Last week, two new papers came out echoing each other about the dangers of bogus “therapies” being offered by predatory stem cell clinics and the risks they pose to patients.

Unapproved Interventions

The first was from the Pew Charitable Trusts

The Pew report is titled “Unapproved Stem Cell Interventions Highlight Need for Greater FDA Enforcement,” with the subtitle “Unproven regenerative medical products have led to infections, disabilities, and deaths.” These titles convey the main message: the need for stronger FDA enforcement and the real harm these products cause.

Two days later, as if responding to that call, the Food and Drug Administration (FDA) released its own paper titled “Important Patient and Consumer Information About Regenerative Medicine Therapies.” Like the Pew report, the FDA paper highlights the dangers of unproven and unapproved therapies. It says the agency has received reports of blindness, tumor formation, infections, and other serious harms caused by these products.

FDA’s list

The FDA lists diseases and conditions that predatory clinics claim to cure without evidence that their products are safe or effective. It states that regenerative medicine therapies have not been approved for treating:

• Arthritis, osteoarthritis, rheumatism, hip pain, knee pain, or shoulder pain.
• Blindness or vision loss, autism, chronic pain, or fatigue.
• Neurological conditions such as Alzheimer’s or Parkinson’s.
• Heart disease, lung disease, or stroke.

The FDA says it has warned clinics offering these therapies to stop or face legal action. It also warns consumers: if you are being charged for these products outside a clinical trial, you are likely being deceived and offered an illegal product.

The agency advises consumers to contact the FDA at ocod@fda.hhs.gov if they are offered one of these treatments, which often cost thousands or even tens of thousands of dollars.

The Pew report shows how dangerous these treatments can be. It analyzed health records and found more than 360 reported cases of serious side effects from unproven and unapproved stem cell procedures between 2004 and September 2020.

Those side effects include 20 deaths and serious, sometimes lifelong disabilities such as:

• Partial or complete blindness (9).
• Paraplegia (1).
• Pulmonary embolism (6).
• Heart attack (5).
• Tumors, lesions, or other growths (16).
• Organ damage or failure, including several fatal cases.

More than 100 affected patients required hospitalization.

Most common unproven procedures

The most common procedure these patients received involved injecting stem cells taken from their own bodies. These might include injections into the eye, spine, hip, shoulder, or knee. Donor stem cell injections were the second most common procedure.

The Pew report cites a California stem cell company that sold products made without proper safety measures. This included failing to screen for diseases such as HIV and hepatitis B and C. These products caused serious bacterial infections that hospitalized at least 13 people in Texas, Arizona, Kansas, and Florida.

Despite these shocking statistics, the report says the true harm from these clinics is likely much higher. Clinics rarely report adverse events, and many patients do not report them unless the effects require medical care.

The Pew report concludes that the FDA needs more resources to act and shut them down when needed. It also calls on the agency to encourage doctors and patients to report unexpected side effects. The report states that gathering real‑world evidence of harm will help the FDA limit this unregulated market. In turn, it will help support a safe, trustworthy regenerative medicine field.

We fully support both reports and will continue working with the FDA and others to oppose these predatory clinics. Read more here about our efforts to stop these clinics, and find information here to help you decide whether a stem cell clinical trial is legitimate.