Unregulated Stem Cell Therapy Brings More Harm Than Help

Stem Cell Therapy

Unregulated Stem Cell Therapy Brings More Harm Than Help

In September 2019, the U.S. Food and Drug Administration (FDA) issued a warning to consumers: “Watch out for unapproved stem cell therapies!” The warning comes from the agency in response to the mounting concern of patients seeking cures and pain remedies who are vulnerable to stem cell treatments that are illegal and potentially harmful.

Stem cell therapy has gained a reputation for serving as a miracle treatment for repairing diseased tissue, purportedly healing ailments from arthritis to cancer. However, there is a great deal of information that has yet to be learned about stem cells and much of the claims remain unproven.

The FDA has only approved a few stem cell therapies, yet over the past few years, they have witnessed clinics across the country promising miracle results for chronic pain, Alzheimer’s, and cancer; touting these cures as FDA approved.

The FDA wants consumers to be aware that dishonest and unscrupulous stem cell clinics are preying on the vulnerabilities of patients desperate for a cure. Many of these treatments, which are often very expensive, have not been proven effective by medical evidence and are not approved by the agency. The Food and Drug Administration is responsible for protecting the public health and their warnings should not be taken lightly.

“This is yet another example of how people in desperate search of a medical cure fall prey to those who only care about money, that value profits over patient safety. We must be careful not to be taken in by these profiteers. And, when they harm people, we must be thankful that our Constitution guarantees each of us the right to hold wrongdoers accountable for the harm they cause,” advised medical malpractice attorney Sean Domnick, a Shareholder at Rafferty Domnick Cunningham & Yaffa.

Before any patient considers stem cell therapy, they should first ask their health care provider to confirm it is agency approved and request an FDA-issued Investigational New Drug Application number, even if the stem cells are your own. You can also visit this FDA website to see a list of FDA approved stem cell products.

What are Stem Cells?

According to the Mayo Clinic, “Stem cells are the body’s raw materials — cells from which all other cells with specialized functions are generated. Under the right conditions in the body or a laboratory, stem cells divide to form more cells called daughter cells.” Used in therapies such as injections, stem cells have the potential to provide replacement cells for any part of the body — blood, brain, bones, or organs.

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What are the Dangers of Unregulated Stem Cell Injections?

In 2018, a Centers for Disease Control and Prevention (CDC) report documented bloodstream infections in several patients who had received stem cell injections that were not approved by the FDA. Infection types included bloodstream, joint, and epidural abscesses caused by e-coli. In the most disturbing cases, patients suffered blindness, intense stabbing pain, lengthy hospitalizations, and even death after receiving a stem cell injection.

While the future of stem cell therapies is promising, leading researchers believe there is still much that needs to be understood in order to safely administer stem cell therapy. In the interim, patients do not have to allow predatory clinics and doctors to place profits over patient safety by luring them in with false hope. A patient who has suffered the dangers of unregulated stem cell injections could contact a medical malpractice attorney for help. Call today.

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NOTABLE RESULTS

Selected medical malpractice and broader catastrophic injury results reported by RDCY:

$31,000,000 catastrophic injury result · $2,500,000 medical malpractice settlement

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RDCY’s notable-cases page lists a $31,000,000 catastrophic injury result in Fort Lauderdale. This is a broader firm result; the source does not identify it as a settlement or verdict or specify the type of accident. Read the published result.

RDCY’s January 25, 2023 announcement identifies a $2,500,000 medical malpractice settlement among Nicole Kruegel’s recent resolutions. It does not identify the medical error or case location. Read the published result.

Prior results do not guarantee a similar outcome. Each case is different and must be evaluated on its own facts.

WHAT OUR CLIENTS SAY

General feedback about working with Rafferty Domnick Cunningham & Yaffa, excerpted from five-star Google reviews with written comments. Reviews reflect individual experiences.

“Every step of the way, Greg kept us informed and answered all of our questions.”

— JAE1430

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“She was always professional while at the same time being empathetic to my situation.”

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Professional Recognition

Selected credentials, honors and professional service of RDCY attorneys:

  • Sean Domnick — Board Certified in Civil Trial Law by The Florida Bar; also certified in Civil Trial Law by the National Board of Trial Advocacy. Source
  • Sean Domnick — Best Lawyers “Lawyer of the Year” for Medical Malpractice Law – Plaintiffs, West Palm Beach, 2024. Source
  • Nicole Kruegel — Best Lawyers: Ones to Watch, Medical Malpractice Law – Plaintiffs, 2024–2027. Source
  • Nicole Kruegel — Lawdragon X – Next Generation, Plaintiff Medical Malpractice and Birth Injury, 2026. Source
  • Nicole Kruegel — selected to Florida Super Lawyers, 2025–2026. Source
  • Sean Domnick, Nicole Kruegel, Fred Cunningham, Troy Rafferty and Gregory Yaffa — selected to the 2025 Lawdragon 500 Leading Plaintiff Consumer Lawyers. Source
  • Sean Domnick — President of the American Association for Justice, 2023–2024. Source
  • Sean Domnick — Florida Justice Association Al J. Cone Lifetime Achievement award, 2026. Source

Recognition applies to the named attorney and the stated year or period.

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