Proposed Stem Cell Class Action: “QC Kinetix Illegally Fails to Disclose Lack of FDA Approval of ‘Worthless’ Stem Cell, Regenerative Treatments in Florida”
A proposed class action alleges QC Kinetix and related defendants failed to disclose that certain regenerative pain treatments were not FDA-approved and used misleading financing offers to sell them.
Key findings
- A proposed class action says QC Kinetix clinics in Florida failed to give legally required notice that certain stem cell and related treatments were not approved by the FDA.
- The complaint ties those allegations to Florida’s new stem cell therapy law, SB 1768, which requires specific advertising and consent disclosures for these treatments
- The lawsuit also alleges misleading financing offers involving Med-Den Funding and seeks to represent Florida consumers who bought these services.
Florida’s new stem cell therapy law is central to a proposed class action against QC Kinetix and related defendants.
Quick intro to the laws
Not legal advice.
Orthopedic patients in the USA can get “stem cell therapy” within certain limitations. Platelet-rich plasma (PRP, which is not a cellular therapy but often thrown into the same bucket), bone marrow concentrate (BMAC), and sometimes adipose-derived therapy (MFAT) are mostly allowed, as long as they’re autologous (sourced from the patient), minimally manipulated (no culture expansion or other manipulation), and meet a few other conditions. These therapies are available at thousands of clinics around the country.
Wharton’s jelly and other umbilical-derived stem cell therapies are mostly federally illegal until the indication receives FDA approval, requiring full clinical trials. However, there have been a few shots across the bow of the FDA in recent years. Utah, Nevada, Texas, and most recently, Florida have all either deployed or introduced bills to allow umbilical-derived stem cell therapies, subject to certain limitations.
Florida’s bill, SB 1768, was passed in the summer of 2025 and allows these unapproved, birth-tissue-derived therapies, but it comes with strict advertising, third-party analysis, and informed consent requirements, including informing patients that these therapies are not FDA-approved.
Who is QC Kinetix?
QC Kinetix (QCK) is a Charlotte-based regenerative medicine franchise founded in 2017. The company markets non-surgical biologic treatments for joint pain, musculoskeletal injuries, and chronic conditions. In 2023, the company reported $100.5 million in systemwide sales, according to this press release.
From what I gather, QCK mostly deals with PRP/BMAC and has several locations across the country.
What’s interesting is that it appears the new Florida bill is being used against them and their use of PRP/BMAC treatments.
The class action
The case, filed as Estrada et al. v. QC Franchise Group LLC et al., names QC Franchise Group LLC, Med-Den Funding, LLC, and Regencare 1142, LLC, doing business as QC Kinetix Doral. According to the complaint, the defendants marketed regenerative pain procedures to consumers in Florida without properly disclosing that the treatments were experimental and not approved by the FDA.
The complaint also mentions that the omission was not accidental, and QCK used a broader sales strategy aimed at quickly moving patients into consultations, financing, and treatment purchases. It alleges that prospective patients were drawn in with promises of “miracle” pain relief and financing offers such as “0% interest” or monthly payments “as low as $100 per month,” only to later receive loans with higher interest rates and added fees through Med-Den Funding.
According to the lawsuit, these services were promoted as alternatives to surgery for chronic pain, particularly to older and medically vulnerable patients. The filing also references prior FTC scrutiny of stem cell marketing, including allegations in Federal Trade Commission v. Peyroux, to argue that claims comparing these treatments to surgery or positioning them as highly effective have already drawn regulatory attention.
The class action seeks to represent Florida consumers who purchased these services from QCK, and as with any new complaint, the allegations have not been proven in court.
I say this almost every day; this is the most interesting and juicy industry I’ve ever covered. Stay tuned.
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