What is legal when it comes to stem cell therapy in regenerative medicine?
Welcome back! In our last post, we explored how stem cells treat joint pain. Today let’s talk about what’s actually legal!
What is legal when it comes to stem cell therapy in regenerative medicine?
You’ve probably heard the buzz.
Stem cells are being talked about everywhere—on billboards, in doctor’s offices, on podcasts, even in your Facebook feed. Promises of pain relief, healing, and “regeneration” sound exciting.
But here’s the honest question most people don’t ask: What’s actually legal when it comes to stem cell therapy in the U.S.? The answer might surprise you.
What the FDA Actually Approves
In the United States, stem cell therapies are regulated by the FDA, just like any other drug or medical procedure. That means they must be tested, proven to work, and shown to be safe before they can be approved for general use.
So far, the only stem cell therapies the FDA has approved are for treatments related to certain types of cancer, like leukemia and lymphoma. That’s it.
There are no FDA-approved stem cell therapies for:
- Joint pain
- Arthritis
- Back problems
- Alzheimer’s
- Diabetes
- Long COVID
- Autism
- Any orthopedic or autoimmune condition
- Already in FDA-approved clinical trials, and
- Manufactured using FDA-compliant methods
- Already have completed their Phase 1 Safety Study
- Longevity
If someone tells you otherwise, they’re not telling you the full story.
How PSC Is Different
At Personalized Stem Cells (PSC), we believe the right path is the one that protects patients and advances real science.We don’t skip steps or cut corners. We work with your physician and follow FDA-approved clinical trial protocols. Your stem cells are processed in clean, compliant labs with decades of experience in regenerative medicine.We don’t guess—we gather data.
We don’t market shortcuts—we offer real, regulated hope.Yes, There Is a Legal Way to Help Patients—It's Called Right to Try
Some patients can’t wait years for full FDA approval. That’s why PSC also uses the Federal Right to Try Act—a national law that allows patients with serious or life-threatening conditions to try experimental therapies that are:This program gives hope to patients who have no other good options. But it only applies to companies like PSC—those who are following the proper FDA pathways.
Billboard clinics can’t offer Right to Try. They haven’t done the science or followed the rules. We have.
It’s not a shortcut—it’s a safety valve. And it’s legal, ethical, and patient-focused.
What You Should Know as a Patient
Here are a few questions to ask if you’re considering stem cell therapy:
- Is this treatment part of an FDA-approved clinical trial?
- Can the provider show you published data or real-world results?
- Do they explain how your cells are processed and stored?
Be careful with any provider who promises fast results, miracle cures, or says things like, “It’s legal here, even if not FDA approved.”
That’s a red flag.
Your Health Deserves the Truth
Stem cells may change the future of medicine—but that future has to be built the right way: with real science, patient safety, and trust.
At PSC, we’re working every day to make stem cell therapy not just possible—but legal, safe, and effective for the people who need it most.
Because you only get one body. And we’re here to help you protect it.
What This Means for You
You Don’t Have to Keep Living with a debilitating condition.
If you’re looking for a natural way to approach your condition—your own stem cells could be the answer.
We invite you to talk with our Patient Concierge, Corbyn, who can help you understand your options and answer your questions. Once you have the lay of the land, Corbyn can organize a conversation with our medical director or an affiliate orthopedic specialist about your specific conditions and options.
Stay tuned for our next post, where we’ll explore specifically how your small sample of fat can be expanded into many doses of stem cells for use now and in the future.
Common Questions
Once banked through our StemReady™ program, your stem cells are cryopreserved and securely stored, ready for use when you and your physician decide. While not all therapies are commercially available yet, you may qualify for programs like the FDA's compassionate use or the Federal Right-to-Try Act if you have a life-threatening or debilitating condition.
Ask our team how you may qualify.
The cost of our services at Personalized Stem Cells varies depending on the specific treatment plan and stem cell banking options you choose.
Here are the general starting points for PSC services:
- StemPreserve: Starting at $2,500 plus an annual banking fee.
- StemReady: Prices begin at $12,500, which includes preparation of cells for immediate use.
These are your initial costs and do not include any additional fees that your doctor may charge to perform the lipoaspiration or treatment. For a detailed breakdown and to discuss payment options, please contact our customer service team. We're committed to providing transparent and comprehensive pricing information.
Getting started with stem cell banking at PSC is easy. Simply schedule a consultation through our website or contact our team directly. We’ll guide you through the entire process, from the initial collection of your cells to their long-term storage, ensuring you have all the information you need to make an informed decision. Schedule a consultation here.
PSC’s cell therapies are currently being investigated through formal FDA clinical trials with leading scientists and institutions. PSC has completed its first safety and efficacy study and submitted the findings to the FDA. Until formal FDA approval is obtained, PSC cannot make specific claims about this therapy. However, our initial safety and efficacy study is available upon request and has been published in a peer-reviewed journal.
PSC adheres to stringent FDA guidelines to guarantee the safety and quality of your stored stem cells. Our state-of-the-art lab utilizes advanced processing techniques to ensure that your cells are preserved at the highest standards. Every batch of stem cells is tested for sterility and purity.
