A nation of stem cell miracles? CNN puff piece on clinic patient & Trump blows it

CelltexWould you believe in a stem cell miracle?

Sometimes the mainstream media stumbles in its coverage of the stem cell world and a recent CNN puff piece on a patient of stem cell clinic Celltex is a prime example of just how extreme this can get.

The CNN piece focuses on a Celltex patient who self-reports perceived big improvement after receiving the non-FDA approved offerings of the Texas stem cell clinic. Celltex is most famous for their number one customer and supporter Rick Perry, former Governor of Texas and now DOE Secretary in the Trump administration. For more background on Celltex including the warning letter it received from the FDA, you can see archived posts here.

CNN stem cells

Jacqueline Howard of CNN wrote about how the patient was invited to and attended Trump’s big speech before Congress recently. Howard mostly blew it on this article as she provided no background on the controversy involving Celltex, its past run in with the FDA, and how its offerings that it sells to patients are not FDA-approved as safe and effective. Minor details, right?

What about the fact that these kinds of treatments cost the average patient thousands of dollars, sometimes tens of thousands of dollars? Not important enough to mention?

And risks? No mention. The reality is that using adipose stem cells grown in a lab has sizable risks. Continue reading

Do stem cells for pain make any sense?

stem-cells-for-painDoes it make any sense scientifically or medically to use stem cells for pain?

I’m skeptical in most cases today.

The whole idea of stem cells for pain has been on my mind for a number of reasons.

For one thing, more stem cell clinics are marketing unproven stem cell therapies at a high price specifically for pain relief lately.

People are even having conferences on this concept. See the email ad I got yesterday on one such conference below

Is there any FDA-approved stem cell-based treatment for pain? Even one? Nope.

In Leigh Turner’s and my paper last year on stem cell clinics, we found in our data analysis that marketing of stem cells for pain was the 2nd most common claimed condition (see Figure 2B below). Even though this indication is unproven as safe or effective, clinics charge thousands and sometimes tens of thousands of dollars per intervention for this

Circling back, does it even make any sense scientifically that stem cells could relieve pain specifically?

How could this work if it can?

stem-cells-for-painA damaged tissue such as a knee-joint, if repaired by stem cells, could be less painful.

Maybe it could.

But again RCTs have not been done to prove this approach is safe and effective for repair, let alone pain relief.

In theory stem cells might be able to repair or replace dysfunctional nerves themselves leading to less pain, but most commercial offerings in this area aren’t using the right kind of stem cells. It’s not clear to me how, for instance, adipose or bone marrow stem cells could repair nerves. They are not programmed to do this.stem-cell-treatments-pain

Repairing a damaged spine with stem cells could also lead to less pain. But how do you get the right stem cells to the right place in the spine and have them do the right thing (and not the wrong thing) to fix the spine in such a way to reduce pain? Not simple, but possible.

There are more than 300 clinical trials for stem cells at least somehow related to pain. Hopefully some of these will provide clarity on this hot topic.

Nervana stem cell clinic: big ads in SacBee & big questions continue

The local stem cell clinic here in Sacramento, Nervana Stem Cell Centers, continues to advertise treatments in The Sacramento Bee and there continue to be big questions about this situation. I’ve blogged about Nervana before and you can see the archived posts here.

Nervana stem cell ad

Nervana must be spending big money on advertising because they have run many full-page ads in the Sac Bee in 2016. Those aren’t cheap. You can see the latest ad above in this morning’s paper.

The focus lately seems to be on marketing stem cells to treat neuropathy. One of the questions I have is whether there is evidence that using stem cells to treat neuropathy and other conditions such as arthritis is safe.

Is there any data showing it is effective?

Are consumers getting their money’s worth? These are expensive experimental treatments and stem cell treatment cost is a big issue in this arena today.

Is this OK with the FDA?

The fine print. As to that last question at least one past ad for this group seemed to suggest FDA compliance. However, in the fine print on today’s ad it says amongst other things, “the use of stem cells is not FDA approved for the treatment of the conditions that we treat and their use is investigational.” Some caution there from the clinic.

The word “investigational” there is also an interesting one as it raises the question again about whether the use of stem cells in this way would constitute the use of an “investigational drug” as the FDA would put it. If the answer is “yes”, then clinics should be getting FDA approval in advance.

It also says in an aspirational tone in the fine print, “However, we do believe in the healing power of stem cells and offer them to you in advance of any potential scientific discoveries that may prove their efficacy.”

Biomedical treatments should be, in my opinion, based on more than belief and should not be sold prior to proof.

Woman’s death after “no big deal” fat stem cell therapy: coroner investigating

An elderly woman in Australia reportedly died shortly after receiving a fat stem cell transplant.

Sheila Drysdale passed away hours after getting an adipose stem cell treatment a few days before Christmas in 2013. That death is now being investigated by the coroner there.Macquarie Stem Cells

Not only is this death in Sydney distressing in it of itself, but also it raises broader safety concerns across the globe including here in the U.S. because fat stem cell treatments of this kind are so widely administered. Most have not been approved by the various countries’ regulatory agencies including the FDA here in the U.S.

This kind of “liposuction stem-cell therapy” procedure is often marketed by stem cell clinics as safe and effective for a host of conditions.

The AAP article that reported the death provides more details:

“… in July 2013, Mr Drysdale heard an advertisement for Macquarie Stem Cells, whose celebrity patients included the late model Charlotte Dawson and cricket legend Geoff Lawson, and began investigating the possibility that stem-cell therapy could help his wife after reading about encouraging US case studies online.”

This part of the report also highlights how what goes on in the U.S. has global implications for patients and the stem cell field.

Continue reading

Stem cell clinic Nervana new ad claims no side effects & FDA OK

Stem cell clinics are spreading like wild-fire across the U.S.

Nervana ad march 28 A few months back the Sacramento area got a new stem cell clinic selling amniotic stem cell therapies for a variety of ills including most prominently arthritis and pain. This clinic is called Nervana Stem Cell Center.

I first noticed it via a huge ad in our local paper, The SacBee.

More recently, Nervana has advertised again in full-page spreads in the SacBee, but going by a different name: Lee Medical Group.

Yesterday, I saw another one of these ads for Lee Medical Group/Nervana (at left).

The SacBee must be collecting huge amounts of money for these ads, but should they even be running them? In my view, this stem cell clinic is selling unproven stem cell-based hope that could put patients at a variety of risks without published scientific data to back up that it works.

The clinic ads are making specific medical and regulatory claims too that seem dubious to me. For instance, if you look at the image at right of a specific part of the ad it says, “no known side effects”. Nervana ad medical claim Of course any treatment could have side effects and that includes something as simple as aspirin. Stem cell therapies are complicated and can have side effects that are serious.

It’s hard to even find out who the doctors are at this clinic even by calling them, looking at the ads, or going to their website. It seems most likely that the physicians are Drs. Tushar Goradia and Clarence Lee, but I’m not 100% sure. If this is not correct, I hope that Nervana will let me know and fill the community in on what is going on at the clinic in terms of the practitioners there. For instance, I have been trying to find out what experience and training these doctors have with stem cells.

Whoever heard of a medical clinic that won’t tell you who its doctors are?

Nervana Ad close up FDAAlso, I have other questions. Is their amniotic stem cell therapy based on living cells or some extract?

I’m guessing it is the latter, but the ads seem to imply the former. In either case, what is the source of this amniotic material?

Their most recent ad also claims that the FDA is OK with their treatments, but is that right? In part it would depend on that question as to whether they are using living cells, the source of the cells, the question of homologous use (e.g. are amniotic stem cells similar enough to joint tissue to be considered not a drug requiring preapproval from the FDA before use), and much more.

It seems like at this point we have tons of questions about this stem cell clinic in the Northern California area and our community, but few answers.

An important additional question at another level is whether the SacBee should even be running these ads given this context and so many unknowns about this business. I’m trying to ask our local paper about this, but so far haven’t gotten very far.