Regulatory explainer
Is stem cell therapy FDA-approved? FDA status and Florida law, explained
Patients hear “FDA-registered”, “FDA-compliant” and “legal in Florida” and reasonably assume those mean “approved”. They do not. This page sets out, in plain English, what the FDA has approved, what it has not, and what Florida’s 2025 law does and does not change.
Short answer
Not for pain, arthritis, injuries or cosmetic use
Short answer
No stem cell product and no exosome product is FDA-approved to treat joint pain, arthritis, back pain, tendon or ligament injuries, neuropathy or aging skin. The FDA has approved a small number of cell-based products for specific serious diseases, mostly blood and immune disorders.
Florida law (2025) allows physicians to use certain non-FDA-approved stem cell therapies for orthopedic conditions, wound care and pain management under strict conditions — but that law does not make any product FDA-approved.
PrimeCell’s physician, Kenny Chantasi, DO, performs one or more stem cell therapies that have not been approved by the FDA; that is why the Florida notice appears on this site. PrimeCell also offers exosome products in selected cases. Every patient who is offered a cellular or exosome therapy receives a written disclosure of its regulatory status and gives written informed consent first.
Three categories
Approved, off-label and investigational are different things
Every regenerative option described on primecellmed.com is labelled with one of these, for the specific use being discussed.
- FDA-approved
The FDA reviewed evidence of safety and effectiveness for a specific use and approved the product for it. Approval is use-specific: a product approved for one disease is not approved for another.
- Off-label / physician practice
A legally marketed drug or an FDA-cleared device used in a way the FDA has not specifically reviewed — for example, PRP prepared with a cleared device and injected into a tendon. Common and legal; the evidence varies by use.
- Not FDA-approved / investigational
No FDA approval for the use. Some such products are studied in registered clinical trials; others are offered in clinics. In Florida, certain stem cell therapies may be offered for limited uses under the state law described below.
What the FDA has approved
Which cell-based products are FDA-approved?
Short answer
A limited list: licensed umbilical cord blood products used in stem cell transplantation for certain blood and immune disorders, and a growing number of cellular and gene therapies for specific cancers and rare diseases. None is approved for orthopedic, pain or cosmetic use.1
The FDA keeps a public list of approved cellular and gene therapy products. It includes cord-blood-derived hematopoietic progenitor cell products used in transplantation, CAR-T and other engineered cell therapies for certain cancers, and gene therapies for inherited blood disorders.1,2 In December 2024 the FDA approved the first mesenchymal stromal cell product — for a rare complication of bone-marrow transplantation in children (steroid-refractory acute graft-versus-host disease), not for joints or pain.3
If a clinic describes a stem cell or exosome product as “FDA-approved” for your knee, back or skin, ask for the approval letter and the approved indication. You will not find one.
For a product-by-product walk through the approved list, including MACI, Ryoncil and cord blood products, and how to check a product yourself, read Which regenerative medicine products are FDA-approved?
How the FDA regulates stem cell and tissue products
Short answer
Human cell and tissue products that are only minimally manipulated and used for the same basic function they serve in the body can be marketed without premarket approval. Products that are more than minimally manipulated, or used for a different function, are regulated as drugs or biologics and need FDA approval.4
Federal rules for “human cells, tissues, and cellular and tissue-based products” (HCT/Ps, 21 CFR Part 1271) split products into two tracks. Products that meet all of the criteria for the lower-risk track — minimal manipulation, homologous use, and a few others — only need to be registered and handled under tissue-safety rules. Products that fail any criterion are regulated as biological drugs and require an approved Biologics License Application before they can be marketed for treatment.4
This is where marketing language misleads. “FDA-registered” usually means a tissue establishment is registered with the FDA — which says nothing about whether any product has been approved to treat a disease. The FDA has repeatedly warned consumers about clinics that market unapproved stem cell and exosome products, and has issued warning letters to firms selling umbilical-cord and Wharton’s-jelly products for orthopedic and other uses.5
Exosomes
Short answer
There are no FDA-approved exosome products for any medical or cosmetic use. The FDA issued a public safety notification in December 2019 after reports of serious adverse events in patients who received unapproved exosome products.6
Exosomes are tiny vesicles released by cells. In its Public Safety Notification on Exosome Products, the FDA reported multiple serious adverse events in patients in Nebraska who were treated with unapproved products marketed as containing exosomes. It stated that there are no FDA-approved exosome products, and that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products that are subject to premarket review and approval.6 The FDA’s consumer alert repeats that, as a general matter, exosome products intended to treat diseases or conditions require FDA approval.5
PrimeCell offers exosome products in selected cases, after a physician evaluation and written informed consent. They are investigational, the evidence in people is early, and you are told so in writing before you decide. Read our full explainer on exosomes.
Platelet-rich plasma (PRP)
Short answer
PRP is made from your own blood using devices the FDA has cleared for preparing it. Injecting PRP into a joint, tendon or skin is a physician-practice decision the FDA has not specifically reviewed — an off-label use, legal and common, with mixed evidence depending on the condition.
Because PRP is your own blood, prepared at the point of care, it is regulated differently from donor-tissue products. That does not mean it works for every indication; see PRP vs. stem cells for what the trials show.
Florida law
What Florida’s 2025 stem cell law does — and does not do
Florida Statutes §458.3245 (medical doctors) and §459.0127 (osteopathic physicians) took effect July 1, 2025.7
What it allows and requires
- Licensed physicians may use certain stem cell therapies that are not FDA-approved, only for orthopedic conditions, wound care and pain management
- Products must be obtained, processed and stored by facilities that meet the law’s registration and accreditation standards
- Products must contain viable (living) cells on post-thaw analysis, documented in a viability report for the product lot sent to the physician before use
- Products derived from aborted fetuses are prohibited
- The physician must obtain the patient’s written informed consent
- Advertising must carry the notice shown on this page, in type no smaller than the largest type used in the advertisement
What it does not do
- It does not make any product FDA-approved, or change a product’s federal status
- It does not establish that any therapy is effective
- It does not cover uses outside orthopedics, wound care and pain management
- It does not require insurers to pay
This summary is patient education, not legal advice. Read the statutes on the Florida Senate website: §458.3245 and §459.0127.
Aesthetic, hair & sexual health
Uses outside orthopedics, wound care and pain
Short answer
No stem cell, other cellular or exosome product is FDA-approved for cosmetic, hair-loss or sexual-health use, including erectile dysfunction. At PrimeCell these uses are investigational, and every patient receives a written disclosure saying so before deciding.
PrimeCell uses the same modalities (PRP, cellular products and exosomes) for some aesthetic, hair-loss and sexual-health concerns. For those uses:
- Cellular and exosome therapies are not FDA-approved and are investigational. PRP is used off-label.
- The evidence in people is early, and mostly from small, short studies.
- FDA-approved options are discussed first where they exist, for example minoxidil or finasteride for some types of hair loss, and PDE5-inhibitor medicines for erectile dysfunction.
- You receive, in writing, the product category and source, its regulatory status, the risks, the alternatives and an estimate before any procedure.
This page is patient education. It does not give a legal opinion on how Florida’s stem cell statute applies to these uses. Read more: regenerative aesthetics, hair restoration and sexual wellness.
How we apply it
What this means at PrimeCell
Diagnosis before product
No cellular product is discussed until Dr. Chantasi has evaluated you. Many patients are better served by rehabilitation, conventional care or PRP.
Status in writing
If a stem cell or exosome therapy is discussed, you receive the Florida disclosure where it applies, the product category and source, its regulatory status, the evidence, risks, alternatives and a written estimate — before you decide.
No approval language
We never describe a stem cell or exosome product as FDA-approved, “FDA-compliant” or proven for your condition — on this site, in the office or in advertising.
Protect yourself
Questions to ask any clinic offering stem cells or exosomes
- What exactly is the product — cells from my own body, donor birth tissue, or cell-free vesicles? Who makes it?
- Is it FDA-approved for my condition? If not, will you tell me that in writing?
- What is my diagnosis, and how was it confirmed?
- What do randomized trials show for my condition, compared with standard care?
- What are the risks, and what happens if something goes wrong?
- What is the total cost, including follow-up — and am I being asked to prepay for a package?
- Is this being offered as part of a registered clinical trial? (Check ClinicalTrials.gov.)
Questions
FDA status FAQ
Is stem cell therapy legal in the United States?
Marketing a stem cell product that requires FDA approval without that approval is not permitted under federal law, and the FDA has taken enforcement action against clinics and manufacturers. Some minimally manipulated tissue products can be used without approval. In Florida, state law since July 2025 allows physicians to use certain non-FDA-approved stem cell therapies for orthopedic, wound-care and pain uses with consent and disclosure; that does not change federal status.
What does “FDA-registered” mean?
Usually that a tissue facility is registered with the FDA. Registration is not approval and says nothing about whether a product works for a condition.
Are exosomes FDA-approved?
No. There are no FDA-approved exosome products for any medical or cosmetic use, including skin, hair, joints or pain. The FDA issued a public safety notification on exosome products in December 2019.
Does PrimeCell offer exosomes?
Yes. PrimeCell offers exosome (extracellular-vesicle) products in selected cases, after a physician evaluation and written informed consent. Exosome therapy is investigational and not FDA-approved, and the evidence in people is early.
Are cosmetic, hair or erectile-dysfunction uses of stem cells or exosomes FDA-approved?
No. No stem cell, other cellular or exosome product is FDA-approved for cosmetic, hair-loss or sexual-health use. At PrimeCell these uses are investigational and are disclosed to patients in writing.
Is PRP FDA-approved?
The devices used to prepare PRP are FDA-cleared. Using PRP for joints, tendons or skin is an off-label physician practice; its evidence depends on the condition.
Why does every PrimeCell page show a Florida notice?
Florida law requires physicians who perform stem cell therapies that are not FDA-approved to include that notice in advertising, in type no smaller than the largest type used. PrimeCell shows it throughout the site so the disclosure is never missed.
Get a straight answer about your own options.
An evaluation with Dr. Chantasi covers your diagnosis, what the evidence supports for it, each option’s regulatory status, and the cost — in writing.
$97Initial physician consultation · offer valid through October 31, 2026
THE PATIENT AND ANY OTHER PERSON RESPONSIBLE FOR PAYMENT HAS A RIGHT TO REFUSE TO PAY, CANCEL PAYMENT, OR BE REIMBURSED FOR PAYMENT FOR ANY OTHER SERVICE, EXAMINATION, OR TREATMENT THAT IS PERFORMED AS A RESULT OF AND WITHIN 72 HOURS OF RESPONDING TO THE ADVERTISEMENT FOR THE FREE, DISCOUNTED FEE, OR REDUCED FEE SERVICE, EXAMINATION, OR TREATMENT.
References
- U.S. Food and Drug Administration. Approved cellular and gene therapy products. fda.gov
- U.S. Food and Drug Administration. Important patient and consumer information about regenerative medicine therapies. fda.gov
- U.S. Food and Drug Administration. FDA approves first mesenchymal stromal cell therapy to treat steroid-refractory acute graft-versus-host disease (December 2024). fda.gov
- U.S. Food and Drug Administration. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use (guidance). fda.gov
- U.S. Food and Drug Administration. Consumer alert on regenerative medicine products including stem cells and exosomes. fda.gov
- U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Public safety notification on exosome products (December 6, 2019). fda.gov
- Florida Statutes §458.3245 and §459.0127, Stem cell therapy (2025). flsenate.gov/Laws/Statutes/2025/458.3245; flsenate.gov/Laws/Statutes/2025/459.0127
Written and medically reviewed by Kenny Chantasi, DO, on September 23, 2026. This page summarizes public regulatory information for patients; it is not legal advice. Regulatory status can change — we review this page when the FDA or Florida law changes.