FDA warp speed RMAT approval nukes stem cell clinic excuses

Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality.

warp speed

Flickr image marked for re-use

Stem cell clinics say that they only want to help people by providing stem cell therapies to patients in a speedier way that they claim getting FDA approval for a trial just doesn’t allow, but that doesn’t ring true. It never has and now even less so.

The new RMAT designation out there based on the 21st Century Cures Act whereby the FDA can rapidly accelerate truly promising stem cell therapies in clinical trials makes this stem cell clinic excuse of the need for speed seem even less based on common sense. For more on RMATs see this background post. With RMAT, one eligibility criterion for that designation is that the illness in question must be serious or life threatening. The clinics have generally indicated in the past that what they treat are serious conditions. Will the FDA see it that way? It’ll depend on the conditions in each case.

The FDA has already approved 4 RMATs in just a few months so they are not holding back. If you really have good, solid clinical data for a serious or life-threatening condition, then you should apply to the FDA for an RMAT and in theory you can have both speed and FDA approval for a trial to move quickly. This new situation makes that general stem cell clinic marketing pitch of needing to get supposedly truly promising stem cells to patients more quickly than the FDA system allows ring very hollow.

Clinical speed with no real data is kind of like driving a race car with no brakes.

And if you are a patient, before you consider getting any stem cell treatment you have a new additional “must-ask” question for the clinics out there: “Have you applied for an RMAT from the FDA?” or “Do you have RMAT approvals?” Also, see my stem cell treatment guide for patients where I list 10 more questions to ask and things to think about. Asking your primary care doctor who is not involved in the stem cell treatment for their professional take in advance on your consideration of a stem cell treatment is a good idea.

Fake stem cell news

fake-newsOne of my Top 20 Predictions for Stem Cells for 2017 was that we’d see more instances of fake stem cell news.

One type of stem cell fake news consists of promotional press releases that seek to recruit paying customers for unproven stem cell “treatments” based on made up or exaggerated claims about safety and efficacy or about the stem cell clinic’s credentials.

Another kind of fake stem cell news is more ideologically based and is mainly practiced by anti-embryonic stem cell (ESC) websites that have news-like items stating that ESCs have been proven not to work at all or to always cause tumors, while adult stem cells will save the world.

For whatever reason Google sometimes even includes both these types of bogus items in its news feed and I’m sure the same thing happens on Facebook. I’m going to be posting about instances of fake stem cell news over the course of this year.

Seen what you think might be stem cell fake news? Let me know.

The Niche top posts of 2016

stem cell fireworksWhat were the top posts here on The Niche for the past year? I’ve listed some of them below along with some posts from 2015 that remain highly read.

Some top 2016 posts

2015 and older posts that remain highly read every day

Top 20 Stem Cell Predictions for 2017

stem cell crystal ball

Stem cell crystal ball

Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions.

You can see below links to these predictions for past years, which sometimes seems rather far removed from today and in other cases strike me as strangely apropos of our times.

What will 2017 bring? Below are my top 20 predictions in no particular order except starting with a few hopeful visions for the coming year.

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TGIF top 10 weird stem cell posts: magic testicle soup, Kim Kardashian, zombies, & more

kardashian-vampire-facialAfter six and a half years blogging here, I’ve seen so much crazy stuff. Not all of it was even “bloggable” due to its nature.

For TGIF, here are 10 of the weirdest posts from this blog over the years.

Where’s the Beef? Reality Check on Stem Cell Test Tube Burger Baloney

ZombieStem cells in my Pepsi? A new crazy stem cell myth

Please pass on bull testicles Soup No. 5 & on stem cell Soup No. 7

Haruko Obokata 小保方 晴子-like Game Character Conducts ‘Dangerous Research’

Stem cells sold for better sex part 2: bigger & better penis?

Strangest stem cell event of 2012: Moriguchi’s fake iPS cell transplants

Testimony in shocking supermodel stem cell fraud case: “I lied to patients”

Kim Kardashian vampire facelift: stem cells in there?Soup No.5

Beyond zombies: reviving dead people with stem cells & lasers?

Stranger than fiction: the electric stem cell bra for breast enlargement