5 Trusted Resources That Clarify What’s Approved, What’s Not, and Why It Matters
The field of stem cell therapy is advancing fast, offering potential treatments for everything from joint pain to neurological diseases. But with that promise comes confusion, especially around what is actually FDA-approved and what isn’t.
In short, while some stem cell therapies (like hematopoietic stem cell transplants for blood disorders) are FDA-approved, most others are still considered experimental or investigational. Many clinics market unapproved therapies directly to consumers, often outside of regulated clinical trials — a practice the FDA has been cracking down on in recent years.
To help you get a clear, up-to-date understanding, we’ve rounded up trusted resources from medical institutions and government sources:
Why it’s helpful: This is the FDA’s official breakdown of how they regulate stem cell products — covering which therapies are approved, which need Investigational New Drug (IND) applications, and how enforcement is handled.
Why it’s useful: A public health warning that breaks down the risks of unauthorized stem cell treatments, with state-level support for FDA guidelines.
What you’ll learn: A clear overview of FDA-approved uses (like hematopoietic stem cell transplants) versus unapproved procedures being marketed directly to consumers.
Why it’s helpful: A practical breakdown of which stem cell therapies have been officially approved by the FDA, and what conditions they target.
What you’ll see: A great animated explainer walking viewers through how stem cells are classified, what counts as an approved product, and the importance of avoiding unregulated therapies.
Whether you’re considering treatment or simply want to understand the regulatory conversation, these resources offer a clear look at what’s approved, what’s not, and why that matters for your safety.
Are you considering stem cell treatment or regenerative therapy? Don’t make a decision without being fully informed. Download our expert-curated list of 20 critical questions will empower you to evaluate potential providers with confidence and help you decide on the best outcome for your health.
