Stem Cell Therapy Cost in USA 2025

We look Stem Cell therapy costs in the USA, what’s legal and the latest developments. Hope this helps!

How much does Stem Cell Therapy cost in USA?

From Patients we’ve interviewed, Bone Marrow or Fat derived Stem cell treatments for joint pain or arthritis in the USA is around $7,000 per joint. It can go up to $10,000. 

Costs will vary from state to state. For example we’ve got more details on costs in Utah specifically below. We’re getting more data on costs in Florida specifically too, bear with us!There are facilities that do treatments for non approved treatments like Diabetes, auto immune conditions etc and those costs will vary wildly.

Also, very few clinics have prices on their website in the US, we know it’s frustrating!

Does Medicare in the US cover Stem Cell treatments?

Medicare covers your stem cell treatment only if it’s an FDA-approved hematopoietic transplant for a qualifying blood or immune disorder. (you can read more on the official website of the Centers for Medicare & Medicaid Services)

Unfortunately, other types of stem cell procedures are not covered. You have to pay all costs yourself!

Is Stem Cell Therapy FDA Approved?

The only stem cell treatments currently approved by the FDA are those that use hematopoietic stem cells (derived from bone marrow, peripheral blood, or umbilical cord blood) for treating blood-related cancers and immune disorders. 

These treatments have gone through clinical trials and received a Biologics License Application (BLA) from the FDA, making them legal and available in clinical practice.

This PDF goes into the FDA’a official stance on stem cell treatments. We know there’s a lot going around now in terms of what’s legal and what’s not, we’re breaking it down for you below.

What Stem Cell Treatments are Illegal in the USA

All other types of stem cell treatments, including those that isolate, culture, or expand stem or stromal cells, are regulated as drugs or biological products.

Basically treatments that separate stem cells and grow them are not allowed.

Offering these treatments without FDA review is illegal. The FDA has enforced this position with warning letters, injunctions, and court rulings. But there are exceptions for certain states, as you’ll find out below.

Can Clinics in the US offer Stem Cell Treatments?

Yes, there is one notable exception for certain treatments performed in the same surgical procedure:

According to 21 CFR 1271.15(b), stem cell treatments do not require FDA review if:

• The patient’s own tissue (or cells) is removed and re-implanted in the same patient,
  
• The procedure occurs within the same surgical session,
  
• The tissue is only minimally manipulated (no isolation or expansion), and
  
• The use is homologous, meaning the tissue’s intended role is the same in the recipient .
  

The FDA has stated that this exception applies only when tissue is used “in its original form, with minimal processing”.

So if your treatment includes taking the stem cells from your own body & re-injecting them straight away, it’s OK.

In Summary:

• Legal: FDA‑approved hematopoietic stem cell treatments for certain cancers and immune conditions.
  
• Potentially Legal: Autologous, minimally manipulated, homologous tissue administered in the same surgical procedure (21 CFR 1271.15(b)).
  
• Illegal Without IND/BLA: All other stem cell treatments that do not qualify for the “same surgical procedure” exception.

Are Stem Cell Treatments legal in Florida now (July 2025)

In Florida, the rules for stem cell therapy changed in 2025. The state passed Senate Bill 1768, which goes into effect on July 1, 2025, making it legal for licensed doctors to use certain stem cell treatments. (Source: Florida CS/CS/SB 1768 Final Enrolled Text).

Here’s what this means:

Allowed Stem Cell Treatments in Florida

Umbilical Cord‑Derived Treatments with Higher Cell Counts:

• A doctor can use stem cell products derived from FDA‑registered, accredited by recognized entities (such as AABB or NMDP), providing properly processed stem cell products
• This means treatments using lab‑prepared mesenchymal stem cells (often from umbilical cord tissue, Wharton’s Jelly, amniotic fluid, or other accredited tissue sources) can be administered in a clinical setting. 
• As long as it’s for orthopedic, pain, or wound care.
• There’s no set dose limit in Florida’s new law. Doctors can use as many stem cells as needed, as long as the product comes from an FDA‑registered facility and is used as intended.
• Patients must sign an informed consent that clearly explains the therapy is investigational and not FDA‑approved.
• Advertising must clearly state that the therapy is “Not FDA‑Approved”.
• The doctor must adhere to Good Manufacturing Practices (GMP) and only use products from vetted, accredited suppliers.

Autologous Treatments:

• If a doctor takes your own stem cells (for example, from bone marrow or fat) and uses them in the same procedure with only minimal processing like washing or centrifugation,  this also remains legal.

Illegal Stem Cell Treatments in Florida

• Growing or culturing stem cells in the doctor’s office.
• Using embryonic or fetal tissue‑derived products.
• Making or manipulating cellular products beyond “minimal” steps (without an IND or BLA from the FDA).
• Treatments in categories like these are still banned: Diabetes, Parkinson’s disease, Autism, Multiple sclerosis, Stroke recovery, Alzheimer’s, Hair loss etc.

Stem Cell Treatment Costs in Florida

We don’t want to just give you a generic range here. We’re gathering our data from patients & clinics who will be following the new regulations, so bear with us here!

Stem Cell Therapy in Nevada

In Nevada, Senate Bill 128 (2025) introduced a new requirement for doctors treating certain patients. According to the official text of the law:

“Sections 9-11 of this bill require a physician, physician assistant, advanced practice registered nurse or an osteopathic physician to: (1) discuss with a patient, upon diagnosing the patient with arthritis, osteoarthritis or any other condition that is regularly treated using stem cell therapy, the potential use of stem cell therapy to treat the condition; and (2) when acting as a provider of primary care during the first encounter with a new patient, inform the patient of options that may be available to the patient for donating, banking or storing stem cells for future use by the patient or a donee.” (SB128 Final Enrolled Text, Section 9, lines 15–21)

In simple terms, this means if you have a condition like arthritis (or any other issue commonly treated with stem cell therapy), your doctor is required to tell you about stem cell therapy as an option when making the diagnosis.

Right now, Nevada’s focus is on education and patient awareness. Making sure doctors talk to patients about stem cell therapy where it applies. 

The actual laws about providing treatments haven’t changed. Stem cell treatments in Nevada still have to follow federal FDA rules, just like everywhere else in the US (same‑day, minimally manipulated procedures only).

Don’t be surprised if laws around regenerative medicine change in upcoming months in Nevada!

Stem Cell treatments in Utah

In Utah, House Bill 376 (2024) introduced new rules for certain stem cell treatments. According to the official text of the law:

“A health care provider whose scope of practice includes the use of stem cell therapy may perform a stem cell therapy that is not approved by the United States Food and Drug Administration, if the health care provider provides the patient with the following written notice before performing the therapy:”THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your  primary care provider before undergoing a stem cell therapy.” (HB376 Final Text, lines  32–39)

Basically, if you’re seeing a doctor in Utah who uses placental tissue treatments (such as those derived from the placenta or umbilical cord), they can offer these treatments even if the FDA hasn’t approved them. As long as they clearly tell you this in writing and post the notice where patients can see it.

Now nothing in the bill is restricting these stem cell treatments to any condition. So again, as long as they state it’s experimentantal & tell you, it looks like clinics here are allowed to offer treatments outside of joint pain & wound care. This does seem like a bit of a grey area.

BUT, doctors can only use placental or umbilical cord stem cells if they get them from an FDA‑registered, accredited lab. They can’t just grow or culture the cells themselves.

Stem Cell Therapy Costs in Utah

From speaking to patients & clinics in Utah, stem cell therapy for orthopaedic issues costs around $5,000 – $7,000 per joint. Some clinics will offer discounts for multiple joints or follow on treatments too.

Where can I legally get Umbilical Cord Derived Stem Cell Treatment in America?

State	Umbilical Cord Cells Allowed?	High Cell Dosages?
Utah	Yes	Yes (if sourced from an FDA-accredited lab)
Florida	Yes	Yes (if sourced from an FDA-accredited lab)
Nevada	No	No

What Do US Clinics Mean When They Say “Off‑Label Use is Legal”?

Bear with us here, it gets a bit tricky.

“Off‑label” applies only when a doctor prescribes an FDA‑approved therapy for an indication that is not in its labeling. According to the FDA:

“From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.” (FDA.gov: Understanding Unapproved Use of Approved Products)

However, when it comes to stem cell treatments, the FDA clearly states:

“Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the “hematopoietic” system) but they are not approved for other uses.”  (FDA.gov:Important Patient and Consumer Information About Regenerative Medicine Therapies )

In simple terms, Off‑label means a doctor can use a therapy that the FDA has already approved for one condition to treat a different condition. This is common in medicine. For example, using an approved drug for another illness.

But with stem cell treatments, most aren’t FDA‑approved at all. So when a clinic talks about “off‑label” use for umbilical cord derived stem cells, that doesn’t apply. These treatments aren’t “off‑label”, they’re unapproved and must go through the FDA’s IND or BLA process.

What other countries offer Stem Cell Treatments outside of the US?

Other popular countries include Mexico, Panama, Colombia, Japan & South Korea. Mexico is definitely the cheapest, but has the shadiest reputation. Colombia & Panama are great options as they’re close by and if you’re working with the right clinics, you can be safe.

Japan & South Korea are quite a bit further away but Stem Cell treatments in these countries are much more regulated & considered safer. They’re also not that much more expensive either. South East Asia is also leading the way with research in this area, by a long shot. We’ve put together articles covering Colombia, Japan & South Korea.

Is America a good destination for Stem Cell treatments, quality & cost wise?

Depending on what treatment you’re looking for, Florida & Utah might be decent options & with orthopaedic conditions ranging between $5,000 – $10,000, you won’t be breaking the bank. (Florida may be slightly higher, we’re still double checking here!)

The US stem cell scene can be a bit of a Wild West. Most clinics operate under “same‑day” rules with no cell isolation, so it’s nearly impossible to know how many viable MSCs you’re actually getting, or how high‑quality the product is. 

Some even use “off‑the‑shelf” terms to confuse patients or bend the rules altogether, making it a gamble.

 So if you’re dealing with a joint or orthopedic issue, Florida or Utah can be solid choices. But for other conditions, you’re often better off looking beyond the US. 

But remember, we’re not saying all clinics are equal in these regions. It’s still super important to pick the right clinics operating in the right way.