Muddier stem cell waters: Stemedica teams up with UCSD doc?

stemedicaAn increasing trend in the stem cell arena is the teaming up of clinical partners with very different backgrounds and priorities. For instance, academic institutions are more often working together with for-profit stem cell clinics.

Another branch of this larger trend is the observation that some publicly traded stem cell biotechs such as Bioheart are increasingly turning to non-traditional means of raising cash such as through dubious stem cell training for doctors or other unexpected ventures.

It seems that in the past things were clearer in terms of who is compliant and who isn’t, who is following the spirit of FDA regs and who isn’t, and so forth.

The waters of the stem cell world are getting far muddier today as I predicted in my top 20 predictions for stem cells in 2015.

It’s a somewhat radioactive topic.

Why?

On the one hand such team efforts between academic and industry could be beneficial by speeding translation to patients, which is what the field needs. Cheers for that.

However, on the other hand for-profit stem cell clinics and academics do not always see eye to eye on how to do things, how to report findings, bioethics, patient consent, stem cell tourism, the proper way to handle public relations, and such.

Increasingly the commercialization of stem cells is making for strange bedfellows.

A good recent example is the work just announced that Stemedica indicates links it with UC San Diego (UC) for a stem cell trial for Alzheimer’s Disease:

“The study is sponsored by Stemedica International, S.A. and will start at the University of California, San Diego (UCSD) under Principle Investigator Douglas Galasko, M.D. and expand to other sites.”

You may recall Stemedica from the media frenzy over the last half a year on their role in the treatment of hockey legend Gordie Howe for stroke. In fact, Howe reportedly just got a second treatment from Stemedica and its partner Novastem in Mexico.

I found some aspects of the whole Howe-Stemedica story to be of great concern. For example, there is some question over whether the free treatment of Howe has led to stem cell tourism via more patients traveling to Mexico for non-FDA approved interventions. Football great Bart Starr may also have recently gotten such a treatment via Stemedica as well.

Of this new Alzheimer’s trial, Stemedica says in a PR:

“This study was approved based on the excellent safety profile of Stemedica’s cGMP-manufactured, hypoxically-grown stem cells and on solid pre-clinical data obtained by Stemedica International in cooperation with the École Polytechnique Fédérale de Lausanne of Switzerland and with a grant from the Swiss government,” said Lev Verkh, Ph.D. Stemedica’s Chief Regulatory & Clinical Development Officer. He continued “We are very proud of Stemedica’s clinical program under U.S. INDs for several indications including ischemic stroke, acute myocardial infarction, chronic heart failure, cutaneous photoaging and Alzheimer’s disease. At the study’s conclusion we will understand if our approach is efficacious versus placebo in subjects with Alzheimer’s-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.”

Now in principle some definite good could come from Stemedica working with academics and notably they have an FDA-approved IND for this, which is great. At the same time there may well be different priorities at work. I guess we’ll have to wait and see how it goes.

Other stem cell clinics raise more concerns and claim university affiliations too. For example, earlier this year we saw an odd stem cell clinic with their NIH-like name (National Institutes of Regenerative Medicine; NIRM) turn out to be affiliated with Cell Surgical Network, the largest chain of stem cell clinics in the US, which sells non-FDA approved “therapies”. NIRM had claimed a UCSD affiliation as well, but I no longer see that apparent on their website today.

Notably, Stemedica is different in some key ways from the dubious stem cell clinics we often talk about. They have a growing number of FDA-approved INDs and by all accounts I’ve heard through the grapevine that the stem cells that Stemedica produces are cGMP quality. Still their actions have raised concerns on some levels and the promotion of stem cell tourism to Mexico is a worry.

Overall, as the stem cell waters continue to muddy and with essentially zero apparent regulatory action by the FDA’s CBER specifically on stem cell clinics more broadly in the last couple years, I predict it will be increasingly difficult to know what is going on with any particular stem cell offering. Instead of getting clearer, things are getting grayer.

Book Excerpt: Stem Cells for Alzheimer’s Disease–Are We There yet?

Test for Alzheimer's DiseaseBelow is an excerpt focused on Alzheimer’s Disease from my new book on stem cells. Stem Cells: An Insider’s Guide, which is targeted to a broad audience of people interested in stem cells.

Alzheimer’s Disease (AD) is one of the most devastating illnesses. It destroys the brain, which shrinks over time (see image from Wikipedia at left) as the disease progresses.

The toll of AD is not only measured in hundreds of billions of dollars in health care costs and millions of deaths, but also in personal and family tragedy that comes with the severe loss of memory that accompanies it in loved ones.

Remarkably, scientists and doctors are getting better at predicting who has pre-clinical AD or who will ultimately get AD before patients are even symptomatic.

I have to wonder, though, would I want to know I will get AD if doctors have no treatment for it? I’m not sure.

At this time nobody really knows what causes AD. There are also no known convincing ways to treat or prevent it either. However, a number of avenues provide hope for the future and stem cells are one of the most interesting.

For example, the New York Times published an article about a relatively new clinical trial being conducted on a Columbian family that has a strong genetic predisposition to AD. Scientists are testing a treatment on this family using an antibody-based drug called Crenezumab. The drug is an antibody that has as its target the distinctive plaques that form in the AD brain even before the disease becomes clinically apparent. Many other drugs are being developed as well, but an overriding challenge is that, as mentioned above, we do not truly understand AD in the same way that we understand other diseases. Thus, further research is essential.

Another possible approach to treat AD is through stem cell-based regenerative medicine therapies. There are three key possible approaches to using stem cells to treat AD:

Regrow brain cells via cell therapy. One avenue is to use stem cells to regenerate or regrow diseased parts of the brain. This approach is what people most commonly think of when they conceive of treating AD with stem cells. The problem with this approach is that the architecture of the brain is physically integral to memory so even if we could grow a fresh, young part of the brain to replace one ravaged by AD, there would be no memories there. It would be like wiping the slate clean. In theory perhaps the person could make new memories going forward in life that could be remembered or they could be re-educated, but this is not what most people imagine as a successful treatment for AD.

Heal with immunomodulation. Another approach is to use stem cells such as MSCs not as rebuilding agents, but rather as healers of the existing brain tissue. In this way of thinking, MSC could heal rather than replace neurons for example. MSCs are akin to the natural doctors of the body. They could have anti-inflammatory and other powers that might ameliorate AD.

Drug delivery. A third concept is using stem cells such as MSCs as drug delivery agents. So for example, instead of giving Crenezumab or some other drug systemically, it is possible that stem cells could directly deliver a drug (e.g. one that targets plaques the way that Crenezumab does) within the brain from cell-to-cell far more effectively than a drug given systemically.

Some of these same kinds of approaches might be applicable to other diseases as well. However, all of them might be stymied to some degree by the potentially harsh or even cytotoxic environment of the AD brain, which may kill transplanted cells before they had a chance to do anything positive.

There are eight clinical trials listed in the national database for Alzheimer’s and stem cells.

Some of these same kinds of approaches might be applicable to other diseases as well.

For more info on using stem cells to treat other diseases here are links to posts in my disease focus series below.

Cancer Stem Cells: a new target

Disease Focus Series: Cancer

Disease Focus Series: HIV/AIDS

Disease Focus Series: Spinal Cord Injury

Disease Focus Series: Osteoarthritis research moving forward

Disease Focus Series: Parkinson’s Disease and promising new pre-clinical results from iPS cells

Disease Focus Series: a big week of exciting progress on Alzheimer’s Disease

Disease Focus Series: Huntington’s Disease, a major new finding

 

Stem Cells An Insider’s Guide: More on My New Book

Knoepfler Stem Cell Insiders BookIn about a month my new book, Stem Cells: An Insider’s Guide, should be available as an e-book from the publisher and from Amazon. It’s available for pre-order now at Amazon here. The “real” book (i.e. the one made of paper) should be available in September. The book costs $29. Any writers out there interested in doing a review please contact me.

As I’ve said before, I wrote this book in part because I wanted to learn more about stem cells and had gone looking in vain to find a stem cell book that had what I was looking for: opinions, cutting edge ideas, an easy reading style that at the same time wouldn’t insult one’s intelligence….I couldn’t find anything like that so I decided to try to write one.

I also enjoy humor in what I read and that was completely lacking in books on stem cells. It’s also generally lacking in science books overall. I tried to inject some humor into my book.

I thanked some people in the preface to my book who have been instrumental in helping me not only with the book, but also the past 3 years with advocacy and learning stem cell street smarts to be frank. My book is in one way an attempt to bottle up their collective wisdom and stir in some opinions of my own.

In the book I tried to call it like I see it in terms of key challenges and even secrets and misdeeds, but I also focus on the positive.

For example, I highlighted 4 stem cell biotech good citizens…any guesses on which four companies I called out for their positive actions?

I’ve also picked out 11 of the most important diseases/injuries and talk about how stem cells might work to treat or even cure them in the future:

  • Alzheimer’s Disease (AD)
  • Amyotrophic Lateral Sclerosis (ALS)
  • Arthritis
  • Autism
  • Cancer
  • Chronic Obstructive Pulmonary Disease (COPD)
  • HIV/AIDS
  • Huntington’s Disease
  • Multiple Sclerosis
  • Parkinson’s Disease (PD)
  • Spinal Cord Injury (SCI)

I also have an entire section on stem cell patient rights and another on great patient advocates.

I am excited as this book gets nearer to reality. I hope you will read it and find it interesting. Even if you do not agree with some of my opinions, I’m betting you’ll find it makes you think in new ways about stem cells. My primary goals to get people thinking and talking more about stem cells, to challenge them, and to provide an entertaining, even fun read.