Burt Northwestern Stem Cell MS Trial Part 3: Funding, Patient Perspectives, & the Future

Today’s post is the last of a three-part series on the Burt stem cell trials at Northwestern. This piece is focused on funding and the future of the trial, and also includes perspectives from patients.

You can read Part 1 here and Part 2 here, which focused on issues related to potential encouragement of patient fundraising that unintentionally releases private information and on concerns over marketing of the ongoing trial as already known to be something like curative for MS. I’ve summarized my overall concerns in a flow chart below.

Stem cells for MS trial concerns

Trial funding

Should patients ever be required to scrape together one or two hundred thousand dollars to pay to get enrolled in any clinical trial? We have to keep in mind that in such trials patients have no guarantee of any benefits and could be harmed because the patients are research subjects. And what happens to the potentially large number of patients who cannot obtain that kind of money? They are excluded simply on that basis?

There may be certain instances where patients paying for a trial can be a responsible, positive thing. However, this is new territory overall for stem cell clinical research and there are sizable risks to this different kind of approach as compared to the past and to some other more traditional clinical experiments when sometimes patients were the ones receiving some kind of payment. As I discussed earlier in this series, extremely careful planning is needed to address bioethical and practical issues that may arise and anticipated risks to patients in such trials where patients have to contribute monetarily.

Some patients have said on the Internet that they are required to pay as much as $150,000 for participation in the Northwestern MS stem cell trial or in parallel off-study experimental administration of experimental stem cells.  If we estimate that about 100 patients have been required to pay (one way or another, such as themselves or via insurance or via online fundraising) on average $100,000 then that is in total $10 million for Northwestern University. Not a small sum, but clinical trials are expensive. If there have been 200 patients paying that much on average the total number could swell to $20 million. The big money involved here is just one more reason that NW and its IRB need to be extra careful in how it oversees this trial.

Do trial participants get any kind of discounted price on medical tests and procedures? Does the university cover all the research-specific (versus treatment) costs itself? How much does insurance pay for the average participant? How much does philanthropy by NW help the average patient? These same questions could be asked of any other trials that require patient payments as well, but there seems to be little if any information that I could find in the public domain on other stem cell IND-based trials that require large patient payments. Continue reading

Quick journal club on IPSC anti-aging paper: cool, but outstanding questions

A new Cell paper from Juan Carlos Izpisua Berlmonte’s group has made headlines about anti-aging across the globe because it suggests that the four core induced pluripotent stem cell (IPSC) factors use by Shinya Yamanaka to make IPSC can reverse aging. I’ve pasted the graphical abstract from the paper below and done a quick journal club style overview based on a quick skim of the paper.

ipsc-anti-aging-paper

Graphical abstract from Ocampo, et al Cell 2016

Some of the media headlines are rather dramatic on this story. For instance, in a story on it over at STAT the four Yamanaka factors (referred to as 4F: OCT4, SOX2, KLF4, and MYC) are referred to in the title on the new paper as “fountain-of-youth” molecules.

Yeah, I’d say that’s way over the top. But in contrast from my initial look at the paper, I don’t think the authors engaged in hype in the discussion of their results so kudos.

There are a number of reasons to be interested in this paper. It is novel and touches on some exciting areas of science, but I have some sizable questions about it too even just after a quick skim-read of it. A video from the Salk about the studies is below.

The paper used not only both surrogate molecular markers of aging such as DNA damage examined by staining, but also studies of both literal tissue aging and lifespan in mice as outcome measures (which is a lot of work and impressive). They found that pulses of the 4F condition seems to counteract aging, which is particularly evident in mutant mice that prematurely aging. These Progeria mice that received intermittent pulses of 4F exhibited significantly reduced speed of aging. More generally 4F mice also were able to recover from various kinds of injury better.

Just the right ‘Goldilocks’ amount of 4F is needed as the team found that persistent 4F outright kills the mice due to tumors. Since the 4F contains a powerful oncogene called MYC (one of my lab’s favorite proteins), another caveat longer term would be that even mice only given intermittent 4F might be more prone to tumors. However, the team did not report tumors in the intermittent 4F mice so far, which is encouraging.

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3 more FDA warning letters to stem cell cosmetics makers

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Resurgent Stem Cell Firming ActivatorThe FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics.

You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream.

Three new warning letters to stem cell cream makers popped up on the FDA site recently to makers Lavian Ltd, Sircuit Skin, and Annemarie Gianni Skin Care LLC.

Lavian markets something called Resurgent Stem Cell Firming Activator, which the FDA referred to as an unapproved drug based on website claims. This product is available all over the web and sells for more than $600/lb.

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FDA warning to stem cell cosmetics maker raises more questions about agency itself

The FDA has taken another action against a manufacturer of stem cell cosmetics in the form of anti-aging creams with a warning letter sent on April 20, 2016 to Crescent Health Center, Inc.

The FDA noted a number of issues in the warning letter that it termed “serious violations”, but the biggest issue was that the agency defined the anti-aging creams as unapproved drugs. The stem cell cosmetics in question are called “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” and “Ageless Derma Anti-Aging Intensive Skin Brightener Cream”. The letter was addressed to Dr. Farid A. Mostamand, CEO.

Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream

Screenshot from Amazon

In the past the FDA similarly warned L’Oreal/Lancome over its stem cell cosmetics products and another cream maker in 2014. However, as I noted recently you can get all kinds of similar “stem cell” cosmetic products with sky-high prices still these days at Nordstrom or elsewhere such as on E-bay or Amazon.

Update. I had originally written, “I found the Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream listed (image above), as offered by “Dr. Mostamand”, but now as of the same evening I wrote this post, this product seems to have disappeared from Amazon. In fact there are no products listed anymore for “Dr. Mostamand” on Amazon that I can see.

The FDA noted a number of medical claims on the company’s websites including  the following domains: www.skinbeautymall.com, www.agelessderma.com, and www.drskinspa.com.

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Five simple updated ways to protect your stem cells to stay healthy & younger

Here’s an updated 2013 look at protecting one’s own existing stem cells.

Regenerative medicine is very exciting.

But what’s even better than regenerative medicine?

Preventative medicine.

If one can prevent a problem from occurring in the first place, it is far better than trying to treat it after the fact. Of course in many cases we do not know the causes of diseases so it is difficult to prevent them. However, many diseases are likely caused by problems with stem cells.

Therefore, stem cell research, including the work being done funded by CIRM, is likely to have enormous preventative medicine implications as well.

The average person can do some simple things to protect their and their family’s own population of stem cells and lower their risk of many diseases.

So what can we do?

Don’t get scared, get educated.

Below are some suggestions.

They may sound deceptively simple, but I think they can have a major impact. You’ll note that none of them involve paying thousands of dollars for stem cell infusions. I don’t believe that works. You’ll also note that I do not list taking so-called “stem cell supplements”. Why? Because they almost certainly don’t work.

The main thread running through all 5 suggestions is educating yourself to make little changes that protect your existing stem cells. In turn the stem cells will likely have a better chance to take care of you fixing your injuries, helping you get over illness, and possibly helping you stay a bit younger.

I discuss these kinds of steps for protecting your stem cells and a novel theory of aging based on stem cells in my new book.

1) Lower your risk of skin cancer by protecting your skin stem cells. Become an educated user of sunscreens and about sun exposure. Their use is complex and in fact may be harmful if misused as most of us do.

It seems likely that much or all of skin cancer is the result of UV radiation from the sun damaging skin stem cells. However, it is also recently becoming clear that sunscreens have many potential problems. Their labeling is confusing and it is often unclear just how much protection they afford the user. It is also very concerning that there is growing evidence that some sunscreens may actually increase your risk of cancer either through the chemicals they contain such as Vitamin A derivatives and/or through giving people a false sense of security that they are protected if they don’t burn. There is an excellent article on this including thoughts from several physicians here in the NY Times. It’s important to note that a small amount of sunlight is likely to be healthy by producing Vitamin D in your skin. As it turns out, the majority of people have Vitamin D deficiencies. There has been some very exciting research, including on stem cells, on the importance of Vitamin D for our health. It may be particularly important for preventing cancer, but also other diseases. Whereas research on Vitamins A and E have been disappointing for showing health benefits, research on Vitamin D has proven its benefits and many new studies of Vitamin D are underway. In any case, the best protection from skin cancer is shade or if you have to be out in the sun, clothing. Do not let sunscreen increase your sun exposure dramatically or its use will backfire.

2) Minimize your exposure to plastics, protect all your stem cells. The plastics industry has seen a revolution over the last few decades in their product base such that our lives are filled with products made of or stored in plastics. Unfortunately, the levels of plastics and plastic-related chemicals in our bodies have shot up in parallel. The safety of these plastics is largely unknown, however there is growing evidence that some of the chemicals in the plastics such as Bisphenol-A (see Keep Your Stem Cells Away From BPA)  are dangerous and may increase your risk of cancer. Again, the likely target is stem cells. The plastics industry so far has been very successful in blocking regulation of their products, but that does not mean they are safe and the FDA has expressed growing concern about this issue and Bisphenol-A.

Below left is my guides to plastic use.

Plastics Guide

Some super simple ways to protect yourself include the following: NEVER microwave your food in a plastic container of any kind even if it says it is microwave safe (don’t be deceived–there is no such thing as a microwave safe plastic container), if you want to be really safe, never store your food in a container made of plastic, do not drink water out of plastic bottles, do not let your very young children play with/chew on plastic toys, especially those containing Bisphenol-A. Not only will these steps lower your risk of disease, you also won’t be contributing to the massive pollution of our environment by plastic such as the Texas-sized whirlpool of plastic in the ocean that contains an estimated billion pounds of trash, most of it plastic. Apparently there is another whirlpool of plastic in the Pacific Ocean as well.

We don’t want even microscopic whirlpools or plastic or plastic-related chemicals floating around in us or literally inside of our stem cells, right?

3.) Don’t reprogram your stem cells into cancer: Eat food, not chemicals. A growing trend throughout the world is the consumption of food-like products that are not really food. It’s important to take the simple step of knowing what you are putting in your body. Any packaged food is something you should learn more about before eating. Read the label. Are there many ingredients that sound like chemicals and that you do not know what they are? If so, that’s a bad sign. If they sound like artificial chemicals, that’s what they are. They are not food. The safety of food additives is questionable. Many of these chemicals have no place in our digestive tracks or our bodies. They may alter the epigenetic programming of our stem cells or damage stem cells. As the reprogramming field advances, we are learning the power of chemicals to replace genetic changes in producing iPS cells from skin cells to perhaps one day be used in regenerative medicine. However, chemicals also have the potential to reprogram your normal healthy stem cells into cancer cells.

4.) Exercise your stem cells. No I don’t mean take them out for a walk like a pet. Growing research (see for example here and here) suggests that exercising regularly slows aging and may help maintain a healthier, larger population of stem cells, particularly in the brain, but also in other organs. Exercise is the true fountain of youth and much of its benefit likely stems from stem cells. Of course when we don’t feel well, it’s much harder to exercise, but the point is to do one’s best. Even something as simple as a short walk, gardening, taking the stairs if done almost every day could be helpful.

5) Minimize your exposure to radiation, protecting your stem cells from DNA damage. We have learned in the last couple years or so that many medical tests using radiation have not been administered properly, often exposing patients to enormous doses of radiation. If you need a medical test or are contemplating something like a whole body scan, don’t rush into it if at all possible. Learn as much as you can about the dose of radiation you will receive and the safety protocols in place by those administering the test. Some CT scans, even when performed properly which is what happens almost 100% of the time, deliver the equivalent of up to 500 chest x-rays of radiation.