Stem Cell Gold Rush

California’s landmark stem cell research program made headlines nationally, but what is the latest story behind the science? QUEST investigates the potential for medical breakthroughs in the next decade and how the Bay Area is leading the way. Watch this video to learn more: Stem Cell Gold Rush

Book Review – The Roadmap to 100

By Jordan Lite Mar 22nd 2010 12:53PM
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middle-aged men swimmingThink your genes have sealed your fate? Not so fast: While heredity holds some sway over how long you live, there is plenty you can do to improve your chances, says Walter M. Bortz II, M.D., co-author of “The Roadmap to 100: the Breakthrough Science of Living a Long and Healthy Life.” Here are 10 questions to ask your doctor about how to live longer.

1. Do I have any control over my longevity? Absolutely. Most of what people think of as aging is really inactivity. The important differentiation is that you can do something about disuse, but you can’t do anything about aging.

Aging is not a disease. You can’t cure it, so you need a whole different way of thinking about it. I don’t think doctors have much to do with it. They want to fix things. Aging is not something to be fixed. It’s an energy issue, not a fix-it issue.

2. What are the proven strategies for a longer life?
Long-living populations certainly do not have high-tech medicine. The recent Blue Zones series by National Geographic found commonalities between populations with high numbers of people over 90: exercising, relaxing, having spirituality or a belief system, having a purpose in life, prioritizing family, belonging to a community, drinking red wine in moderation, eating plant-based foods and stopping eating when 80 percent full.

It’s much more of a lifestyle issue. A recent study by Harvard University doctors found that smoking, diabetes, obesity and high blood pressure were all associated with men dying before the age of 90, while exercising regularly — enough to break a sweat — was linked to living to 90 or older. Diabetes and obesity are largely linked to eating habits. And those men were in better physical and emotional shape than the ones who lived fewer years.

3. How big a role does genetics play in my lifespan? A number of us have done studies with twins. If genes were the master determinant, twins would die on the same day of the same disease. Genetics determine about 15 percent of the difference in longevity between people. So genes matter a little bit but not very much. It ain’t the cards you’re dealt; it’s how you play the hand.

4. What eating habits are associated with long life? It’s the standard high plant food, low animal fat emphasis. Mediterranean diets that are high in fruits, vegetables, fish and olive oil have been shown to be better for lifespan than, say, meat-heavy diets. The National Cancer Institute found that people who eat lots of red and processed meat have a higher risk of death, especially from heart disease and cancer, than those who eat little meat.

5. Are there drugs or supplements I can take to live longer? There’s no way you can go down to Walgreens and buy a “don’t get old” miracle pill. Nobody has yet shown that antioxidants and vitamins do any good at all.

6. How can exercise help me live longer? Exercising turns on the good genes and turns off the bad ones. Research at the University of South Carolina found that men could reduce their risk of dying by an estimated 37 percent and women by 50 percent over an eight-year period just by becoming physically active.

The President’s Council of Physical Fitness recommends at least two and a half hours a week of moderate-intensity exercise, such as brisk walking or gardening. The most important step is the first step. Every successive step after that further helps.

7. Does too much stress shave years off my lifespan? Of course. The Greeks taught, “Everything in moderation.” When you’re stressed, you’re overexpressing your anxiety. Not only has research linked stress to worse immunity, but studies have found that people who experience prolonged stress die sooner than those who aren’t chronically anxious.

8. Will having sex help me live longer? Sex is good for longevity, too. A study in Wales showed that people who had good sex lived longer. Middle-aged men who had two or more orgasms a week were less than half as likely to die over the 10 years they were followed than other men. And a study at Duke University showed that more sex for men and better sex for women were associated with longer lives. Why would that be? It’s part of the quality of life.

9. What do relationships have to do with longevity? Obviously, people live longer if they’re in a social environment. A study that followed people 65 and up for 13 years found that those who volunteered, got together with friends and even ran errands saw just as much benefit to their lifespan as those who exercised. Other research has found that people who are socially isolated are less able to fight infection. When you stop being engaged, you withdraw from work, you withdraw from sex, you withdraw from reading magazines, and when you do that, your body goes into an inactive, boredom mode and you don’t do well.

10. Even if I manage to live a long time, am I doomed to lose my memory as I get older?
There have been studies on supercentenarians, people over 110. Madame Jeanne Calment — the oldest living woman on record, who lived to 122 — didn’t have dementia. So if people over 110 don’t have dementia, does that mean it’s not an inevitable consequence? Certainly the incidence goes up: More than 5 million Americans 65 and older have Alzheimer’s, and by 2050, anywhere from 11 to 16 million Americans will, according to the Alzheimer’s Association. However, it’s not necessarily inevitable.

Your brain is a muscle, and it behaves just like one when used appropriately. Exercise increases blood flow to the brain, and a study published last year by Columbia University doctors who followed around 2,000 elderly people for 14 years found that those who were physically active had a 29 to 50 percent lower risk of developing Alzheimer’s disease than those who didn’t move around, depending on how active they were. Some scientists believe having more education lowers your risk, and reading the newspaper regularly has been associated with a reduced risk of Alzheimer’s. Writing letters to the editor, running for public office, having a pet and reading good magazines all are ways of exercising your brain.

FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial

SAN DIEGO, California (April 20, 2009) Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug (IND) for a clinical trial for ischemic stroke using Stemedica’s high potency proprietary allogeneic stem cells (adult human).

“The FDA acceptance of our IND application and the clinical protocol for usage of allogeneic mesenchymal bone marrow-derived stem cells in subjects with ischemic stroke is an important milestone for Stemedica in its development program,” said Nikolai Tankovich, MD, PhD, Stemedica?s President and Chief Medical Officer. “Currently, patients suffering from ischemic stroke have very limited treatment options. We hope that bringing this novel option to the medical community will help to alleviate the burden of a serious and disabling disease and will be valuable for both patients and their family members.”

The IND application approval allows Stemedica to initiate a planned clinical trial at medical centers within the United States. The clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living.
“This approval, along with the licensing of our cGMP manufacturing facility, are two important breakthroughs in our company?s evolution,? said Maynard Howe, PhD, Stemedica?s Vice Chairman & CEO.? “It is a testament to the professionalism and focused persistence of our team.

Stemedica is licensed by the State of California?s Department of Public Health, Food and Drug Branch to manufacture stem cells, drugs and biologic products for human clinical trials. The Company is compliant with both California law and the Code of Federal Regulations.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

To view this press release and others on Stemedica?s website, please click link below:

https://stemedica.com/info/042010-FDA-Approves-Stemedica-IND-for-Ischemic-Stroke-Clinical-Trial.asp

Dr. Centeno in Colorado Skirts FDA To Provide Stem Cell Therapy

Dr. Centeno
Dr. Centeno is offering stem cell therapy in Colorado

Dr. Centeno is offering stem cell therapies for orthopedic damage with remarkable results. Is this the future of stem cells in the US?

The FDA has yet to approve stem cell therapies for general use in medicine, but that hasn?t stopped doctors in Colorado from providing them anyway. Chris Centeno and John Schultz have boldly formed Regenerative Sciences Inc. in Broomfield, Colorado. RSI provides its patients with the Regenexx procedure, an adult stem cell transplant that uses your own cells (autologous) to treat joint injuries and bone damage. There?s no surgery needed. A needle extracts bone marrow, RSI isolates the stem cells and cultures them in your own blood, and then these cells are injected into the area where they are needed. They?ve treated 348+ patients with 800+ injections and show no signs of slowing down. According to RSI?s own surveys, 89% of their knee patients showed marked improvement, as did 75% of their hip patients! Within months some patients can walk or run in ways they haven?t been able to in years. We?ve seen these kinds of results from stem cell treatments before, but only in horses and dogs. That?s because human stem cell therapies like this one aren?t approved by the FDA. How can Centeno and Schultz flaunt the lack of federal approval? They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado, and as such is no more regulated by the FDA than it would be by the FAA or the Department of Motor Vehicles. For hundreds of patients, he and his team are providing a remarkable hope. They?ve brought lab-cultured medical stem cell therapies to the US. Finally.

Stem cells have been a focal point for hype and hope for years now. Besides healing horses and dogs, they have promising effects on diabetes, corneal blindness, even HIV. It?s pretty clear that they?re also the future of organ transplants. Just the news of a stem cell related development or patent will cause a biotech company?s stocks to soar. The FDA, which regulates all interstate drug sales and related clinical trials is not trying to keep Americans from these ?miraculous? cures, it?s simply trying to make sure they are safe first. Apparently, that?s taking too long. Medical tourism agencies are starting to cater to those seeking stem cell treatments. Whether or not they are ready for widespread medical use, stem cell therapies are in high demand, not just in the US but around the world. It?s no longer a question of when we will have access to these treatments, it?s a question of how.

Stem cell orthopedic treatment
A severely damaged knee healed to a remarkable degree.

A severely damaged knee healed to a remarkable degree. Must be stem cells. RSI is offering adult stem cell therapies in the US. That’s an important first, but what will happen without FDA approval?
Patient?s interested in the Regenexx procedure face what seems to be a fairly standard experience for autologous stem cell transplants. It takes 20-40 minutes to extract the cells from hip bone marrow with limited anesthesia, and blood is also taken. Over a month RSI?s lab will isolate mesenchymal (multipotent) adult stem cells and multiply them until they have 1 to 10 million. Typically, a patient will receive an injection into the treated area once a month for three months. Positive results are sometimes seen quickly (in 1 to 3 months) but will hopefully develop within 6 to 9 months. Importantly, there?s no down time as a result of the procedure. Patients can leave the clinic and go home after each injection.? A round of Regenexx (extraction, cultivation,? and 3 injections) costs $7000-$8500. Those who produce exceptional numbers of stem cells can use subsequent injections (even in other parts of the body) for around $3500. Most insurances will not cover the treatment.

The fact that RSI isolates and cultures (multiplies) the cells is a big difference from other clinics that offer stem cell therapies. That process allows the lab to create enough mesenchymal stem cells? to really have an effect on the area in which they are injected. Many clinics around the world will take blood, marrow, or tissue and then spin out the stem cells in a centrifuge, injecting them back in on the same day. That style? of therapy could possibly be effective, but it is far less likely than with a dose of millions of multipotent stem cells. There are several doctors around the US that will provide such ?single-visit? stem cell therapies, but RSI is offers the lab cultured mesenchymal therapy in the US. Dr. Centeno has confirmed that he?s the only one, that he knows of, openly using this particular procedure in the US.

In the past, many have been very skeptical of stem cell treatment centers in other countries. First, let?s look at the success RSI is selling. Autologous transplants are offered in the hands, hips, knees, shoulders, back (non-spinal cord injury), ankles, and bone fractures. For each of these procedures you can find many ardent and exceptionally encouraging patient testimonials on their website, or their YouTube channel, along with a flood of supportive media.

Overall, RSI is claiming around 80% patient satisfaction according to its own surveys. That?s incredible, especially when you see some of their patients walking and running again on joints that have experienced years of chronic damage. It also seems Centeno and Schultz have the documented evidence to back up the claims for Regenexx?s success. RSI provides case studies for each of its treatments as well as published scientific research. According to my conversation with Centeno, RSI is currently working on a comprehensive statistical analysis of their more popular treatments so they can publish quantitative results in a peer review journal. In other words, they?ll soon publish the hard numbers ? X% of patients feel Y% better Z months after the procedure.

Importantly, RSI seems to be upfront with patients about the limits of their own technique. The website FAQ clearly states that not all results will be like the testimonials, and they even have a dedicated page explaining that stem cell therapies won?t work for everyone. Furthermore, RSI has published the largest study of risks and complications associated with stem cell treatments yet produced in the US (N=227). That paper demonstrates the very low harm associated with stem cell therapies ? much lower than the alternative surgery(published in Current Stem Cell Research & Therapy). Centeno claims that if we?re really worried that autologous stem cell therapies are going to hurt someone, this paper pretty much shows they won?t.

The concerns most people have with RSI are not medical, they?re political. Many applaud Centeno and Schultz for supplying the public with the cutting edge technology they demand, but worry about the manner in which it has been accomplished. Skirting FDA approval for a technique through the arguments they use opens the gate to a host of problems. If RSI can provide Regenexx because it is a doctor?s procedure not involved in interstate commerce, does that mean someone else can do the same for another treatment? What are the limits of such procedures? How does a patient know if a doctor?s therapy is safe, or effective, if it hasn?t undergone peer review and government inspection?

Doctors and surgeons are developing new procedures all the time. Surgeons will often create new devices for their own use in surgery, doctors routinely try out new dosing regimes, or therapies on their patients. This is part of the medical profession.

Still, it?s possible that even though RSI is doing what many other doctors routinely do (develop a new therapy for use in their own practice) that the federal government could try to bring them to court. The FDA seems to have taken the stance that all stem cells (whether used autologously or not) are drugs. As such, they would need FDA approval, and would likely only be developed by large pharmaceutical companies.

According to Lee Buckler of Cell Therapy Blog, Centeno?s already received a warning letter from the FDA. Centeno clarified that this is actually an ?untitled letter? which has no bearing on regulation. He pointed me to this explanation on untitled letters. RSI has faced concerns from the New York Department of Health, and went so far as to pursue a provisional license, even though they are no where near NY state. Clearly RSI is hoping to avoid bureaucratic problems or at least be very prepared for them if they do arise.? Perhaps with enough positive results they can avoid legal battles and even convince insurance companies to cover Regenexx.

Hopefully so. Just look as these results. They?re pretty damn amazing. If you accept the success rates, and the possibilities for long term healing?many people need this.

Centeno says he is working with others to provide the framework through which many more patients could receive mesenchymal stem cell therapies. He?s on the board of the International Cell Medicine Society (ICMS) which is working to track stem cell therapy patients through a registry, as well as certify stem cell clinics for practice. Through conferences and seminars, doctors are trained in IVF to work in fertility clinics. Centeno explained to me that a similar practice could instruct and track physicians interested in providing lab cultured autologous stem cell therapies. In other words, the technique used by RSI could become a regularly seen procedure in specialty clinics across the country. That may mean more patients could have access to stem cells soon.

FDA approval is slow, but it?s coming. Athersys has a patent for a stem cell derived drug, other companies have therapies in clinical trials. Those treatments will be here some day. In the meantime, RSI is filling in the gap. Their work may even catch on as a trend. If largely successful, insurance companies may pay for it and the federal government may end up grandfathering Regenexx in at some point. It could happen. What?s certain is that the public demand for stem cell therapies is real, growing, and seemingly justified. When that sort of pressure for a technology exists nobody can keep it down.

There is no conclusive understanding of what the long term effects of stem cells treatments will be. We do not know if a stem cell treatment will be effective 5-10 years after it is administered, and we know of no large study that has conclusively reviewed patients for cancer, or any long term side effect 5-10 years after a stem cell injection. Part of what ICMS is trying to do (reviewing clinics, tracking patients results over the long term) may yield a better understanding in the future.

[Sources: Regenerative Sciences Inc, ABC 7 News in Denver, Lee Buckler , RSI Blog, Current Stem Cell Research & Therapy]

Tiny Worms Employed Test Life Extension Benefits of Herbal Medicines

ScienceDaily (Apr. 9, 2010) ? A team of researchers at the University of Maryland, Baltimore (UMB), writing in the science journal PLos ONE, have developed a biologic method to tease out which compounds from herbal medicines and medicinal herbal mixtures produce their reputed medicinal benefits such as life extension.

“This provides the first step to find, from all of the hundreds of compounds in herbs, which ones have potential for medicinal purposes. And you can do this very quickly and efficiently,” said co-author Laura Dosanjh, graduate student with the School of Pharmacy at UMB.

Science has not been very helpful in determining the efficacy of herbal medicines in the United States. The U.S. Food and Drug Administration, for example, has so far sided with science only once to approve an herb-based treatment with multiple active ingredients — an ointment for genital warts made from green tea leaves.

Now, using tiny worms that live only 20 days, the team sorted out which compounds found in two common Chinese herbal formulations showed most potential for their stated purpose: extending life expectancy.

Cinnamon and ginseng won, showing the most promise.

A team led by Yuan Luo PhD, MS, associate professor at the School, conducted a first-of-its- kind, “systematic evaluation” of a mixture of 10 herbs called Shi-Quan-Da-Bu-Tang (SQDB), reportedly effective for fatigue and energy; and an 11-herb formula called Huo Luo Xiao Ling Dan (HLXL) used as a the treatment of arthritic joint pain. Both mixtures are reputed to have benefits for healthy living and longevity in humans.

The researchers tested the mixtures, as well as each separate herb in them, on the laboratory worm model C. elegans. This particular worm?which biochemists often use as their ‘lab rat’? shares genes for aging and other traits with humans and other organisms.

Cinnamon bark (Cinnamomum cassia) from HLXL extended life span of the worms by 14.5 percent and cinnamon bark from SQDB extended the life 10.8 percent.

Ginseng root (Panax ginseng) from SQDB extended life span by 7.7 percent. Ginseng is not an ingredient in HLXL.

Significantly, cinnamon, ginseng, and SQDB also thinned out levels of hydrogen peroxide, which can destroy cells. They each also enhanced expression of small heat shock proteins, an indicator for cellular response to stress that plays an important role in maintenance of cell functions.

Furthermore, the life span-extending herbs appreciatively reduced in the expression in C. elegans of a toxicity factor, amyloid, which is a hallmark in the human brain of pathological development of Alzheimer’s disease.

In a 1998 national survey published in the Journal of American Medical Association, 49 percent of American adults said they had used herbal medicines within the previous year. However, proof of efficacy of herbal medicines, even their modes of action in the body, are extremely difficult challenges, said, Luo.

Herbal medicines are usually mixtures of herbs. That presents a severe challenge for the Food and Drug Administration to understand which compounds or combinations of compounds in the herbs are effective or not effective.

Said Dosanjh, “Because it’s very difficult to sort out so many herbs with so many constituents together, we needed to find a model. And there is a high level of [common genetic origins] with the nematode and humans.”

Luo added, “To isolate a single compound from an herb and test it for a medical condition, it often doesn’t work; not like the whole herb works.”

In recent years, scientists have learned to use C. elegans worm as a model system in for studying gene-environment interactions. In their experiments, the School of Pharmacy researchers first used “wild” C. elegans to screen the herbal mixtures and single herbs. They determined which herbs aided lifespan of the worms, then tested those herbs on well-characterized mutant worms. Each mutant was missing a single gene known for lifespan and/or stress resistance. C. elegans is valuable to science because its very short life cycle is suitable for conducting rapid experiments and between 60 to 80 percent of the 20,000 genes in C. elegans genome have similar origins to human genes. The genes are found consistently along the evolutionary paths including the worms and humans.

“The good news is that this is a way of testing to show the medicinal effect. It is now testable. We have statistical evidence for the first time in C. elegans for a multi-compound drug,” said Luo. “Most [scientists] are not using whole organisms for screening herbs. This is simple and clean, it is a system to look at specific genes. Now we have to further validate the human relevancy.

The School of Pharmacy study was published in the Feb. 2010 issue of PLoS ONE, Vo. 5.