Breaking: New FDA Draft Guidance Views Fat Stem Cells As Drugs

FDAWith a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US.

There are more than 100 such American clinics that are selling stem cell “treatments” to patients and almost all of them use non-FDA approved stem cell products isolated from fat tissue.

The clinics have argued that they do not need FDA approval and just keep on raking in big profits from vulnerable patients.

They have claimed no need for FDA approval because they believe that the stem cells isolated from fat tissue that they use are not “drugs” because they are “not more than minimally manipulated.” In English that means that the clinics are arguing that the purified fat stem cells are basically the same as overall fat tissue.

To me that doesn’t make any sense.

A groundbreaking draft guidance statement today by the FDA for the first time sends the message to the clinics that the clinics are very likely wrong and could be subject to future regulatory action.

It is important to point out that this FDA statement that mentions fat stem cells is “draft guidance” meaning that it is not yet finalized, but make no mistake that this is the clearest snapshot to date on the FDA’s views on fat stem cells and it is unlikely to fundamentally change during the comment period.

The bottom line is that fat stem cells are viewed by the FDA as drugs that must be vetted and approved prior to use by physicians and clinics.  It also reinforces statements from draft guidance issued earlier in October that narrowed exceptions to the same-day surgical procedure guidance for use of biological materials such as stem cells.

In the new document today, the FDA even sets out isolation of fat stem cells as an example of more than minimal manipulation (emphasis mine):

Example 10-1: Original relevant characteristics of adipose tissue, a structural tissue, to pad and cushion against shocks generally include its bulk and lipid storage capacity. A manufacturer recovers adipose tissue by tumescent liposuction and processes the adipose tissue to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells. The HCT/P generally is considered more than minimally manipulated because the processing breaks down and eliminates the structural components that provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement.

A tissue product that is “more than minimally manipulated” again is a biological drug requiring prior FDA approval before use in patients.

I agree with this new FDA draft guidance because again fat stem cells are to my mind (as a cell biologist who has been studying cells for more than two decades) different than fat tissue. Fat stem cells constitute a biological drug that should be approved by the FDA in advance as well as tested in clinical trials before experimental, for-profit use on patients.

Another issue that applies is “homologous use” meaning that a product such as fat stem cells can only be used in a similar fashion or it is automatically a drug. For example, fat stem cells in theory could only be used therapeutically in a manner related to fat tissue-related health problems. The clinics today use fat stem cells to treat pretty much every condition from head-to-toe, which is clearly non-homologous use.

You can make a comment to the FDA on this draft guidance by following the instructions below pasted from the FDA guidance page.

How to make a positive difference? I encourage you to make a quick comment supporting the definition of fat stem cells as more than minimally manipulated and hence biological drugs. It is the safest thing for patients and the best way to go for the stem cell and regenerative medicine field.

Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

Super Cells exhibit and why we bother with public outreach

Willemse_Lisa2013Guest post by Lisa Willemse

Last month, on this blog, Paul wrote an article about loopholes in the clinicaltrials.gov database that allows for-profit companies to advertise their “therapies” under the guise of a registered clinical trial. This is a real concern for our community, especially those among us who have recommended the clinicaltrials database as a source of information for patients who are considering an experimental treatment and wish to better understand the difference between a clinical trial and an unproven, cash-based therapy.

Those of us more familiar with the language and methods used by the for-profit clinics may recognize their tactics hidden among the registered trials database, but given the credibility and trust the database has had up until now, it is reasonable to assume that a good number of physicians, patients and their caregivers may think that all the procedures listed therein are legitimate.

Super CellsBefore we get too far: This is not a blog about the clinicaltrials database, rather it’s about science communications, specifically, Super Cells, a science exhibit for kids.

It might seem odd to think about outreach to children in the context of the dangers of unproven therapies. After all, I don’t imagine too many 12-year olds are googling stem cell therapies. But jump ahead five or 10 or even 20 years, and who’s to say what they will be looking for? Like the public of today, they will need the tools enable them to winnow out the nuances in what they read online and, ultimately, make informed choices about their health and welfare. We can start with basic understanding of the science.

Recent surveys conducted in Germany and the UK (here and here) (US data comes from a meta analysis, not a single, directed survey; and recent Canadian data is not available) suggest that awareness of “stem cells” is quite high among the general public, however, there is little understanding of exactly what it means. Closing the gap in understanding is therefore a high priority.

No single communications strategy, on its own, will achieve this. We all know we’re living in a world of fragmented media, and in such a world, you need many channels of approach.

There are several initiatives available (including specific websites, resources and information portals) to directly address concerns the research community has about unproven therapies. Blogs such as this one, the one I co-edit, and others (examples here and here) also deal with this issue with regularity. When it comes to broad basic information about stem cells, there are also plenty of excellent resources to choose from: videos (feature length, short and in between), webinars and events, science cafés, and a myriad of teaching tools, to name a few. Everything helps, although, given that much of it is self-directed, it requires a pre-existing interest in the topic, and thus, may exclude audiences that do not seek out scientific content.

Kids, particularly school-aged ones, are a bit of a different story. While I’ve suggested that they are unlikely to seek out more complicated science on their own (unless it’s cleverly wrapped up in a game or a TV program, for example), they do engage with science topics in two important ways: through science curricula and enhanced science programming in schools, such as individual or group projects and organized trips to science centres, museums and other science events.

It was with these school trips and family vacations (i.e. a younger, lay audience) in mind that the Stem Cell Network embarked on the production of Super Cells: The Power of Stem Cells, a 1600 square foot (150m2) exhibit dedicated solely to stem cells. We weren’t alone in our interest in bringing this topic to life for students: CIRM, CCRM and the Cell Therapy Catapult came on board as partners and we received significant in-kind contributions from EuroStemCell.

Preliminary visits with children in schools and in science museums formed the basis for the content contained in the exhibit, which uses a variety of hands-on, interactive modules to reveal the important role stem cells play, not just in our early development, but in our daily lives and in our future health. When we spoke to them, kids wanted to know things like how a lizard grows a new tail, where does disease comes from, how we grow and heal and what is a stem cell.

Animations, touch-screen displays, videos and images are integral to the presentation of science, since this is what draws viewers in. Each of the four sections has a specific area of focus, whether introducing the concept of a cell, to explaining how stem cells form the body and continue to help us grow and heal, to showing where stem cells live in the body’s tissues and organs. One of the largest sections is a small replica of a lab, where visitors can see how stem cell research is done, what challenges exist, and can try their luck with a game that asks them to grow photoreceptors from retinal stem cells and implant the new cells into an eye, in hopes of giving sight to a person who has gone blind.

Super Cells was built by an award-winning team at the Museum of Nature and Science in Sherbrooke, Quebec, and was officially launched there on September 25, 2014. Next spring, it will travel to Europe for an installation at the Centre for Life in Newcastle and will return to Canada for the fall of 2015 before spending all of 2016 at various locations in California.

While a collection of interactive games, modules and supporting text is a long jump from helping people discern bogus from real therapies, it is an important first step in helping our next generation understand a little bit more about science and the incredible powers hidden inside their body.

Lisa Willemse is Director of Communications at Stem Cell Network

 

Stem Cell Blog of the Year 2013: Signals Blog by Stem Cell Network/CCRM

Stem cell blogs are an increasingly important part of the stem cell field.

Today in 2013 it is a far different world for stem cell blogs than when I first had my idea to have a blog in 2009 and when I got it going in early 2010. It was pretty darn lonely back then. Most of the other stem cell bloggers out there at that time were either opponents of stem cell research or promoters of dubious clinics who get a cut for recruiting patients.

Now there are relatively more positive blogs and the quality keeps going way up. Last year the winner as blog of the year was stemcellassays.com by Alexey Bersenev, which remains an incredibly helpful and positive resource this year as well.

What was the best blog of 2013?

This year my pick is the Signals Blog  by the Stem Cell Network & CCRM in Canada. If you haven’t checked it out, I highly recommend it.

Signals Blog

It was a tough choice to pick just one blog of the year as several blogs in 2013 shined including the runner up for this year, the excellent CIRM Research Blog, which continues to add more frequent & as always thought-provoking posts by its team.

Part of the reason I chose the Signals Blog this year as the best is its incredible frequency of posting and quality of blogging as well as the global diversity of stem cell related topics that it covers. The folks at the Stem Cell Network and the Centre for Commercialization of Regenerative Medicine (CCRM) outdid themselves with their blog this year.

Other notable stem cell blogs include:

Did I miss some? Let me know in the comments and I may add to the list above.

StemCellShorts Videos Cool & Powerful Tools for Stem Cell Outreach

Ben Paylor has made some awesome animated stem cell videos for educational outreach via his project called StemCellShorts supported in part by the Stem Cell Network.

These videos are narrated by true scholars of the field and are a very effective means for teaching about stem cells. I really enjoyed them and highly recommend them to you

The three in this post are out in the public domain now.

Stayed tuned here as there will be more to come in the way of StemCellShorts videos in 2014 that should be just as great!