√ Customers Rate Nervana Stem Cell Clinic Harshly On Yelp

Sacramento’s Nervana stem cell clinic has been selling non-FDA approved stem cell therapies to patients for a variety of conditions including arthritis, pain, and neuropathy for a while now since last year, but in my opinion there isn’t good evidence to back up using amniotic or fat stem cells for such conditions. Further, my understanding is that if living amniotic stem cells are being used in this way, they would constitute a biological drug requiring FDA pre-approval. Nervana’s advertising is part of a larger trend of stem cell clinics paying for mainstream media ads to broaden their customer base.

Still, for a while there we in this community saw many ads for Nervana in our local paper the Sac Bee and some patients told me they had gone to the clinic. Others were interested in learning more. Overall, I view the kind of stem cell offering being sold at such clinics as at best a risky experiment. So how have patients who paid $5,000 to Nervana felt their ‘treatments’ turned out? It’s hard to be sure, but one place that we are increasingly seeing such isu on clinics pop up is on Yelp and other on-line review sites.

For Nervana, the Yelp reviews so far may be giving some indigestion. While there are only 4 reviews so far and that’s a very limited sample, the average rating is 2 out of 5 stars and it would be an average of 1 star, but for the single 5-star review.

The 3 out of 4 Nervana Stem Cell customers who gave it one star are specific about their reasons why. One reviewer Barbara says, “the treatment was a failure”, she never saw the doctor there, and she indicates that she believes further testing would have shown that she wasn’t a good candidate for the stem cell therapy to begin with. She mentions she wouldn’t mind a refund.

Another reviewer SR also has some negative words for Nervana Stem Cell and pointed out as well that he wasn’t seen by a physician. Finally, reviewer Liz, who weighed in first, is “very suspicious” and self-reports that her husband was a customer at the clinic.

These kinds of reviews may reflect a growing ekspresi dominan where when considering a stem cell treatment or after one is received, the public view themselves as consumers and if they aren’t happy they will say so. In the past, I’ve suggested to people to at a minimum do your due diligence in advance about a possible stem cell therapy that you would do in buying a car. Ask a lot of questions, be skeptical, get other opinions, and more. See my patient guide to stem cell treatments and talk to your primary care doctor. When in doubt, don’t do it.

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√ Groundbreaking New California Stem Cell Law Gives Consumer Protections On Clinics

California now has a first-of-its-kind stem cell law that requires clinics pitching non-FDA approved stem cell offerings to be upfront with patients. It’s a bill that will help to protect patients. How?

With Jerry Brown’s signature yesterday, the new California law mandates that stem cell clinics in our state take some steps to inform patients of various facts regarding what the clinics are marketing.

The bill, SB 512, was sponsored by Senator Dr. Ed Hernandez and now as a law adds Section 684 to the Business and Professions Code, relating to healing arts.

In the press release, Hernandez described the new law:

“I authored SB 512 to establish protections for consumers seeking early-stage, unproven experimental therapies,” said Senator Hernandez. “There are currently over 100 medical offices in California providing non-FDA approved stem cell treatments. Patients spend thousands of dollars on these treatments, but are totally unaware of potential risks and dangerous side effects. Thank you to Governor Brown for understanding the need for this law.”

The digest of the bill (now law) begins this way:

“This bill would require a licensed health care practitioner who performs a stem cell therapy that is not approved by the United States Food and Drug Administration (FDA) to communicate to his or her patient seeking stem cell therapy specified information regarding the provision of stem cell therapies on a specified notice in a prominent display in an area visible to patients in his or her office, posted conspicuously in the entrance of his or her office, and provided in writing to the patient prior to providing the initial stem cell therapy.”

The law requires this specific notification by the clinics:

“THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a stem cell therapy.”

This notice must be posted in the clinic and given in writing to the patients. The law also has some teeth to promote compliance. After the first violation, each subsequent violation results in a $1,000 fine.

Big kudos to Senator Hernandez and CCST Senate Fellow, Bao-Ngoc Nguyen, who made this possible through a lot of hard work. I was happy to have some tiny role in helping, including testifying at the Capitol here in Sacramento in support.

One of the most important sections gets the California State Medical Board involved:

“(e) The Medical Board of California shall indicate in its annual report, commencing with the 2018–19 annual report, all of the following with regard to licensees who provide stem cell therapies:

(1) The number of complaints received.

(2) Any disciplinary actions taken.

(3) Any administrative actions taken.”

Taken together, the provisions of this law will help consumers learn more about the stem cell clinic industry, make better decisions about their health and that of their loved ones, and delineate the difference between stem cell clinics versus compliant researchers conducting stem cell clinical trials with FDA approval.

In the big picture, this new California law plus a more active FDA on the stem cell front together give me more hope that the wild west of stem cell clinics can be reined in sooner rather than later! Perhaps other states will follow suit with new laws and state medical boards will get more involved in overseeing stem cell therapies. With more 570 stem cell clinics in the US and more than 100 here in California alone, more efforts like these are needed on the consumer protection and educational outreach front.

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√ Stem Cell Treatment Cost: You Often Don’T Get What You Pay For

How much does a stem cell treatment cost?

$5,000 is a nice round number that is probably close to the mark on average, but the price varies a great deal and depends on many factors.

Factors that influence perceived average price include what one actually sees as being under that umbrella term “stem cell treatment.” Does the transplant from a stem cell clinical trial count as a “treatment”? I’m not sure it should, but many view it as qualifying for that definition. By and large, you shouldn’t have to pay for the investigational offering itself in such a trial.

There may be other costs though such as hotel, food, travel, and certain expenses that neither the trial itself nor insurance will cover.

Once stem cell treatments are fully proven to be safe and effective as well as finally FDA approved, the costs are going to be high in many cases, but perhaps low cumulatively relative to standard medical care especially for chronic or severe conditions.  I’ve posted in the past about what FDA-approved stem cell therapies may cost in the future including here.

Within the for-profit stem cell clinic sphere, some of which characterize themselves as offering “clinical trials” and/or are listed in Clinicaltrials.gov, the costs you pay as a patient depend on certain factors including what profit margins the clinics are aiming for when they recruit you as a customer. I’ve posted before on for-profit stem cell clinic treatment cost as well here.

Notably, in the past few years probably due to competition from the hundreds of businesses out there, stem cell clinic charges to patients have dropped somewhat. A few stem cell clinics that mention price online seemed to hover around $4,500 for the first treatment and less for additional injections. A recent ad for a stem cell clinic recruiter suggested cost per treatment for patients was around $8,500.

I also did an internet poll last month (September 2017) asking readers of this blog who have had a stem cell treatment to indicate the range of the price that they paid. Overall, from what I understand from talking to patients, from the poll, and from talking to clinics over the years, at present most stem cell clinic-based offerings cost from $2,500-$7,500 per transplant. In the poll about 1/6 patients paid more, anywhere from $10,000 to above $100,000. Of course, such polling is not rigorous, but there isn’t much warta out there. Some patients are encouraged to get more than one treatment from a business so that’s another factor that can multiple total cost.

Another question is, “was the treatment worth the cost?”

Overall, I’d say that at clinics as a consumer you probably most often aren’t getting what you paid for, if one maintains high medical standards. Maybe almost never.

Why?

Many reasons come to mind.

Maybe the provider isn’t a specialist in the area of your condition (e.g. dermatologist treating your brain).

Often the therapy you purchased may have no living cells or have no actual stem cells in it (even as it is marketed as a “stem cell” therapy, suggesting to customers they are getting living stem cells.)

There usually will be no good, properly controlled data to back up safety and efficacy.

Follow-up to the infusion can be minimal.

The list goes on. A big overall factor here is that you are paying to be experimented upon, which in my view isn’t fair.

Another interesting question comes to mind: how much does it cost the clinics per “treatment” for stem cell offerings? And then, we can ask, how much profit do they make per treatment?

Clinics don’t open up about this stuff so it is left to some educated guesses and speculation. Apparently amniotic “stem cell” therapies often aren’t even real cell therapies and sometimes are just reconstituted protein extracts from amniotic membranes so cost there can be <$1,000 to the clinic.

Things like PRP, which are often mistakenly called “stem cell therapies”, can be cheap to make in the only hundreds of dollars a dose range. Adipose stem cell therapies involve multiple steps that can boost costs including liposuction and most often involve cellular processing into what is probably usually going to be a drug product. Bone marrow isolation isn’t trivial.

Other stem cell clinic offerings may cost the clinics anywhere from $1K-$2K, perhaps sometimes higher. The cost to the clinics more broadly will often depend on how careful they are with their QC and methods. The fact that so many clinics are not getting FDA approval surely reduces their costs, but at what cost to patients in terms of risks?

The economics of stem cells is an area more deserving of attention and it would benefit from hard data.

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√ Poll: How Many Stem Cell Treatments Have You Had?

The cost of stem cell treatments is a big deal for many reasons including the burden it puts on patients, who often then turn to friends, family and even the Internet to try to obtain the money needed to pay the for-profit clinic.

A reasonable question to ask is how the cost of a stem cell treatment compares to the costs of more standard of care options. Most often clinic stem cell offerings are more expensive, but not always. However, “value” is another consideration directly related to whether the clinic offerings are actually effective or not.

I recently did a poll on stem cell treatment cost that you can see here, which was very interesting. I’ve pasted an image of the results at right updated as of today. I haven’t crunched the numbers, but it looks like the average cost is around $7,500.

Many patients get more than 1 stem cell treatment and some get many on a regular basis over years, which of course impacts total cost. My impression is that the repeated injections are more common at adipose and amniotic clinics versus bone marrow ones, but no data on that.

Getting back to my earlier look at cost, I didn’t factor in multiple treatments into that poll, which would have ramped up total cost. Instead that poll more reflects price per treatment.

I have a new poll today with the question, “how many stem cell treatments you’ve gotten?” If you’ve had at least one stem cell treatment, please participate in the poll below. Thanks.

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√ Vampire Facial Update: Kardashian Has Regrets, Others Maybe Infections

What the devil is a vampire facial?

I first heard about the vampire facial, sometimes also called a “vampire facelift” when professional celebrity Kim Kardashian reportedly got one.

I weighed in on that five years ago here. There was some question in how this procedure was portrayed as to whether it involved stem cells, which seems unlikely at this point.

Kim apparently did this to try to keep a young look, but I figured it had to be risky. Now since her marriage known as Kardashian West, she reportedly has regrets about getting a vampire facial.

According to Allure,

“A few years ago, I heard about a ‘vampire facial,’ and I was so intrigued,” Kardashian West wrote. Right before she signed up to try the treatment, she found out she was pregnant, which meant that she couldn’t use the a numbing cream or painkiller before the treatment as doctors typically recommend, she says. That made for a super uncomfortable experience. “It was really rough and painful for me. It was honestly the most painful thing ever! It’s the one treatment that I’ll never do again.”

The procedure is risky too, which is not surprising if the devices are used with many clients and potentially not cleaned and disinfected properly. Microneedling devices used for these facials look like torture devices to me (see below).

CNN reported just a few days ago that a New Mexico firm called VIP Spa that sold vampire facials may have exposed clients to infectious agents including potential HIV and other viruses through questionable practices:

“Now the department (of health) is urging clients to visit the state’s Midtown Public Health Office this week for HIV, hepatitis B and hepatitis C lab testing and counseling.”

Some clinics and docs offering vampire facials also sell other iffy things like unproven stem cell offerings too, which could pose risks of infections and other negative outcomes.

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