QC Kinetix is a relatively new regenerative clinic brand in the U.S. selling unproven cell therapies.
I see several specific red flags including a class action lawsuit.
They report having 150+ locations, making it potentially the largest chain of unproven clinics in the U.S. Collectively, these clinics could be seeing tens of thousands of customers. Its size and the nature of its offerings raise concerns for me about both health risks and economic impacts.
Let’s take a close look.
What is QC Kinetix? | QC vs. other clinic chains | FDA compliant? | Class action suit | Overall QC Kinetix review | References
Quick QC Kinetix review. As a stem cell researcher, I do not believe there is good evidence to support this brand’s claims. I see several red flags including the apparent lack of published clinical research and a patient class action suit. Many of their clinics may not have full-time physicians on staff, which is another concern. I do not recommend these clinics to readers of The Niche.
What is QC Kinetix and who are its leaders?
QC Kinetix sells a variety of unproven regenerative offerings. It seems to be owned by QC Franchise Group. The individual QC Kinetix clinics function as franchises.
According to the firm, Tyler Vail, a physician assistant, co-founded QC Kinetix along with entrepreneur Justin Crowell, and Dr. Richard Schaffer.
Right off the bat, one red flag here for me is a lack of published regenerative medicine research experience by the leaders. For instance, I don’t see that the long-term QC leadership has published papers on regenerative medicine. PubMed searches found nothing relevant.
There also seem to be no active clinical trials on Clinicaltrials.gov, although I did find one withdrawn QC Kinetix study on PRP. There is a note there saying “The study format without a crossover option for study participants enrolled in the control arm wasn’t attractive to patients and we were unable to enroll any patients since enrollment began earlier this year, so the study will be withdrawn.”
QC Kinetix clinics vs. other stem cell clinic chains
How does QC compare to the other three big regenerative clinic chains?
For a long time the largest networks of American stem cell clinics were Cell Surgical Network, R3 Stem Cell, and Regenexx. QC Kinetix really took off relatively more recently. It’s possible they have more locations than any other regenerative clinic group in the U.S. now.
QC appears to sell PRP and some kind of stem cells. Part of the ambiguity here is that, at least for me, it was difficult to find out on the QC websites what they are actually selling now in the way of biologics.
In searching through a dozen of their clinic location websites, it’s also often hard to tell who the providers are. Many clinics list no specific providers on their websites. A few list MDs while some other QC clinic websites list only non-physician providers. This lack of clarity and the apparent running of some clinics without physicians there full-time are concerning to me.
How closely are QC’s physicians monitoring the PAs, nurse practitioners, or nurses doing procedures? Note that PAs and others at that level can be part of legitimate clinical trials and administer cells to participants. However, this is typically done as part of a large team with extensive expertise and supervision by experienced researchers and physicians.
It seems that some QC locations are owned by nurses or possibly non-physicians as well. See the marketing video below. As a side note, this video is by a local TV station, which is part of a larger trend of such stations cashing in on doing promotional segments for unproven regenerative and stem cell clinics all across the U.S.
FDA compliant?
As I said, QC’s websites are somewhat vague about the biologics that they sell.
For that reason, it’s difficult to determine if they are likely to be FDA-compliant or not. I called one of their clinics to try to find out more. The representative said they use PRP and stem cells. However, she wasn’t able to tell me what kind of cells. To get that info she said I’d have to come in for a consultation.
If QC Kinetics clinics in general are now just selling PRP for orthopedic conditions, that kind of application is generally viewed as FDA compliant. Using unmodified bone marrow products for orthopedic conditions is also generally seen as compliant.
In contrast, use of adipose cells, perinatal products, and exosomes, which are drugs, requires working with the FDA in advance. A few years back Chris Centeno mentioned use of such products by QC in a post on his Regenexx blog. I don’t see clear indications that such materials are being used now, but it’s hard to tell for sure.
In general, for use of adipose cells, perinatal products, and exosomes, one has to go through multiple steps like getting an IND even to do clinical trials. This is not just a technicality. It’s an important process to give the best odds of safety and efficacy. Even so, hundreds of American stem cell clinics market these products in a non-compliant way with no FDA involvement.
I wasn’t able to find any indication that QC has an IND or BLA from the FDA, although such matters are sometimes confidential. At this point, I see no evidence of any FDA actions taken on the firm.
Class action suit against QC Kinetix owner QC Franchise Group
There is, however, a class-action lawsuit against QC Kinetix. The suit has many concerning allegations.
The key assertion is the following: “An Indiana consumer alleges in a class action that she was physically and financially injured by expensive medical treatments misleadingly advertised by QC Kinetix.” Further:
“The 28-page case claims QC Kinetix, which is operated by defendant QC Franchise Group, has run afoul of state law by failing to adequately disclose to consumers that the non-surgical alternative pain treatments it offers involve the use of drugs that have not been approved by the Food & Drug Administration (FDA). In further violation of state law, QC Kinetix has accepted loan payments for treatment that were made pursuant to financing contracts that lacked a required notice about loan cancellations and refunds, the filing contends…
The case goes on to explain that after receiving two of the five scheduled treatments, the plaintiff saw “no benefits” and developed shoulder pain “so severe” it kept her up at night and forced her to start wearing an arm sling.”
There are several comments on the Class Action lawsuit article that are notable.
Overall QC Kinetix review
Overall, my review of QC Kinetix is that it sells unproven biologics that are likely to have risks and I’m skeptical about the potential for lasting benefits. In addition, it’s unclear whether they have sufficient physicians to supervise the procedures being done at all those franchise clinics.
The patient class action suit raises more concerns and unanswered questions.
The firm is also not BBB accredited. The BBB overview of the QC Kinetix is quite negative with many comments from upset customers.
References
- Patients should talk to their physicians about healthcare decisions including on regenerative therapies.
- Chris Centeno has covered this clinic chain in some depth over the past few years on his Regenexx blog.
having read the complaint I find it interesting that the entire question of whether or not this treatment itself was fraudulent, is nowhere to be found. Nor do i see a direct claim of practicing medicine without a license. The entire case is based on the lack of notification to the patients that this was not an FDA approved treatment; and the fact that the finance agreement lacked a disclosure explaining that the borrowers, the patients, could get their money back. As a legal matter it is a more elegant approach, and doesn’t require the expert witnesses that a typical malpractice suit, for instance, would require. So quicker, cleaner and cheaper to bring; and win. The only way this might veer into the regenerative medicine arena is if part of the defense is “it is not a drug”. The allegation that it lacks the disclosure “it is not an approved drug” relies on that. My guess is the defendants will stay away from that one as there is ample evidence of the FDA’s ability to regulate this type of material. In the end, I suspect defendants will settle with the “class” in Indiana and simply change their paperwork to make the two missing disclosures and continue this unabated. High pressure sales campaigns work against vulnerable patients regardless of what’s in the “small print”.
@Richard, Thanks for your insights. A settlement does seem likely in this case.
More generally, one of the challenges for the handful of big US clinic chains is that they have potentially thousands of patients/customers spread over dozens of states. That makes things potentially very complicated.
On a different case, any thoughts on the 9th Circuit win for the FDA? Could the full court agree to look at the case or are they more likely to let the 3-judge panel’s decision stand?