FDA Warns Consumers About Stem Cell-Based Treatments - Page

  • Posted on: May 9 2016
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Stem cell-based treatments have been a leading trend in the aesthetic industry for the last decade, but they may soon be a thing of the past. Just about ten years ago the very first claims were made about stem cell-based treatments, indicating that these “master cells” would lead to younger, healthier skin and erase the signs of aging.

What are Stem Cells?

Stem cells are the precursor cells that develop into blood, brain, bones and all of your organs. Their use in medical treatments is based on their potential to repair, restore, replace and regenerate cells that could then be used to treat many medical conditions and diseases.

Stem Cell-Based Beauty Treatments

Once stem cell-treatments gained popularity as a way to treat medical conditions and diseases, the beauty industry was quick to follow. Stem cell claims began showing up in products, cosmetic treatments like stem cell facials, facelifts and even surgical procedures where, purportedly, stem cells are separated out from fat (removed during a liposuction-like procedure) and injected into the face.

Are Stem Cell Treatments Regulated?

Stem cell-based treatments can give hope to patients with medical conditions where other treatments have failed. However, the Food and Drug Administration (FDA) is concerned that the hope that patients have for cures not yet available may leave them vulnerable to stem cell treatments that are illegal and potentially harmful.

As for the cosmetic use of stem cell-based treatments, the science behind stem cells in an aesthetic sense lags behind the marketing of these products and procedures. As of now, there are no FDA stem cell procedures or FDA-approved stem cell–extracting devices for use in the U.S.

According to a 2014 study conducted by the Stanford University Medical Center Research Team, although stem cells do hold potential for cosmetic procedures in years to come, today’s advertising claims for these procedures are going beyond any scientific evidence on safety and effectiveness. “More than 100 clinical trials are currently evaluating stem cells derived from fat, but few are focusing on cosmetic treatments. The products used in these cosmetic procedures likely involves additional types of cells unless they utilized sophisticated cell-sorting techniques.”

As many as 200 “stem cell clinics” have cropped up in recent years, offering injections, facelifts, and treatments for a number of devastating conditions. They have avoided heavy regulation, in part because they use cells extracted from a patient’s own body and because they don’t alter those cells before reinjecting them.

The Food and Drug Administration recently issued draft guidelines clarifying that the stem cells used in most clinics are drugs and require a rigorous approval process before they can be used in patients. The FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.


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