Stem cell companies and physicians market so-called “government-approved” treatments as miracle cures, with medical centers and pain clinics nationwide promoting them as advanced solutions for pain and chronic conditions.
But even with costly treatment plans, there is no guarantee that the therapy will work on an individual basis. They may even harm patients, as seen in several lawsuits filed due to stem cell treatment injuries.
Such unproven stem cell therapies fuel a $16 billion industry, where clinics target aging patients with aggressive marketing. These treatments often cost tens of thousands of dollars despite lacking support from clinical trials.
Joe Lyon is a consumer safety lawyer investigating stem cell fraud and deceptive medical advertising. Patients harmed by unproven treatments can contact The Lyon Firm at (513) 381-2333 or online for a free, confidential consultation about a potential stem cell lawsuit.
Stem Cell Fraud Continues Despite Federal Warnings
The Food and Drug Administration (FDA) took significant action in 2017 to shut down a regulatory loophole that allowed clinics to market unproven and potentially dangerous stem cell therapies. The agency declared these treatments illegal and began enforcing compliance with updated guidelines. However, change has been slow, and many unregulated stem cell clinics continue to operate outside federal oversight.
With an estimated 2,700 clinics across the country, the FDA faces an ongoing challenge in identifying which providers follow the law and which promote fraudulent stem cell therapy. Critics argue that these businesses often target vulnerable patients with misleading claims and urge stricter regulation.
To date, the FDA has issued more than 400 warning letters to stem cell marketers and healthcare professionals. In response, consumer protection attorneys have filed class action lawsuits against several clinics accused of deceptive practices and patient harm.
Despite the lack of scientific support, clinics continue to advertise stem cell treatments for a wide range of conditions, including chronic pain, orthopedic injuries, heart and lung disease, multiple sclerosis, Parkinson’s, Alzheimer’s, autism, diabetes, erectile dysfunction, and vision loss.
Providers often charge tens of thousands for these procedures, rarely secure insurance coverage, and frequently deliver no benefit. In many cases, patients suffer adverse effects due to improper administration or untested materials.
Consumer safety lawyers believe stem cell therapy fraud represents a growing threat to public health. Unlicensed and unethical providers will continue putting patients at risk if the FDA fails to act soon.
Does Stem Cell Treatment Work?
Because stem cell treatments are not required to undergo clinical trials for FDA approval, doctors have limited data or research to rely on. The effectiveness of these therapies remains highly questionable. One thing is certain: they are expensive, and patients often pay thousands of dollars out of pocket for a treatment that fails to deliver the results promised by providers.
Many providers administer stem cell procedures without any specialized training or education. Chiropractors, beauticians, and sports therapists can enter the market and sell treatments with little to no medical oversight. A typical session may last only ten minutes but cost upwards of ten thousand dollars. Will the treatment work? Yes. No. Maybe. It depends—often without scientific guidance or clinical support.
Manufacturers ship cryogenically preserved amniotic stem cells to clinics, where staff inject the product into patients. However, research suggests that many of the potentially beneficial cells do not survive the preservation and delivery process. Once injected, these non-viable cells offer no therapeutic benefit.
A recent investigation by ProPublica and The New Yorker revealed physicians working with stem cell clinics that market unapproved treatments for chronic pain, multiple sclerosis, and kidney disease. The report uncovered widespread deceptive marketing, inflated pricing, and a troubling disregard for patient health in the amniotic stem cell therapy industry.
Even respected scientists who have studied stem cell therapies for decades acknowledge there is little evidence to support claims that amniotic cell products help with most medical conditions.
Currently, the only FDA-approved stem cell therapy treats blood disorders such as leukemia. Still, stem cell clinics continue to promote treatments for a wide range of unrelated conditions, including pain relief, cosmetic procedures, arthritis, tendinitis, psoriasis, lupus, hair loss, scarring, erectile dysfunction, heart failure, COPD, asthma, emphysema, stroke, Alzheimer’s, multiple sclerosis, ALS, neuropathy, diabetes, dry eye syndrome, macular degeneration, and kidney failure.
These treatments remain experimental. Doctors have a professional duty to approach them as such and avoid misleading patients with claims of a “miracle cure.” When clinics exaggerate benefits or minimize risks, patients may become victims of stem cell therapy fraud.
The Lyon Firm is currently investigating cases involving deceptive medical advertising and stem cell scams. In these cases, patients paid high prices for unproven treatments that resulted in no improvement or worsened conditions. Many of these therapies were marketed to vulnerable individuals seeking relief from pain, inflammation, or degenerative diseases.
If you or a loved one received stem cell treatment and experienced little to no benefit—or suffered complications—legal action may be an option. Contact attorney Joe Lyon at (513) 381-2333 or online for a free consultation and a confidential review of your potential case.
ABOUT THE LYON FIRM
Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.
The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.
NO COST UNLESS WE WIN
The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.
Is Stem Cell Treatment Safe?
Stem cell therapy remains in the experimental stage, with most procedures still under clinical investigation. Yet clinics across the country continue to offer injections to the public, claiming they can repair or regenerate tissue—even without FDA approval or long-term safety data. While the idea is appealing, unproven stem cell treatments carry serious risks.
Some patients have suffered serious harm after receiving contaminated or improperly prepared stem cell products. Several individuals were hospitalized with severe infections, leading to new safety warnings from health officials. In multiple cases, tainted supplies caused swollen spinal discs, infected bones and joints, and abscesses. These outcomes highlight the dangers of stem cell therapy malpractice and the need for oversight.
Physicians and providers often downplay the risks when promoting these treatments, but they have a legal and ethical duty to inform patients of all potential outcomes. Some clinics administer stem cell injections without proper safeguards, such as screening for bacteria or maintaining sterile conditions.
The Centers for Disease Control and Prevention (CDC) has documented at least a dozen cases of adverse reactions linked to unregulated stem cell therapy. Patients developed serious complications shortly after injections, raising further concerns about the integrity of the supply chain and the competence of those administering the treatment.
The FDA has repeatedly warned the public and providers about severe side effects associated with stem cell products. Potential risks include poor injection site reactions, the unintended growth of tumors, failure of the cells to function as claimed, and exposure to contaminated materials. Injured patients increasingly report these complications after providers allegedly deceived them through stem cell scams or failed to secure informed consent.
Federal officials have emphasized their commitment to advancing regenerative medicine, but only through safe and scientifically valid pathways. The FDA has openly criticized companies that “skirt safety measures” and “put patients at risk,” reinforcing that the unregulated stem cell industry poses real and immediate health threats.
Patients considering treatment must weigh these risks carefully. Clinics offering unapproved or untested therapies may place profits above safety, leaving patients vulnerable to physical and financial harm. Stem cell fraud often begins with false promises—and ends in preventable injury.
Stem Cell Fraud Lawsuits
A Pennsylvania woman filed a stem cell lawsuit against a chiropractor and a product manufacturer, claiming they misled her into paying thousands of dollars for a treatment marketed as an arthritis solution. According to the complaint, the procedure failed to deliver results and was both ineffective and expensive.
Stem cell scam cases like hers are becoming more common as patients discover the gap between the promises made by stem cell clinics and the reality of the treatments provided.
Across the country, researchers, physicians, and for-profit companies have persuaded many consumers to believe that stem cell therapy can regenerate tissue, eliminate chronic pain, and even cure life-threatening diseases. While the science behind regenerative medicine holds promise, most of these claims lack the clinical evidence necessary to justify their widespread marketing.
Some companies describe their offerings as “miraculous” or say the products “stimulate regenerative healing,” even though such statements often cannot be substantiated. These bold marketing tactics have drawn the attention of consumer safety lawyers investigating stem cell fraud and seeking accountability for deceptive advertising and medical misconduct.
In theory, stem cell therapy offers the potential to repair, restore, replace, and regenerate damaged tissues and organs. In practice, however, many marketed treatments remain untested, unregulated, and potentially unsafe. Health officials warn that certain procedures may violate FDA rules prohibiting the use of unapproved drugs, especially when clinics fail to follow necessary safety protocols.
Patients who believe they were misled or harmed by these therapies may have legal grounds to pursue compensation. Attorneys filing stem cell therapy fraud claims aim to protect patient rights and raise awareness of unethical practices in a fast-growing, lightly regulated industry.
“Too often, patients are sold hope disguised as science. Every case we take is about uncovering the facts, holding bad actors accountable, and helping clients get the justice and support they deserve.”
Joe Lyon,
Founding Partner of the Lyon Firm
How to Spot Red Flags in Stem Cell Therapy
Patients considering stem cell treatments should stay alert to the warning signs of unethical practices or stem cell therapy malpractice. Because the industry is loosely regulated and widely marketed, identifying questionable providers can help avoid unnecessary harm and financial loss.
The following red flags may indicate a high risk of stem cell fraud or deceptive practices:
No Discussion of Risks
Legitimate medical providers explain all known risks and potential complications. Stem cell therapy is experimental and not without danger. Claims of “no risk” are misleading and irresponsible.
Testimonials Instead of Evidence
Clinics promoting success stories without referencing clinical trials or peer-reviewed research may conceal the lack of scientific support for their procedures. Personal anecdotes are not a substitute for evidence-based medicine.
Unclear or Missing Stem Cell Sourcing
Ethical providers clearly explain where they source stem cells, how they process them, and whether the products meet FDA standards. Refusing documentation or literature should be treated as a red flag.
One Treatment Claims to Fix Everything
No single type of stem cell can treat all diseases or injuries. Clinics that promote a “one cell cures all” message are engaging in false advertising and potentially committing stem cell therapy malpractice.
Hidden Costs or Pay-To-Participate Models
Treatments that are not FDA-approved are usually not covered by insurance. Providers must fully inform patients of all costs before obtaining consent. Pressure to pay upfront or participate in costly “trials” can signal fraud.
Lack of Proper Medical Credentials
Chiropractors, aestheticians, or fitness professionals sometimes perform these procedures without proper medical oversight. Patients have the right to verify the medical training of anyone offering stem cell therapy.
Patients exploring experimental treatments in a safe, regulated setting can search for verified clinical trials through the National Institutes of Health (NIH). The NIH provides a comprehensive list of approved stem cell therapy trials, helping consumers avoid deceptive marketing and unauthorized procedures.
Contact a Stem Cell Fraud Lawyer
Patients deserve transparency, safety, and honesty when exploring medical treatments. When clinics prioritize profit over care and treatments fail to deliver promised results, legal action may be the most effective way to hold providers accountable and protect future patients.
For over 21 years, The Lyon Firm has fought for individuals in complex medical and product liability cases, including those involving unproven or dangerous stem cell procedures.
Joe Lyon works closely with victims and their families to uncover the truth, pursue full compensation, and hold negligent providers accountable. His advocacy has resulted in life-changing settlements that support long-term care and help families recover after devastating losses.
If you or a loved one experienced injury, illness, or financial harm after receiving stem cell therapy, you may have a valid claim for stem cell therapy malpractice. Call The Lyon Firm at (513) 381-2333 or contact us online to schedule a free, confidential case review.
Consumer Rights & Justice
Understanding Stem Cell Fraud Lawsuits
Filing a Consumer Fraud lawsuit is a complex and serious legal course and can carry monetary sanctions if the proper legal process is not followed. The Lyon Firm is dedicated to assisting plaintiffs work toward a financial solution.
We work with law firms across the country to provide the most resources possible and to build your case into a valuable settlement. The current legal environment is favorable for consumers involved in data breach class actions, deceptive marketing lawsuits, TCPA telemarketing claims, financial negligence, and various fraud claims.
