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Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
Part of U.S. Food and Drug Administration
USOfficial or government body
This describes who publishes a source, not how reliable it is.
Open source (opens in a new tab)Link checked August 2026
About this source
The US regulator's consumer alert on stem cell and exosome products, listing the conditions, including ALS, for which no such product is approved, and warning that unapproved products may be illegally marketed and unsafe.
Where this source is used
Used in 2 places across 1 domain.
Questions
Research & Trials
Clinical Trials
- How do I avoid false hope and trial-related scams?
Adds context
“Stem cell treatments sold by private clinics are largely unapproved and unproven, the costs can be very large, and they carry real risks of harm.”
Adds the ALS-specific fact, for one country. The US regulator names ALS among the neurological conditions no stem cell or exosome product is approved to treat, and says such products are sometimes illegally marketed and can carry safety issues that put patients at risk. It speaks only for the United States.
None of these products have been approved to treat any neurological disorder, such as multiple sclerosis, amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease), Alzheimer’s disease, Parkinson’s disease, epilepsy, or stroke.
Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
Emerging Therapies
- What about unproven treatments, "stem cell" clinics, and paying for access?
Adds context
“Outside a short list of long-established uses, stem cell treatments are still experimental, and in the United States no stem cell product is approved for ALS/MND.”
The US regulator names ALS among the neurological conditions for which no stem cell or exosome product is approved, and warns that products of this kind are sometimes marketed illegally and can put people at risk. It speaks only for the United States.
None of these products have been approved to treat any neurological disorder, such as multiple sclerosis, amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease), Alzheimer's disease, Parkinson's disease, epilepsy, or stroke.
Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
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