FDA and Regulations

Not All Stem Cells Are Created Equal: What Patients Need to Know

Umbilical cord stem cells have been used medically in the United States for over 60 years, and they are currently the primary treatment for over 80 diseases, including leukemia, lymphoma, and other blood and immune disorders. They are FDA approved for many of these.

Expanding Potential: New Uses Beyond Traditional Applications

Emerging research shows promising results using umbilical cord stem cells for a wide variety of other conditions—especially those involving inflammation, such as:

• Autoimmune diseases
• Stroke
• Neurodegenerative conditions (like Alzheimer’s, Parkinson’s, MS)
• Traumatic brain injury
• Anti-aging
• Autism spectrum disorder
• Joint disorders
• Chronic pain

While many of these newer applications are not yet FDA-approved, it’s important to understand that off-label use is legal and standard in U.S. healthcare. The FDA regulates drug manufacturers—not the practice of medicine. Physicians can legally use approved biologic products (like umbilical cord stem cells) off-label when they believe it is in the best interest of the patient.