DAVID GRANOVSKY

Posts Tagged ‘fda’

FDA GETTING INTO STEM CELLS?

In STEM CELLS IN THE NEWS on April 23, 2014 at 4:23 pm
http://repairstemcell.files.wordpress.com/2014/04/e6851-mk7.jpg?w=582&h=331
 
IS THE FDA FINALLY, PUBLICLY, GETTING INTO STEM CELLS?
Better late than never…14 years after serious adult stem cell research began in other parts of the world, the FDA finally woke up and they are beginning, BEGINNING to research adult stem cells. They even made a positive statement about their regenerative promise. We’ll call this one a victory in that the outcry for adult stem cells has been so loud, the FDA finally relented and have begun research. Better late than never. Thanks for coming to the party FDA…

But…14 years late to the party. Reminds me of the last scene in Schindler’s list. How many lives could have been saved? How much suffering could have been eased. Well, let’s do the math.

“…in 2005 there were 2,448,000 deaths in the u.s.
4 of the top 6 killers were:

Heart disease (652,000 deaths)
Cancer (559,000 deaths)
Stroke (143,000 deaths)
Diabetes (75,000 deaths)

There were a total of 1,429,000 deaths in 2005 from these 4 diseases and there are renowned stem cell treatment centers around the world that have been successfully treating patients with these disease for years. Around the world, people with these disease are actively receiving asc treatments and benefiting from them.

How many of those 1,429,000 deaths in the USA Could have been averted with asc treatment? How many of those 1,429,000 lives in the u.s. Could have been extended with asc treatment until other treatments were available? We’ll never know. Maybe we could have saved 30% of those people with asc or 428,700 people per year. Over 10 years that might amount to 4,287,000 people saved.

Saving 10% = 142,900 per year or 1,429,000 people saved in 10 years.
Even saving just 2% = 28,580 people per year amounts to 285,800 over 10 years.” [With a potential of 15,000,000 saved over 10 years.]
via http://repairstemcell.wordpress.com/stem-cells-101/

So when the FDA starts tooting their horn about showing up to the party, doing great research, working on unprecedented projects, the promise of adult stem cells and the ultimate success they will achieve…remind them they are doing so on the tail coats of the innumerable scientists, doctors and patients who have blazed the path before them…and please remind them to apologize to the millions who have died waiting for stem cell treatments in the USA. http://repairstemcell.wordpress.com/why-no-stem-cells-in…/

http://www.fda.gov/ForConsu…/ConsumerUpdates/ucm393030.htm

WHAT PRICE HEALTH?

In STEM CELLS IN THE NEWS on April 2, 2013 at 4:02 pm

http://www.defendingfoodsafety.com/uploads/image/FDA%20-%20Grant%20Money.jpg

Greg said:

“Dave, word on the grapevine is a few stem cell professionals almost or did come to blows over the FDA nonsense. They couldn’t understand how the FDA has been stonewalling them when the FDA has okayed dangerous drugs with far less data and safety.”

I responded:

“This has been going on for some time. Simply put, there are a number of docs and treatment centers that are leading the charge, a full frontal assault on the FDA to obtain the right (which should not be something they need to petition for) to use autologous (from the patient’s own body) adult stem cells for treatment. There are a number of regulations that need to be met and federal, state and local law before one can treat in the USA. Almost nobody knows how to do this. Even those that do, can still come under fire and spend their entire war chest battling in the courts. Even if you win over and over, you still can waste valuable time, money and energy better spent treating patients and researching protocols and developing ideas.

There are also many patient groups who are actively lobbying for these rights and numerous petitions floating around. The call to arms I recently wrote which I am putting the finishing touches on, entitled “The Public Wants Stem Cell Treatments” addresses these issues directly. These are the front lines my friends and the docs and patients are on one side and the FDA and upstart regulatory bureaus trying to get a market share of stem cell regulation are on the other. Welcome to the wild west. The mortars and shrapnel are flying and anyone who sticks their head out of the fox hole will incur a mortal wound.

The number of hoops required to jump through are daunting and almost nobody knows how and fewer are willing to take the chance but the potential upside is thousands, tens of thousands, hundreds of thousands, millions of chronic and terminally ill patients with incurable disease recovering, going into remission, reclaiming their health and their lives.

What’s the value of that? What price can we put on our health? I’m reminded of the old credit card commercials…

Chronic disease = $30-150,000 per year
Loss of income from inability to work = $30-150,000 per year
Adult stem cell treatment = $8 – 10,000
Living without symptoms after treatment = Priceless
Living to see your daughter married = Priceless
Living to see your grandchild born = Priceless
Living without pain = Pricelesshttp://www.statusant.com/large/Today-be-thankful-and-think-how-rich-you-are.-Your-family-is-priceless%7C2C-your-time-is-gold-and-your-health-is-wealth.-status.jpgRelated articles

IBD PATIENTS SOON TO BE TREATED WITH STEM CELLS

In SCIENCE & STEM CELLS, STEM CELLS IN THE NEWS on March 4, 2013 at 9:02 am

mix_bowel diagram

Research Supports Promise of Cell Therapy for Bowel Disease

Researchers have identified a special population of adult stem cells in bone marrow that have the natural ability to migrate to the intestine and produce intestinal cells, suggesting their potential to restore healthy tissue in patients with inflammatory bowel disease (IBD).

Up to 1 million Americans have IBD, which is characterized by frequent diarrhea and abdominal pain. IBD actually refers to two conditions — ulcerative colitis and Crohn’s disease — in which the intestines become red and swollen and develop ulcers, probably as the result of the body having an immune response to its own tissue.

While there is currently no cure for IBD, there are drug therapies aimed at reducing inflammation and preventing the immune response. Because these therapies aren’t always effective, scientists hope to use stem cells to develop an injectable cell therapy to treat IBD.  The research findings are reported online in the FASEB Journal (the journal of the Federation of American Societies for Experimental Biology) by senior researcher Graca Almeida-Porada, M.D., Ph.D., professor of regenerative medicine at Wake Forest Baptist’s Institute for Regenerative Medicine, and colleagues.

The new research complements a 2012 report by Almeida-Porada’s team that identified stem cells in cord blood that are involved in blood vessel formation and also have the ability to migrate to the intestine.  “We’ve identified two populations of human cells that migrate to the intestine — one involved in blood vessel formation and the other that can replenish intestinal cells and modulates inflammation,” said Almeida-Porada. “Our hope is that a mixture of these cells could be used as an injectable therapy to treat IBD.”

The cells would theoretically induce tissue recovery by contributing to a pool of cells within the intestine. The lining of the intestine has one of the highest cellular turnover rates in the body, with all cell types being renewed weekly from this pool of cells, located in an area of the intestine known as the crypt.  In the current study, the team used cell markers to identify a population of stem cells in human bone marrow with the highest potential to migrate to the intestine and thrive. The cells express high levels of a receptor (ephrin type B) that is involved in tissue repair and wound closure.

The cells also known to modulate inflammation were injected into fetal sheep at 55 to 62 days gestation. At 75 days post-gestation, the researchers found that most of the transplanted cells were positioned in the crypt area, replenishing the stem cells in the intestine.

“Previous studies in animals have shown that the transplantation of bone-marrow-derived cells can contribute to the regeneration of the gastrointestinal tract in IBD,” said Almeida-Porada.

http://www.wakehealth.edu

ATHLETES PROLONG CAREER THROUGH STEM CELLS TREATMENTS

In ALL ARTICLES, Athletes & Stem Cells, VICTORIES & SUCCESS STORIES on February 11, 2013 at 9:08 am

peyton manning

Chasing the miracle cure

Jim Bradley understands the season-on-the-brink desperation that, according to Fox Sports, sent Peyton Manning and his ailing neck to Europe this summer, seeking the experimental promise of stem cells. For the past two decades as the Steelers orthopedist, Bradley has listened to injured athletes beg him to be creative in getting them back onto the field. “In the last year, I’ve seen half a dozen guys go to South Korea, Japan, Germany, even Russia for stem cell procedures,” says Bradley, a past president of the NFL Physician’s Society. “And there’s going to be plenty more.”

hines-ward

The 57-year-old doctor should know. In January 2009, after Hines Ward left the AFC championship game with a torn MCL, Bradley administered a form of platelet-rich plasma (PRP) therapy, a strange and novel procedure at the time. Placing a sample of Ward’s blood in a centrifuge, Bradley isolated the plasma and platelets, which contain natural repair engines, then reinjected the serum into the receiver’s injured knee. Ward returned to the field two weeks later for Super Bowl XLIII, a remarkable recovery he and Bradley credit to the procedure. Had the Steeler opted for rest and physical therapy instead, the two say Ward likely would have watched the big game from the sideline.

At the time, Bradley was hailed as a genius; weekend warriors everywhere started asking for the “Hines Ward treatment.” But compared with the latest stem cell technologies, PRP looks about as revolutionary as leeches. Instead of relying on the relatively small number of stem cells that swim in blood, cellular scientists elsewhere in the world are extracting millions more out of bone marrow and fat, then engineering them into injury-fighting miracle workers. In Europe, healthy top-level soccer players are already having their stem cells harvested and grown into lines of bone and connective tissue in case of injury. “They’re doing it so they’ll have a ligament line ready if they get a tear during the season,” Bradley says.

Jarvis Green

Until last year, Christopher Centeno was doing a booming business culturing mesenchymal stem cells at his Broomfield, Colo., clinic. When NFL defensive end Jarvis Green visited the doctor in 2010 after two failed knee surgeries, the player faced the end of an eight-year career with New England. Shortly after receiving his stem cell treatment, Green was back in the NFL. “Before, I couldn’t walk up the stairs,” he told The Mag. “Three weeks later, I went to an NFL training camp and didn’t miss a day.”

Green’s recovery gave him one more season, with Houston, before he retired. But he had one of the last seats on Centeno’s cultured stem cell miracle train. In August 2010, the U.S. Food and Drug Administration filled a federal injunction to prevent Centeno from culturing stem cells. The FDA claims he was “adulterating” blood in a way that turned it into an unapproved new drug. Centeno, who still provides same-day stem cell procedures, has spent $500,000 fighting the agency’s controversial opinion and even more money moving his culturing operation to a new clinic offshore in the Cayman Islands. “The FDA has pushed this therapy out of the U.S.,” he says.

Source:   Oct. 17 issue of ESPN The Magazine.

PLURUIPOTENT STEM CELLS, A POTENTIALLY INVALUABLE THERAPEUTIC RESOURCE

In SCIENCE & STEM CELLS on November 21, 2012 at 7:44 am

B0007671 Mouse embryonic stem cells

Pluripotent stem cells are potentially an invaluable therapeutic resource, as shown in a recent study conducted by the Stanford University School of Medicine.  Within this study, researchers found that with appropriate initial coaching of cells and through the use of environmental cues, the human body has the ability to direct differentiation of cells.

 

Pluripotent stem cells are nature’s double-edged sword. Because they can develop into a dizzying variety of cell types and tissues, they are a potentially invaluable therapeutic resource. However, that same developmental flexibility can lead to dangerous tumors called teratomas if the stem cells begin to differentiate out of control in the body.

To prevent this outcome, researchers must first give the cells a not-so-subtle shove toward their final developmental fate before transplanting them into laboratory animals or humans. But exactly how to do so can vary widely among laboratories. Now researchers at the Stanford University School of Medicine have used an experiment in mice to hit upon a way to possibly skip this fiddly step by instead relying mostly on signals within the body to keep the stem cells in line.

“Before we can use these cells, we have to differentiate, or ‘coach,’ them down a specific developmental pathway,” said Michael Longaker, MD, the Deane P. and Louise Mitchell Professor in the School of Medicine. “But there’s always a question as to exactly how to do that, and how many developmental doors we have to close before we can use the cells. In this study, we found that, with appropriate environmental cues, we could let the body do the work.”

Allowing the body to direct differentiation could speed the U.S. Food and Drug Administration’s approval of using such pluripotent stem cells, Longaker believes, by eliminating the extended periods of laboratory manipulation required during the forced differentiation of the cells.

Longaker, who co-directs Stanford’s Institute for Stem Cell Biology and Regenerative Medicine, is the senior author of the research, published online Nov. 19 in the Proceedings of the National Academy of Sciences. Postdoctoral scholars Benjamin Levi, MD, and Jeong Hyun, MD, and research assistant Daniel Montoro are co-first authors of the work. Longaker is also a member of the Stanford Cancer Institute.

“Once we identify the key proteins and signals coaching the tissue within the body, we can try to mimic them when we use the stem cells,” said Longaker. “Just as the shape of water is determined by its container, cells respond to external cues. For example, in the future, if you want to replace a failing liver, you could put the cells in a scaffold or microenvironment that strongly promotes liver cell differentiation and place the cell-seeded scaffold into the liver to let them differentiate in the optimal macroenvironment

http://med.stanford.edu/ism/2012/november/longaker.html

MAKING SENSE OF THE FDA AND STEM CELLS – WSJ OPED

In STEM CELLS IN THE NEWS on April 15, 2012 at 11:06 pm


By ANDREW VON ESCHENBACH-WSJ 4/15/12-See
http://online.wsj.com/articleSB10001424052702303815404577331673917964962.html?mod=googlen
ews_wsj

When I was commissioner of the Food and Drug Administration (FDA) from 2005 to 2009, I saw firsthand how regenerative medicine offered a cure for kidney and heart failure and other chronic conditions like diabetes. Researchers used stem cells to grow cells and tissues to replace failing organs, eliminating the need for expensive supportive treatments like dialysis and organ transplants.

But the beneficiaries were laboratory animals. Breakthroughs for humans were and still are a long way off. They have been stalled by regulatory uncertainty, because the FDA doesn’t have the scientific tools and resources to review complex innovations more expeditiously and pioneer regulatory pathways for state-of-the-art therapies that defy current agency conventions. Fortunately, Congress may have an opportunity as soon as this week to begin changing that.

The FDA isn’t obstructing progress because its employees are mean-spirited or foolish. But for decades, Congress has starved the agency of critical funding, limiting its scientists’ ability to keep up with peers in private industry and academia. The result is an agency in which science-based regulation often lags far behind scientific discovery. This forces the FDA to slow the approval of new treatments—and at times
creates acrimonious litigation between the FDA and innovators, not to mention disillusionment among desperate patients.

For example, in August 2010, the FDA filed suit against a company called Regenerative Sciences. Three years earlier, the company had begun marketing a process it called Regenexx to repair damaged joints by injecting them with a patient’s own stem cells. The FDA alleged that the cells the firm used had been manipulated to the point that they should be regulated as drugs. A resulting court injunction halting use of the technique has cast a pall over the future of regenerative medicine.

From the agency’s perspective, it had only called a “time out” until it could apply its regulatory process designed to analyze the therapy’s effectiveness and potential risks. For the industry, however, government had intervened in a way that seemed to bar the established clinical practice of using an individual’s own cells to advance the healing process.

Lawyers—many lawyers—are now trying to resolve this dispute. But at a time when science and technology are creating marvelous medical breakthroughs, the FDA should be leading and guiding the development of state-of-the-art therapies like regenerative medicine. Instead, the agency’s process for regulating complex new technologies often starts too late, after companies and researchers have sunk millions of dollars and thousands of hours into painstaking research.

It makes far better sense for the FDA to work collaboratively with physicians, patients, companies and academic researchers to craft standards for evaluating new technologies while they are still being developed, not years later when a company makes a marketing application for a breakthrough product.

Until that time, FDA scientists typically have little contact with the scientists who know the most about these innovative technologies.

This is not because they don’t want to. But consumer groups distrustful of industry have led Congress to erect ever greater barriers between regulators and those they regulate. The FDA can convene advisory committees of outside experts, but these experts weigh in only at the end of the regulatory process.

Worse, congressionally mandated conflict-of-interest rules keep many of the most knowledgeable academic and industry scientists off advisory committees out of fear that industry ties might bias their judgment.

Meanwhile, budget constraints have eroded the agency’s scientific foundations. When I moved from director of the National Cancer Institute at the National Institutes of Health (NIH) to become FDA commissioner in 2005, I was surprised to learn there are no provisions for continuous education to acquire new skills in emerging fields such as stem-cell biology, nanotechnology or computational biology. Even sending agency staff to academic conferences provoked a congressional outcry over meeting and travel costs.

If we want the FDA to lead innovation, and not lag behind it, Congress must give the agency the resources to be the world’s foremost science-based regulatory agency. It should endorse formal career development programs and encourage more collaboration with scientists in academia, industry, NIH and other federal agencies.

Congress should also make conflict-of-interest restrictions more rational, to ensure that agency staff can get early access to external scientific expertise to evaluate emerging technologies. The FDA should be able to make greater use of scientific consultants as “Special Government Employees” to broaden the pool of qualified and approved advisers for the agency.

FDA scientists I have encountered do care deeply about patients and want to say “yes” to safe and effective new therapies. Regulatory approval is the only bridge between miracles in the laboratory and lifesaving treatments. Yet until FDA reviewers can be scientifically confident of the benefits and risks of a new technology, their duty is to stop it—and stop it they will.

Congress has an opportunity to improve all this as it considers renewing FDA user-fee legislation this year. The temptation will be to reauthorize the fees as quickly as possible and move on as usual for another five years. This would be a grave mistake. Reforms that allow the FDA to say “yes” to innovative therapies serve all the agency’s stakeholders, including current and future patients.

Otherwise we had better get used to the agency saying no by calling “time out” or, worse, “game over” for American companies developing new, vital technologies like regenerative medicine.

Dr. von Eschenbach, a former director of the National Cancer Institute and commissioner of the Food and Drug Administration from 2006 to 2009, is chairman of the Manhattan Institute’s Project FDA.

TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS – questions

In STEM CELLS IN THE NEWS on April 14, 2012 at 5:08 am

U+21E7.gifU+21E7.gifU+21E7.gifPlease rate this article 

Texas OKs experimental stem cell therapy limits

Friday, April 14, 2012

Will this move by Texas lead to a faster process of FDA approval and insurance coverage? - Boonie

 

My gut says: baby steps. They need to define the IRB process and make sure all the pieces of the machine work well. There are many factors which will unfold now.

Will other states fall after Texas like for medical marijuana?

Will Texas stand alone and all US stem cell companies open clinics there?

Will patients go to a clinic in Texas regulated by an IRB with zero experience over a treatment center outside the US with thousands of successes?

Can the FDA approval process be changed from clinical trial to produce drugs INTO a process oriented hybrid?

Will insurance cover it…ie will the American people, many whom think all stem cells are embryonic still so all stem cells = murder, many whom don’t know about the thousands of trials and tens of thousands patients treated, want to ‘foot the bill’ for these Texas treatments?

Many many questions.

Rome. Built. Not one day.

Baby steps…but a step in the right direction.

 

Related articles:

TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS – explained

In STEM CELLS IN THE NEWS on April 14, 2012 at 3:44 am

U+21E7.gifU+21E7.gifU+21E7.gifPlease rate this article 

Texas OKs experimental stem cell therapy limits

Friday, April 14, 2012

What this means:

1. This is not blind distribution of medicine with no control. The legislature demands full transparency & disclosure (not available to patients in clinical trials). In trials, patients have no idea what they are getting if anything! There is no patient, only guinea pigs.

2. There is oversight control by an Institutional Review Board. There will not be rampant, unchecked treatments or “growth motivated by cash only.”

Standard FDA clinical trials regulate only how DRUGS are brought to market. Adult stem cell therapies are not drugs, they are a procedure, a process, a protocol & must be treated differently in the courts & in practice like PRPs (which are legal. 2x standard?). It was way past time to end the idea: ‘the result of all medical intervention is a prescription drug.’ “Give a small boy a hammer, & he will find that everything he encounters needs pounding,” Texas is unburdened from the yoke of those blinded by a faith in a system that demands the mandatory adherence to “one size fits all,” “one size fits drugs,” “drugs fit all.”

Adult stem cells have a proven record of safety & efficacy in studies & trials around the world – thousands of them. American medical professionals are so Ameri-centric, they throw away or ignore anything conducted outside the USA…when our health system is ranked 37th in the world. This arrogance is suspect. “We’re 7th in literacy, 27th in math, 22nd in science, 49th in life expectancy,178 in infant mortality…” and the US throws away other country’s clinical trials & studies?  Perhaps we should throw away our entire medical system & start from scratch or at least start taking pointers from some other countries on how to improve our health care/medical system…countries who apparently do a better job at it than we do like ranked 27th to 36th: United  Arab  Emirates, Israel, Morocco, Canada, Finland, Australia, Chile, Denmark, Dominica and Costa Rica.

With our CLINICAL TRIAL system, a human patient is used as a Guinea pig & sacrificed for the patient of tomorrow, blindly & randomly given medications or not, given placebos or not or given nothing.  They are Guinea pigs by definition. There is no patient, there is no empowerment, there are no rights, there is no agenda for healing. The health of one patient is sacrificed today for the health of patients of tomorrow whom apparently have more value. Categorization of any human patient as dispensable, even in order to generate data for a drug treatment to be sold to a different patient tomorrow, is reprehensible.  Clinical trials = no agenda for healing today.

With ADULT STEM CELL TREATMENTS, a human is given a therapy today intended to heal that person today. That person. Their health, their survival, that patient is of paramount importance. Their life has value, today. Adult stem cell treatments are simply, a treatment today, paid for today, for a human today to heal today, live today and into tomorrow.

I guess you can be a Guinea Pig for future patients tomorrow or you can be an empowered patient for yourself today.  All this legislature does, is give you the choice. In the end, our choices are all we ever have.

Related articles:

TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS!!!

In STEM CELLS IN THE NEWS on April 13, 2012 at 1:11 pm

PERRY DID IT!!

I DON’T THINK I BELIEVE IT!!

IS IT POSSIBLE??

IS IT??

http://static3.itsuxtobefat.com/uploads/omg.jpg

Texas OKs experimental stem cell therapy limits

National / World News 1:46 p.m. Friday, April 13, 2012

The rules require patients to give their consent and a review board must approve the procedure before using adult stem cells.

Supporters say establishing formal rules will lead to more medical innovation. Critics warned that the rules don’t provide enough protection for patients and could lead to an explosion of doctors promoting unproven, expensive treatments.

Perry had his own stem cells injected into his back.

The Food and Drug Administration hasn’t approved using adult stem cells to help people heal from surgery, but experimentation is common. Some scientists tout the possible benefits, including treatment for heart disease, diabetes and some cancers.

Texas OKs experimental stem cell therapy limits  | ajc.com.

Related articles:

 

 

 

TEXAS – PERRY – STEM CELLS – NEW RULING

In STEM CELLS IN THE NEWS on April 13, 2012 at 4:10 am

Today (Friday) there is a very significant legislation ruling in Texas (prompted by Gov Perry and his use of stem cells during spinal fusion surgery) which if passed will allow the use of stem cell therapy in Texas under a few conditions. How will this effect the patients and the stem cell industry?


Back story:
MEDICAL BOARD Gives Early OK to Adult Stem Cell Rules – Part 1 April 9, 2012
http://repairstemcell.wordpress.com/2012/04/08/medical-board-gives-early-ok-to-adult-stem-cell-rules/
MEDICAL BOARD’s proposed stem-cell policy under fire – Part 2 April 9, 2012
http://repairstemcell.wordpress.com/2012/04/08/medical-boards-proposed-stem-cell-policy-under-fire-part-2/
DRIVING THE FDA DUNE BUGGY INTO THE STEM CELL OCEAN http://repairstemcell.wordpress.com/2012/04/04/driving-the-fda-dune-buggy-into-the-stem-cell-ocean/

This is by no means a political message and I neither endorse nor denounce Gov Perry but I do appreciate the incredible attention he has been able to focus on the benefits of adult stem cell therapies and if this legislature goes through, thousands of patients with no hope can be help with them.

Follow

Get every new post delivered to your Inbox.

Join 1,191 other followers

%d bloggers like this: