Stem cells are cells that can develop into other cell types. Researchers are studying them for many conditions, but outside of specific approved uses, most applications remain investigational.

• The FDA has approved only a small number of stem cell-based products. Most are cord blood-derived blood-forming stem cell products used for certain blood and immune disorders; a few others are approved for specific serious conditions, such as one mesenchymal stromal cell product for steroid-refractory graft-versus-host disease in children. None is approved for general wellness, anti-aging, or orthopedic use. You can see FDA’s current list of approved cellular and gene therapy products on fda.gov.
• The FDA has warned consumers about unapproved stem cell products. We encourage you to read the FDA’s consumer information before considering any regenerative treatment.

If you have questions about regenerative medicine, our physician can review your history, explain what current evidence does and doesn’t show, discuss risks, and talk through established, FDA-approved alternatives.

Is this product FDA-approved or part of an FDA-regulated clinical trial? What are the risks? Where do the cells come from and how are they processed? What alternatives exist?