Clinics can’t retract stem cell treatments gone bad

Stem cell facelift comicYou can stop taking a pill or an injection treatment, but you can’t stop or retract stem cell treatments if there’s a bad side effect.

Unlike other kinds of medicines, once stem cells have been transplanted into patients, if something goes wrong you cannot stop the ‘treatment’. There’s no retraction possible because transplanted stem cells spread in the body and potentially integrate.

One of the striking things in the commercial stem cell arena in 2016 was the emergence of patient lawsuits against stem cell clinics including two proposed class action suits. These patients, and I count potentially now more than a dozen, allege a variety of harms ranging from tumors to blindness. The reason I mention this is that there appears to be huge potential for harm to patients from unapproved stem cell therapies. I know a lot of patients who would wish they could undo what the stem cell clinic did. It’s just not possible.Stem cell cartoon

Even in an appropriately regulated stem cell trial context, there’s no easy way to undo stem cell transplants. There has been talk for years about suicide genes to be inserted into stem cells to provide “a net” should something go awry with stem cell treatments, but it’s not clear how well these would work and stem cell clinics aren’t interested in that anyway.

Continue reading

Guide to September 12-13 FDA Stem Cell Meeting: Top 10 bullet points

The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees?

Who is likely to say what?

Stem cell cartoon

If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have a satirical cartoon from some time ago I drew imagining such a future.

Continue reading

Family Guy Cartoon Blows it on Stem Cells for Stroke

Do experimental treatments based on stem cells for stroke work and are they safe?

We simply do not know yet. There’s hope for the future, but more data are needed. I’m still hoping to do a post with an update on the science in the next month or so, but have been busy with grants and papers.

The animated show Family Guy weighed in on stem cells when main character Peter Griffin has a stroke that is then shown to be miraculously healed by a stem cell research facility of some kind that sure looks like a stem cell clinic.

Peter Griffin Stem Cells Stroke

In fact, the vague treatment of stem cells for stroke in the cartoon takes only 5 minutes we are told.

The character then asks, “why we aren’t funding this?”

It is possible that the show had good intentions in promoting stem cell research funding. However, the careless and inaccurate way it portrays stem cell treatments in general and in particular for stroke (which remain unproven and with sizable risks) is bad for the stem cell field and could put patients at risk.

Stem cells run amok: Jill Howlin’s satirical cartoon look

Jill Howlin’s drawings about science and policy have a unique, edgy style that packs a punch. I have invited her to weigh in here now and then with new illustrations that touch upon stem cell or other innovative biomedical matters.Jill Howlin stem cell treatment run amok

Jill’s new drawing today relates to some key stem cell issues such as clinical safety, choice of stem cells, homologous use, and more. You can read my post from this week on the myth that stem cells are homologous to all tissues.

Jill tells me that she put an Irish humour spin on this cartoon.

Also see her past cartoon on Donald Trump and pay walls in science and medicine. I have also drawn some of these science political cartoons as well for the blog myself (see examples here) at times, but I think Jill has a lot more talent.

You can follow Jill on Twitter.

You want sauerkraut on those stem cells? Defining the term “unlicensed” stem cell clinic

It may come as an annoyance or surprise to some folks in the non-compliant stem cell clinic world that there are laws, rules, and licensing involved in giving stem cell transplants to patients. (To be clear here, this post is focused on clinics transplanting propagated stem cell drug therapies that the FDA views as more than minimally manipulated (i.e. “351s”). Note added on March 21).

Hot dog cartWhen I refer to some of these dubious clinics as “unlicensed”, what do I mean?

To do some specific things with biologics such as stem cell products intended for clinical use, clinics must have an approved Biological License Application (BLA) from the FDA.

I would say it is reasonable to call clinics that are in this area and that do not have a BLA by the moniker “unlicensed”.

Disturbingly some of these clinics do not even know what a BLA is, while others know about it but intentionally blow it off.

A stem cell clinic may also be “unlicensed” if the practitioner there is unlicensed in one of the following ways:

  • Unlicensed in that state or country
  • Not a doctor at all
  • Has had his/her license revoked

I would also call a clinic “unlicensed” if it is treating patients with a stem cell drug (i.e. propagated or otherwise more than minimally manipulated stem cells) without an IND, Investigational New Drug, approval from the FDA.

However, the term “non-compliant” is just as apt.

Strangely, some people take offense at the idea that stem cell providers should have to have any kind of license at all!

What the heck?

If the cart down the street needs a license to sell me a hotdog (see picture above from Wikipedia) and the person cutting my hair needs a license and I need a license to drive my car, can anyone seriously argue that a guy injecting a billion stem cells IV into patients and charging each patient $20K a pop should not need licensing to run his stem cell clinic?

I recently did a stem cell political cartoon expressing my concerns about a deregulated stem cell future in which a stem cell clinic may need no more licensing than a coffee stand.