Stem Cell Institute of America Changes Its Tune?

I’ve written several times about Stem Cell Institute of America (SCIA), a chiropractic group that uses mostly mid-level, non-physician providers to perform amniotic and cord blood dead stem cell procedures. In spite of their marketing, behind the scenes, they claim to be nothing more than a marketing group and not a true medical network. A colleague went to their recent seminar and wrote me about what they said. The good news is, they seem to now have changed their tune and are “talking the talk”, now can they “walk the walk”?

An Expose on SCIA

After we discovered that amniotic and cord tissue products currently on the market have no stem cells, I was floored to see a group of chiropractic clinics aggressively marketing these products as “stem cell therapy.” I first blogged on this chiropractic stem cell group a few years back and here’s a video expose based on what they have said and marketed under a number of company names:

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Brent Detelich Steps Down

The chiropractor running this group had been convicted of health care fraud 10 years earlier in an unrelated matter and after the above video aired, we were told by the company that he stepped down as president. Would the company change its ways? Would they change the deceptive bait and switch marketing tactics used by their member clients?

A Colleague Who Attended their Recent Conference

I recently received an email from a medical colleague who decided to attend the SCIA conference. Here’s his take on what they said on stage:

• If you are going to say “stem cells”, the only product that meets the FDA criteria is bone marrow. “If your marketing or ads say stem cells you better be using bone marrow”.
• Of the doctors online in the webinar portion of their presentation (I assume that they could poll easily), 51% said they use amniotic and 30% umbilical. That means that 81% are still using these tissues.
• They said umbilical cord blood does not pass muster for homologous use.
• They cautioned their members not to treat various diseases outside orthopedics or from performing IV “stem cell” therapy.
• They want their clients to get more training.
• They want their members to follow their patients for 12 months and track outcomes.

All of this sounds like it was written by me or plucked from one of my lectures on the wild west of stem cells.

Talking the Talk vs. Walking the Walk

So on the positive side, SCIA appears to be “talking the talk”, meaning they are saying all the right things, at least at their annual conference. However, even as I write this blog, their website still says that they’re using an amniotic product, which it also describes as a cellular therapy. Hence, the mothership has yet to correct the messaging.

The big issue is whether they can actually force the chiropractors advertising under their banner to comply with the law and avoid the bait and switch marketing schemes. That may be easier said than done. Why?

We know in writing that SCIA sees itself as a “consultant,” meaning that while the average consumer would believe SCIA to be a provider network with rules, it’s actually a marketing facade for the practices who are the customers of the consultant. As a result, SCIA takes no responsibility for the treatments provided at the offices that advertise under its banner. Let me explain.

As an example, if you claim to be a licensed physician with board certification in cardiology and Cigna and/or United Healthcare finds out that this isn’t true, they reserve the right to drop you from their provider panel. Or if your license becomes restricted because of a medical board sanction, you may also be exited from the network. Hence, the public knows that there are standards when they see an “in-network”. physician.

How will SCIA enforce the things that it claims are standards when it considers itself merely a consultant? A consultant can recommend anything it wants and the client is free to do what he or she wants. So let’s explore how SCIA could clean up the ethical mess it’s created.

Cleaning Up the Mess

The Name

In its various incarnations, SCIA consistently uses the term “stem cell” in its name and throughout its widespread marketing efforts. Having checked in on several of these chiropractic offices, most use amniotic or cord tissue which is regulated to be non-viable (Dead) and of course has no live and functional stem cells. Also, realize that the FDA is a claims made regulatory system. Meaning that simply claiming you’re using stem cells from a third party source would require that the product be FDA approved with years of clinical trials for each indication, which these tissue products don’t have. This still holds true even if the product you’re using has no live stem cells.

In other words, the FDA’s regulations make clear that if an allogeneic product (like amniotic membrane or cord blood) is claimed to rely on the metabolic activity of living cells for its primary function, then it cannot be used on human patients without express permission from the FDA. None of these products have that type of FDA approval.

Despite these issues, SCIA’s data collected at its conference from the online crowd shows that more than 80% of their client practices use these tissues and describe it as “stem cell therapy”. We also know from the conference that by the group’s admission these are not “stem cell” therapies, thus calling into serious question why it would continue to refer to itself as a “stem cell” – focused organization.

The Advertising

We have several SCIA client clinics near us and all use the term “stem cell” in the marketing and none, in fact, as detailed above, are injecting live and viable stem cells. Now we also have confirmed that the “consultant” has deemed this sort of advertising as not compliant. Will they change?

Umbilical Cord Blood

The consultant says that umbilical cord blood can’t be legally used to treat orthopedic conditions. Why? First, FDA regulations require that these regulated tissues be used in a patient in the same way the body uses them. The only safe approved use of cord blood is pediatric cancer. And again, if an allogeneic product like cord blood is dependent upon the metabolic activity of living cells for its primary function, it cannot be used on human patients without express permission from the FDA. However, SCIA has numerous client clinics that use it to treat knees, shoulders, hips, etc., so if SCIA is serious about FDA compliance, all of its clinics would have to abandon this practice.

IV Therapy

Most package inserts I have seen that come with amniotic and cord blood products state that they are not for intravenous use. Why? At the end of the day, while an IV is a simple thing to do in a clinic, it’s a very risky route of therapy for any investigational substance. For example, you can’t control where the injection is going and thus if it will have an impact on many body systems. While amniotic tissue has been used in surgery and cord blood has been used for pediatric cancers, there is no safety data for IV use.

Training

Almost all SCIA client clinics that I have seen use mid-level providers (nurse practitioners and physician’s assistants) instead of highly trained physician specialists. Why? This is the best way to minimize cost to the clinic and maximize profit. If SCIA wants to change to using bone marrow (which they seem to be hinting at), as I have previously written, a bone marrow aspirate is generally considered beyond the scope of practice for a mid-level provider. While this type of procedure may be performed by a mid-level in an oncology practice in a hospital setting with physician specialist supervision, we’re talking about a chiro office here. Hence, if SCIA is going to fix its training problem it needs to hire many physician specialists and get rid of the mid-levels. Will this happen?

Tracking Outcomes

We have collected more registry data on orthopedic stem cell treatment outcomes than any other group on earth. In fact, there is no close second. SCIA says it wants its clients to begin tracking outcomes. This is easier said than done.

We have spent millions of dollars over 13 years collecting data. It’s a very big job that requires not only specialized software and real people who bother patients to get the needed information, it also requires a tremendous commitment of each office, whose staff needs to make sure they submit all of the data on each patient. Can SCIA require its consulting clients to collect data? For example, if a Regenexx network provider clinic refuses to collect data then it can be removed from the network. How will SCIA deal with clinics who don’t want to make this commitment?

The upshot? Will SCIA clean up its act? Can it? Will it begin exiting client clinics that don’t follow the rules or will it focus on maximizing profit as a consultant? Will it “walk the walk” or just “talk the talk”?

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile