of adult stem cells (and to oppose human cloning) around the world. He became quite prominent in the debate for which he was punished by his universitys administration. For example, despite receiving teaching awards, he was moved from graduate classes and his lab privileges were curtailed.

Prentice eventually headed for The Swamp to continue his advocacy. He is now with the Charlotte Lozier Institute, where he has continued to track and educate about stem-cell science and engage policy controversies.

Prentice just published a major peer-reviewed article in the science journal Circulation Research, in which he details the amazing successes of adult stem-cell research demonstrating that the ESCR hypers had it wrong and he had it right.

Prentice outlines the many problems that make embryonic stem cells ill suited for clinical use, including the difficulty ofdifferentiating and integrating ES cells into the body, the problem that these cells have shown evidence of causing arrhythmia, the potential to cause tumors, and immunogenicity, in real peoples language, rejection caused by triggering the bodys immune response.

In contrast, ethical stem cells have had excellent successes. For example, induced pluripotent stem cells, which can be made from normal skin cells, are splendid for use in cell modeling and drug testing.

But Prentices primary focus is on adult stem cells, often taken from donor bone marrow or a patients own body. They have also not advanced as fast as was hoped, but they are progressing into clinical uses and human studies. From, Adult Stem Cells:

Not only do adult stem cells carry no ethical baggage regarding their isolation, their practical advantages over pluripotent stem cells have led to many current clinical trials, as well as some therapies approved through all phases of Food and Drug Administration testing.

Peer-reviewed, published successful results abound, with numerous papers now documenting therapeutic benefit in clinical trials and progress toward fully tested and approved treatments. Phase I/II trials suggest potential cardiovascular benefit from bone marrowderived adult stem cells and umbilical cord bloodderived cells.

Striking results have been reported using adult stem cells to treat neurological conditions, including chronic stroke. Positive long-term progression-free outcomes have been seen, including some remission, for multiple sclerosis, as well as benefits in early trials for patients with type I diabetes mellitus and spinal cord injury. And adult stem cells are starting to be used as vehicles for genetic therapies, such as for epidermolysis bullosa.

If this progress had been derived from embryonic stem cells, the headlines would have been deafening. The cheering from the media would include anchors dancing with pom-poms!

But the media isnt much interested in reporting adult stem-cell successes prominently because doing so doesnt promote favored ideological agendas. Thats not good journalism.

Prentice concludes:

The superiority of adult stem cells in the clinic and the mounting evidence supporting their effectiveness in regeneration and repair make adult stem cells the gold standard of stem cells for patients.

Thats excellent news for everyone, and may it continue.

But as we benefit from these ethical treatments, the next time ideologically driven scientists, bioethicists, and their media water carriers seek to drive public opinion on scientific issues in a partisan direction by deploying the propaganda tools of hype, exaggeration, and castigation of those who espouse heterodox views, remember how the Great Stem Cell Debate turned out.

See original here:
Stem Cells & David A. Prentice -- Adult Stem Cells Are Now ...

Adult stem cell therapies are coming to market – Jun. 16, 2009

NEW YORK (Fortune) -- When it comes to stem cells, the public -- and the media -- tend to focus on embryos. But researchers and analysts say marketable therapies already are emerging from less controversial work with adult stem cells.

Adult cells make up the lion's share of the stem cell space, mainly because they are easier to come by than embryonic cells, and less expensive to run in clinical trials. They are also derived from mature tissue, like bone marrow or umbilical cord blood, so they avoid the ethical debate that surrounds embryonic stem cells.

To be sure, many researchers consider embryonic stem cells to be more versatile, and they may someday be more useful than adult stem cells in treating diseases. But researchers also hope adult stem cells can help them combat a variety of maladies from diabetes to heart disease.

In fact, adult stem cells are currently the only type of stem cells used in transplants to treat diseases, such as cancers like leukemia.

Furthermore, researchers are far closer to commercializing drugs based on adult stem cells than any product based on embryonic stem cells.

The investment opportunities. But despite the differences between adult and embryonic stem cells, the stocks of all stem cell companies tend to trade in tandem. That's why the shares of adult stem cell companies also got a boost when the Obama administration decided to loosen restrictions on federal funding for embryonic stem cell research.

"Whatever is good for embryonic [stem cells] is good for adult [stem cells]. Investors at least at this point don't really tend to differentiate much between the two," says Ren Benjamin, a senior biotech analyst from Rodman & Renshaw.

Some analysts say investors should heed the differences. Robin Young, a medical industry analyst from RRY Publications, estimates that gross sales of adult cellular therapies will be well over $100 million in the United States this year. By 2018, he says stem cell therapy revenues could grow to $8.2 billion.

Indeed, several pharmaceutical companies are now taking notice of research advancements in adult stem cells -- and their proximity to reaching the market.

"Adult derived cells are the ones that have been studied for the past 10 to 15 years and are ready for prime time," says Debra Grega, the executive director of the Center for Stem Cell and Regenerative Medicine at Case Western Reserve University. "Large pharmaceutical companies are now wanting to get into the adult stem cell therapeutic area. That indicates to me that there is enough safety and enough efficacy that they are willing to put money in."

Pharmaceutical giant Pfizer (PFE, Fortune 500) announced in November that it would invest up to $100 million in regenerative research, which would include both adult and embryonic stem cell research, over a three to five year period. Ruth McKernan, the Chief Scientific Officer of Pfizer's Regenerative Medicine Unit, says she has observed more interest in regenerative medicine by other pharmaceutical companies as well.

The overall stem cell market, however, is still quite small. The California-based outfit Geron (GERN) dominates the embryonic market, and is perhaps 10 years away from commercializing a spinal cord treatment based on its research.

The frontrunner in the adult stem cell space is Osiris Therapeutics (OSIR). Last year, the biotech Genzyme (GENZ) paid Osiris $130 million up front, with another $1.2 billion to be paid in potential milestones, to develop two new adult stem cell treatments.

Osiris's star drug Prochymal is used to fight graft-versus-host disease, a painful illness that can afflict transplant recipients. Osiris says the FDA could approve the drug within a year. If successful, Osiris would be the first company to win approval for a stem cell drug.

Other companies moving forward in the adult stem cell space include Stem Cells Inc., Cytori, and Aastrom Biosciences.

And so while there's just one star in the embryonic stem cell universe, a whole constellation of adult stem cell drugs could be just around the corner.

First Published: June 16, 2009: 10:59 AM ET

Original post:
Adult stem cell therapies are coming to market - Jun. 16, 2009

Adult Cardiac Stem Cells Don’t Exist: Study | The Scientist …

Cardiac stem cell research has a turbulent history. Studies revealing the presence of regenerative progenitors in adult rodents hearts formed the basis of numerous clinical trials, but several experiments have cast doubt on these cells ability to produce new tissue. Some scientists are now lauding the results of a report published in April in Circulation as undeniable evidence against the idea that resident stem cells can give rise to new cardiomyocytes.

The concept of [many] clinical trials arose from the basic science in labs of a few individuals more than 15 years ago, and that basic science is whats now being called into question, says Jeffery Molkentin, a cardiovascular biologist at Cincinnati Childrens Hospital who penned an editorial about the latest work.

The first evidence supporting the notion of cardiac stem cells in adults emerged in the early 2000s, when researchers reported that cells derived from bone marrow or adult heart expressing the protein c-kit could give rise to new muscle tissue when injected into damaged myocardium in rodents. These studies caused some controversy right from the start, Molkentin says. The main reason that this struck a raw nerve with people is because we already know that heart, in human patients, doesnt regenerate itself after an infarct.

Early skepticism arose in 2004, when two separate groups of researchers published back-to-back papers refuting the claims that bone marrowderived c-kit cells could regenerate damaged heart tissue. Still, the concept of endogenous cardiac stem cells remained a mainstream idea until Molkentin and his colleagues published a study in 2014 reporting that c-kit cells in the adult mouse heart almost never produced new cardiomyocytes, says Bin Zhou, a cell biologist at the Chinese Academy of Sciences and a coauthor of the new study.

Although Molkentins findings were replicated shortly afterwards by two independent groups (including Zhous), some researchers held fast to the idea that cardiac progenitors could regenerate injured heart tissue. Earlier this year, a team of researchersincluding Bernardo Nadal-Ginard and Daniele Torella of Magna Graecia University in Italy and several other scientists who conducted the early work on c-kit cellspublished a paper reporting the flaws in the cell lineage tracing technique employed by Molkentin, Zhou, and their colleagues. For example, they noted that the method, which involved tagging c-kitexpressing cells and their progeny with a fluorescent marker, compromised the gene required to express the c-kit protein, impairing the progenitors regenerative abilities.

In the new Circulationstudy, Zhou and his colleagues used a different approach to examine endogenous stem cell populations in mice. Instead of tagging c-kit cells, the team applied a technique that would fluorescently label nonmyocytes and newly generated muscle cells a different color from existing myocytes. This method allowed the researchers to investigate all proposed stem cell populations, rather than specifically addressing c-kit cells. We wanted to ask the broader question of whether there are any stem cells in the adult heart, Zhou says.

These experiments revealed that, while nonmyocytes generate cardiomyocytes in mouse embryos, they do not give rise to new muscle cells in adult rodents hearts. The results also address the concerns raised about c-kit lineage tracing, Zhou tells The Scientist. We think our system can conclude that nonmyocytes cannot become myocytes in adults in homeostasis and after injury.

Torella says that hes not convinced by Zhous evidence. The main issue, he explains, is that the researchers did not explicitly test whether cardiac stem cells were indeed labeled as nonmyocytes to ensure that they were not inadvertently tagging them as myocytes instead.

Molkentin disagrees with this critique, stating that the only way the system would label a myocyte progenitor as a myocyte is if it was no longer a true stem cell, but instead an immature myocyte. Zhous group uses an exhausting and very rigorous genetic approach, he adds. My opinion is that we need to go back to the bench and conduct additional research to truly understand the mechanisms at play to better inform how we design the next generation of clinical trials.

Other scientists note that stem cells may not need to become new myocytes to help repair the injured heart. According to Phillip Yang, a cardiologist at Stanford University who did not take part in the work, many scientists now agree that stem cells are not regenerating damaged cardiomyocytes. Instead, he explains, a growing body of research now supports an alternative theory, which posits that progenitor cells secrete small molecules called paracrine factors that help repair injured heart cells. (Yang is involved in several stem cell clinical trials).

When you inject these stem cells, its pretty incontrovertible that they help heart function in a mouse injury model, Yang says. But the truth is, most of these cells are dead upon arrival [to the site of injury]. So the question is: Why is heart function still improving if these cells are dying?

Y. Li et al., Genetic lineage tracing of nonmyocyte population by dual recombinases, Circulation, 138:793-805, 2018.

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Adult Cardiac Stem Cells Don't Exist: Study | The Scientist ...

Adult Stem Cell Therapy for Osteoarthritis & Joint Injuries …

Adult Stem Cell Therapy for Osteoarthritis & Joint Injuries from a Premier Clinic for Regenerative Medicine

Adult stem cell therapy is an innovative, nonsurgical means of joint pain relief that allows many patients to delay or even eliminate the need for joint surgery. As a leading authority on the use and benefits of adult stem cell treatments and other forms of regenerative medicine, Dennis M. Lox, MD, is proud to offer this progressive therapy to his patients. He believes in educating his patients about their options for treatment so that they can make informed, confident decisions about their care. With his help, people throughout the nation have found relief from pain and achieved improved mobility with stem cell joint therapy. http://www.drlox.com

Stem cell therapy for joint injuries, arthritis, and similar conditions involves the use of adult stem cells, not embryonic stem cells, to regenerate tissue in joints that have succumbed to degeneration caused by age, osteoarthritis, injuries, and repetitive stress. Through a process called autologous transplantation, stem cells that are taken from your own body and processed while you wait are injected into the joint or tissue that is experiencing pain. This procedure is minimally invasive and can be performed right in the comfort of Dr. Loxs state-of-the-art clinic.

Adult stem cell therapy for the knee, hip, shoulder, and other areas can reduce inflammation and pain, as well as promote healing and repair. The conditions Dr. Lox treats with adult stem cell therapy include:

If youre in pain or had an injury and are looking for an alternative to surgery, in the United States, Canada or another country, contact us immediately at one of our locations. Our Main Medical Center located in Tampa Bay, Florida (727) 462-5582 or at Beverly Hills, California (310) 975-7033. http://www.drlox.com | info@drlox.com

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Adult Stem Cell Therapy for Osteoarthritis & Joint Injuries ...

David Lindsay: Adult Stem Cells Are Now The Gold Standard

During the Great Embryonic Stem Cell Debate, circa 2001-2008, I watched the scientistsblatantly lie about the supposedly low potential for adult stem cells and the CURES! CURES! CURES that were just around the corner from embryonic stem cells.

You remember: Children would soon be out of their wheelchairs and Uncle Ernies Parkinsons would soon be a disease of the past.

The pro-ESCR campaign was filled with so much disinformation and hype willingly swallowed by an in-the-tank media all in a corrupt attempt to overturn the minor federal funding restrictions over ESCR imposed by the president, and to hurt President Bush politically.

After the Bush presidency, the issue became quiescent. And now, it turns out that the clinical advances that have been made are not from embryonic stem cells.

During the debate, David A. Prentice a stem-cell researcher and my good friend took a sabbatical from his Indiana State University professorship to tout the great potential of adult stem cells (and to oppose human cloning) around the world.

He became quite prominent in the debate for which he was punished by his universitys administration. For example, despite receiving teaching awards, he was moved from graduate classes and his lab privileges were curtailed.

Prentice eventually headed for The Swamp to continue his advocacy. He is now with the Charlotte Lozier Institute, where he has continued to track and educate about stem-cell science and engage policy controversies.

Prentice just published a major peer-reviewed article in the science journalCirculation Research, in which he details the amazing successes of adult stem-cell research demonstrating that the ESCR hypers had it wrong and he had it right.

Prentice outlines the many problems that make embryonic stem cellsill suited for clinical use,including the difficulty ofdifferentiating and integratingES cells into the body, the problem that these cellshave shown evidence of causing arrhythmia,the potential to cause tumors, andimmunogenicity,in real peoples language, rejection caused by triggering the bodys immune response.

In contrast, ethical stem cells have had excellent successes. For example,induced pluripotent stem cells,which can be made from normal skin cells, are splendid for use in cell modeling and drug testing.

But Prentices primary focus is on adult stem cells, often taken from donor bone marrow or a patients own body. They have also not advanced as fast as was hoped, but they are progressing into clinical uses and human studies.

Not only do adult stem cells carry no ethical baggage regarding their isolation, their practical advantages over pluripotent stem cells have led to many current clinical trials, as well as some therapies approved through all phases of Food and Drug Administration testing.

Peer-reviewed, published successful results abound, with numerous papers now documenting therapeutic benefit in clinical trials and progress toward fully tested and approved treatments.

Phase I/II trials suggest potential cardiovascular benefit from bone marrowderived adult stem cells and umbilical cord bloodderived cells. Striking results have been reported using adult stem cells to treat neurological conditions, including chronic stroke.

Positive long-term progression-free outcomes have been seen, including some remission, for multiple sclerosis, as well as benefits in early trials for patients with type I diabetes mellitus and spinal cord injury. And adult stem cells are starting to be used as vehicles for genetic therapies, such as for epidermolysis bullosa.

If this progress had been derived from embryonic stem cells, the headlines would have been deafening. The cheering from the media would include anchors dancing with pom-poms! But the media isnt much interested in reporting adult stem-cell successes prominently because doing so doesnt promote favored ideological agendas. Thats not good journalism.

Prentice concludes:

The superiority of adult stem cells in the clinic and the mounting evidence supporting their effectiveness in regeneration and repair make adult stem cells the gold standard of stem cells for patients.

Thats excellent news for everyone, and may it continue. But as we benefit from these ethical treatments, the next time ideologically driven scientists, bioethicists, and their media water carriers seek to drive public opinion on scientific issues in a partisan direction by deploying the propaganda tools of hype, exaggeration, and castigation of those who espouse heterodox views, remember how the Great Stem Cell Debate turned out.

Read the rest here:
David Lindsay: Adult Stem Cells Are Now The Gold Standard

Neural stem cell – Wikipedia

Neural stem cells (NSCs) are self-renewing, multipotent cells that firstly generate the radial glial progenitor cells that generate the neurons and glia of the nervous system of all animals during embryonic development.[1] Some neural progenitor stem cells persist in highly restricted regions in the adult vertebrate brain and continue to produce neurons throughout life.

Stem cells are characterized by their capacity to differentiate into multiple cell types.[2] They undergo symmetric or asymmetric cell division into two daughter cells. In symmetric cell division, both daughter cells are also stem cells. In asymmetric division, a stem cell produces one stem cell and one specialized cell.[3] NSCs primarily differentiate into neurons, astrocytes, and oligodendrocytes.

There are two basic types of stem cell: adult stem cells, which are limited in their ability to differentiate, and embryonic stem cells (ESCs), which are pluripotent and have the capability of differentiating into any cell type.[2]

Neural stem cells are more specialized than ESCs because they only generate radial glial cells that give rise to the neurons and to glia of the central nervous system (CNS).[3] During the embryonic development of vertebrates, NSCs transition into radial glial cells (RGCs) also known as radial glial progenitor cells, (RGPs) and reside in a transient zone called the ventricular zone (VZ).[1][4] Neurons are generated in large numbers by (RPGs) during a specific period of embryonic development through the process of neurogenesis, and continue to be generated in adult life in restricted regions of the adult brain.[5] Adult NSCs differentiate into new neurons within the adult subventricular zone (SVZ), a remnant of the embryonic germinal neuroepithelium, as well as the dentate gyrus of the hippocampus.[5]

Adult NSCs were first isolated from mouse striatum in the early 1990s. They are capable of forming multipotent neurospheres when cultured in vitro. Neurospheres can produce self-renewing and proliferating specialized cells. These neurospheres can differentiate to form the specified neurons, glial cells, and oligodendrocytes.[5] In previous studies, cultured neurospheres have been transplanted into the brains of immunodeficient neonatal mice and have shown engraftment, proliferation, and neural differentiation.[5]

NSCs are stimulated to begin differentiation via exogenous cues from the microenvironment, or stem cell niche. Some neural cells are migrated from the SVZ along the rostral migratory stream which contains a marrow-like structure with ependymal cells and astrocytes when stimulated. The ependymal cells and astrocytes form glial tubes used by migrating neuroblasts. The astrocytes in the tubes provide support for the migrating cells as well as insulation from electrical and chemical signals released from surrounding cells. The astrocytes are the primary precursors for rapid cell amplification. The neuroblasts form tight chains and migrate towards the specified site of cell damage to repair or replace neural cells. One example is a neuroblast migrating towards the olfactory bulb to differentiate into periglomercular or granule neurons which have a radial migration pattern rather than a tangential one.[6]

Neural stem cell proliferation declines as a consequence of aging.[7] Various approaches have been taken to counteract this age-related decline.[8] Because FOX proteins regulate neural stem cell homeostasis,[9] FOX proteins have been used to protect neural stem cells by inhibiting Wnt signaling.[10]

Epidermal growth factor (EGF) and fibroblast growth factor (FGF) are mitogens that promote neural progenitor and stem cell growth in vitro, though other factors synthesized by the neural progenitor and stem cell populations are also required for optimal growth.[11] It is hypothesized that neurogenesis in the adult brain originates from NSCs. The origin and identity of NSCs in the adult brain remain to be defined.

The most widely accepted model of an adult NSC is a radial, astrocytes-like, GFAP-positive cell. Quiescent stem cells are Type B that are able to remain in the quiescent state due to the renewable tissue provided by the specific niches composed of blood vessels, astrocytes, microglia, ependymal cells, and extracellular matrix present within the brain. These niches provide nourishment, structural support, and protection for the stem cells until they are activated by external stimuli. Once activated, the Type B cells develop into Type C cells, active proliferating intermediate cells, which then divide into neuroblasts consisting of Type A cells. The undifferentiated neuroblasts form chains that migrate and develop into mature neurons. In the olfactory bulb, they mature into GABAergic granule neurons, while in the hippocampus they mature into dentate granule cells.[12]

NSCs have an important role during development producing the enormous diversity of neurons, astrocytes and oligodendrocytes in the developing CNS. They also have important role in adult animals, for instance in learning and hippocampal plasticity in the adult mice in addition to supplying neurons to the olfactory bulb in mice.[5]

Notably the role of NSCs during diseases is now being elucidated by several research groups around the world. The responses during stroke, multiple sclerosis, and Parkinson's disease in animal models and humans is part of the current investigation. The results of this ongoing investigation may have future applications to treat human neurological diseases.[5]

Neural stem cells have been shown to engage in migration and replacement of dying neurons in classical experiments performed by Sanjay Magavi and Jeffrey Macklis.[13] Using a laser-induced damage of cortical layers, Magavi showed that SVZ neural progenitors expressing Doublecortin, a critical molecule for migration of neuroblasts, migrated long distances to the area of damage and differentiated into mature neurons expressing NeuN marker. In addition Masato Nakafuku's group from Japan showed for the first time the role of hippocampal stem cells during stroke in mice.[14] These results demonstrated that NSCs can engage in the adult brain as a result of injury. Furthermore, in 2004 Evan Y. Snyder's group showed that NSCs migrate to brain tumors in a directed fashion. Jaime Imitola, M.D and colleagues from Harvard demonstrated for the first time, a molecular mechanism for the responses of NSCs to injury. They showed that chemokines released during injury such as SDF-1a were responsible for the directed migration of human and mouse NSCs to areas of injury in mice.[15] Since then other molecules have been found to participate in the responses of NSCs to injury. All these results have been widely reproduced and expanded by other investigators joining the classical work of Richard L. Sidman in autoradiography to visualize neurogenesis during development, and neurogenesis in the adult by Joseph Altman in the 1960s, as evidence of the responses of adult NSCs activities and neurogenesis during homeostasis and injury.

The search for additional mechanisms that operate in the injury environment and how they influence the responses of NSCs during acute and chronic disease is matter of intense research.[16]

Cell death is a characteristic of acute CNS disorders as well as neurodegenerative disease. The loss of cells is amplified by the lack of regenerative abilities for cell replacement and repair in the CNS. One way to circumvent this is to use cell replacement therapy via regenerative NSCs. NSCs can be cultured in vitro as neurospheres. These neurospheres are composed of neural stem cells and progenitors (NSPCs) with growth factors such as EGF and FGF. The withdrawal of these growth factors activate differentiation into neurons, astrocytes, or oligodendrocytes which can be transplanted within the brain at the site of injury. The benefits of this therapeutic approach have been examined in Parkinson's disease, Huntington's disease, and multiple sclerosis. NSPCs induce neural repair via intrinsic properties of neuroprotection and immunomodulation. Some possible routes of transplantation include intracerebral transplantation and xenotransplantation.[17][18]

An alternative therapeutic approach to the transplantation of NSPCs is the pharmacological activation of endogenous NSPCs (eNSPCs). Activated eNSPCs produce neurotrophic factors, several treatments that activate a pathway that involves the phosphorylation of STAT3 on the serine residue and subsequent elevation of Hes3 expression (STAT3-Ser/Hes3 Signaling Axis) oppose neuronal death and disease progression in models of neurological disorder.[19][20]

Human midbrain-derived neural progenitor cells (hmNPCs) have the ability to differentiate down multiple neural cell lineages that lead to neurospheres as well as multiple neural phenotypes. The hmNPC can be used to develop a 3D in vitro model of the human CNS. There are two ways to culture the hmNPCs, the adherent monolayer and the neurosphere culture systems. The neurosphere culture system has previously been used to isolate and expand CNS stem cells by its ability to aggregate and proliferate hmNPCs under serum-free media conditions as well as with the presence of epidermal growth factor (EGF) and fibroblast growth factor-2 (FGF2). Initially, the hmNPCs were isolated and expanded before performing a 2D differentiation which was used to produce a single-cell suspension. This single-cell suspension helped achieve a homogenous 3D structure of uniform aggregate size. The 3D aggregation formed neurospheres which was used to form an in vitro 3D CNS model.[21]

Traumatic brain injury (TBI) can deform the brain tissue, leading to necrosis primary damage which can then cascade and activate secondary damage such as excitotoxicity, inflammation, ischemia, and the breakdown of the blood-brain-barrier. Damage can escalate and eventually lead to apoptosis or cell death. Current treatments focus on preventing further damage by stabilizing bleeding, decreasing intracranial pressure and inflammation, and inhibiting pro-apoptoic cascades. In order to repair TBI damage, an upcoming therapeutic option involves the use of NSCs derived from the embryonic peri-ventricular region. Stem cells can be cultured in a favorable 3-dimensional, low cytotoxic environment, a hydrogel, that will increase NSC survival when injected into TBI patients. The intracerebrally injected, primed NSCs were seen to migrate to damaged tissue and differentiate into oligodendrocytes or neuronal cells that secreted neuroprotective factors.[22][23]

Galectin-1 is expressed in adult NSCs and has been shown to have a physiological role in the treatment of neurological disorders in animal models. There are two approaches to using NSCs as a therapeutic treatment: (1) stimulate intrinsic NSCs to promote proliferation in order to replace injured tissue, and (2) transplant NSCs into the damaged brain area in order to allow the NSCs to restore the tissue. Lentivirus vectors were used to infect human NSCs (hNSCs) with Galectin-1 which were later transplanted into the damaged tissue. The hGal-1-hNSCs induced better and faster brain recovery of the injured tissue as well as a reduction in motor and sensory deficits as compared to only hNSC transplantation.[6]

Neural stem cells are routinely studied in vitro using a method referred to as the Neurosphere Assay (or Neurosphere culture system), first developed by Reynolds and Weiss.[24] Neurospheres are intrinsically heterogeneous cellular entities almost entirely formed by a small fraction (1 to 5%) of slowly dividing neural stem cells and by their progeny, a population of fast-dividing nestin-positive progenitor cells.[24][25][26] The total number of these progenitors determines the size of a neurosphere and, as a result, disparities in sphere size within different neurosphere populations may reflect alterations in the proliferation, survival and/or differentiation status of their neural progenitors. Indeed, it has been reported that loss of 1-integrin in a neurosphere culture does not significantly affect the capacity of 1-integrin deficient stem cells to form new neurospheres, but it influences the size of the neurosphere: 1-integrin deficient neurospheres were overall smaller due to increased cell death and reduced proliferation.[27]

While the Neurosphere Assay has been the method of choice for isolation, expansion and even the enumeration of neural stem and progenitor cells, several recent publications have highlighted some of the limitations of the neurosphere culture system as a method for determining neural stem cell frequencies.[28] In collaboration with Reynolds, STEMCELL Technologies has developed a collagen-based assay, called the Neural Colony-Forming Cell (NCFC) Assay, for the quantification of neural stem cells. Importantly, this assay allows discrimination between neural stem and progenitor cells.[29]

The first evidence that neurogenesis occurs in certain regions of the adult mammalian brain came from [3H]-thymidine labeling studies conducted by Altman[30] and Das in 1965 which showed postnatal hippocampal neurogensis in young rats.[31] In 1989, Sally Temple described multipotent, self-renewing progenitor and stem cells in the subventricular zone (SVZ) of the mouse brain.[32] In 1992, Brent A. Reynolds and Samuel Weiss were the first to isolate neural progenitor and stem cells from the adult striatal tissue, including the SVZ one of the neurogenic areas of adult mice brain tissue.[24] In the same year the team of Constance Cepko and Evan Y. Snyder were the first to isolate multipotent cells from the mouse cerebellum and stably transfected them with the oncogene v-myc.[33] This molecule is one of the genes widely used now to reprogram adult non-stem cells into pluripotent stem cells. Since then, neural progenitor and stem cells have been isolated from various areas of the adult central nervous system, including non-neurogenic areas, such as the spinal cord, and from various species including humans.[34][35]

Intensity-modulated radiation to spare neural stem cells in brain tumors: a computational platform for evaluation of physical and biological dose metrics. Jaganathan A, Tiwari M, Phansekar R, Panta R, Huilgol N.

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A few questions about stem cells? | Yahoo Answers

Unless the last answer is coming from a different country, embryonic and fetal stem cells are NOT illegal.

Bush passed legislation that prevented federal funding from funding any embryonic or fetal stem cell research with the exception of a handful of projects that had already been proven contaminated or otherwise worthless.

The research was still legal and could be funded privately or even on a state level. However, since embryonic stem cell research is in its infancy, few private sources were willing to fund the research. Not only is it not 100% certain that the research will pay off, you are looking at 20-50 years at a min before this stuff is available publically and people start seeing returns on investments

Obama lifted the ban on federally funding embryonic stem cell research. However, with all the other economical issues, not much funding has been directed to it.

Embryonic stem cells come from IVF's trash pile. Women who go through IVF have their eggs harvested, they are fertalized with sperm in a lab and then frozen. WIth each mentstrual cycle, a few embryos at a time are inserted into the uterus hoping one will implant. They usually dont, it takes several cycles to produce a pregnancy, and all the embryos that dont implant die. When the mother is done trying to conceive, there are often embryos left over. Since most people going through IVF are doing so to have their own biological children, few are willing to donate their embryos to other women or accept donated embryos from other women. So, they are either incinerated as biowaste, or donated for research.

IVF kills more embryos than embryonic stem cell research, and will continue to, even if embryonic stem cell research stops today.

Fetal stem cell research is the least effective and least popular. But any woman can donate the remains from her abortion or naturally miscarried fetus.

C. is difficult to answer. Embryonic stem cells can turn into almost any type of cell in the body, however, early trials have led to cancer and other issues. Adult stem cells themselves arent turning cancerous after treatment (though keep in mind, they CAN become cancerous.... leukemia is cancer of the person's adult stem cells - their bone marrow.. If stem cells can turn cancerous before donation in the host body, they absolutely can after donation). Although, the most popular adult stem cell treatment is a bone marrow transplant, and that requires high dose chemo and full body radiation, which DOES increase the patients risk of cancers, including the same types that transplant treats.

In addition, adult stem cells have treatments, while embryonic stem cells dont. However, adult stem cells have been researched for about 100 years, and a bone marrow transplant has been available for 50. After all that time and research, they only have a handful of treatments. They just happened to get lucky because a bone marrow transplant can treat like 100+ different diseases - anything that originates or damages the blood system, marrow, or immune system.

Embryonic stem cells have only been researched for like 20-30 years. You wouldnt expect a treatment out of them, and precious adult stem cells took over 50 years to have a single succesful treatment in a single patient. If we had stopped adult stem cells after 20-30 years of research, we would never have anything that has come from it (and that is my debate against the people who claim embryonic stem cell research is worthless because it doesnt have treatments...... these people have no idea how long it took to develop a bone marrow transplant. and they have no idea how dangerous that transplant still is today, 50 years from its invention.

So, its really complicated and controversial.

I dont have any ethical issues against using bone marrow. My problem is that the bone marrow transplant is portrayed to be far safer than it really is. My problem is that anti embryonic people use the number of diseases this single treatment can treat to make it sound like adult stem cells have hundreds of different treatments, when they only have a handful. My problem is the misrepresentation of how long adult stem cell research has been conducted to make it look like they have accomplished way more than what they have in a way shorter amt of time. (for example, there is a particular user on ya that claims adult stem cells have only been researched for 20-30 years as well, but have hundreds of different treatments... its bs, based on manipulating the truth.)

The only people really against adult stem cell reserach are those against western medicine as a whole, and those who do not understand the difference bw adult and embryonic stem cells. I have been through a bone marrow transplant, so I am not against it. I just support being truthful about its flagship treatment.

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A few questions about stem cells? | Yahoo Answers

What are adult stem cells? – StemExpress Donor Center

What are adult stem cells?

Most cells in the adult body are specialized cell types. Specialized cell types are differentiated cells that serve a specific purpose in a particular tissue. For example, red blood cells are specifically designed to carry oxygen through the blood. Red blood cells perform their function for 100-120 days; new red blood cells are being formed daily to make sure the body gets its supply of oxygen. So where do these new red blood cells come from? In a process called hematopoiesis, stem cells located in your bone marrow and blood give rise to the cells in your blood, red and white blood cells. Stem cells are undifferentiated cells that exist in all tissues of the adult body and are capable of developing into specialized cells, not just blood cells but muscle, nerve, liver, etc. They function to replenish dying cells and maintain the overall health of our body.

How can studying adult stem cells help us?

Stem cells can be used to study the development of a specific cell type. More specifically scientist can learn about the genes that influence a stem cell to differentiate into a specific cell type. Why is this important? Understanding the developmental process of a specific cell type can help scientist identify genetic defects or how certain diseases arise. For example, at some point through a cells developmental process it can change and become diseased. What genes were involved in creating these changes? At what point in differentiation did this occur? What if there was a way to fix this gene and prevent the disease? These are just some of the questions scientists are trying to answer.

Stem cells can be used for drug discovery. Scientistsare searching for new drugs that improve stem cell function or alter the progress of a disease by identifying potential therapeutic compounds. For example, mesenchymal stem cells (MSCs) found in the bone marrow give rise to connective tissue such as bone, cartilage, and ligaments. What factors promote one specific cell type over the other? Can synthesizing this factor be used in drug therapy? Finding drugs that can promote bone regrowth could aid in alleviating osteoporosis or promote bone healing.

Stem cells can be used in cell replacement therapy. This treatment uses stem cells to generate healthy tissue that replaces damaged tissue caused by disease, aging or injury. For example, during a heart attack the heart sustains damage to not only the muscle tissue but the blood vessels as well. What if stem cells could be used to restore the function of the heart? Scientists have shown that transplanting healthy human stem cells into animal models with damaged hearts regenerates the heart muscle and blood vessels. Breakthroughs like this could potentially replace cardiac bypass surgery, a surgery that is often necessary to restore the blood flow to damaged area of the heart after a heart attack. Within recent years stem cells have been used in studies that target the treatment of Parkinsons, Alzheimers, spinal cord injury, stroke, severe burns, diabetes, arthritis, and leukemia.

What does StemExpress do with the stem cells isolated from your blood or bone marrow?

Isolating stem cells from donated samples of blood or bone marrow can be a time consuming and arduous process. At StemExpress we have developed the technology to isolate these cells quickly and efficiently. Upon request from scientists, isolated stem cells are sent off to their institution where they can begin their research immediately. Cells from StemExpress have been used in a wide variety of research areas, from inherited genetic disease therapies to cancer research.

As the scope of knowledge regarding stem cells expands so to will the potential for treatments of many debilitating diseases. It is donors like you that allow research like this to advance. Donate today and change the lives of tomorrow.

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What are adult stem cells? - StemExpress Donor Center