FDA To Discuss Stem-Cell Regulation

FDA To Discuss Stem-Cell Regulation

The United States Food and Drug Administration (FDA) are holding two days of hearings next month to decide whether clinics offering stem-cell treatments should face stricter regulation.

Very few of these treatments have been approved by the FDA. However, due to a lack of regulation, clinics offering “stem-cell” treatments are spreading across the United States and leading stem-cell scientists are calling on the FDA to take action.

Stem-Cell Treatments

A recent study published in the journal Cell Stem Cell reported 570 clinics advertising stem-cell therapies directly to consumers. They claim to treat a wide variety of disorders, even though these treatments have not been properly tested and approved, and charge thousands of dollars.

The only stem-cell treatments that have been approved by the FDA use cells taken from bone marrow, and even those are under certain restrictions. The clinics in question say they don’t need FDA approval because they are not creating drugs. They are, in a sense, correct. A substance derived from a patient’s own cells isn’t considered a drug subject to approval by the FDA.

The Federal Trade Commission (FTC) has brought charges against clinics for deceptive advertising. But this is usually for advertising dietary supplements. They have not yet acted in force against the misleading advertising of stem-cell treatments.

Growing Trend in Australia

There is a similar trend on the rise in Australia. A new study ranked the country among the world’s highest concentration of stem-cell businesses advertising medical and cosmetic treatments online. Its author, Professor John Rasko of the University of Sydney, called on Australia’s medical regulator to stop these businesses from offering potentially ineffective and harmful treatments.

Many of the treatments being offered by clinics in Australia are still undergoing clinical trials in academic centres. This means the safety and efficacy of these treatments have still to be proven.

There has already been casualties as a result. In June, a New South Wales coroner found that a 75-year-old woman had died after undergoing experimental stem-cell treatment for her severe dementia. Sheila Drysdale had died as a direct result of blood loss suffered following a liposuction stem-cell procedure.

Latest Developments

These clinics are threatening to overshadow the excellent work being done by researchers and scientists around the world. RenovaCare, a New York-based biotech company, is working on a skin gun that sprays skin stem cells on a burn or chronic wound to promote rapid healing. Once these skin cells are applied, they say it takes only a few days for the treatment to be effective. The company recently a filed a 510(k) submission with the FDA, which is a notice of intent to market a device and often is the first step before clinical trials.

Another team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage. A month after their strokes, the mice that received the stem cells performed significantly better on tests of motor and sensory functions compared to mice that received neither.

Conclusion

One thing is clear - stem cells offer enormous potential. They could be used to cure diseases, mend tissue and even grow replacement organs. However, the market needs adequate regulation to protect the research being done and to safeguard the public from the unregulated, unsafe treatments being offered by these clinics.  

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