
Regenerative medicine is a broad term. It is used to describe very different treatments, including platelet-rich plasma (PRP) prepared from a patient's own blood and products derived from cells or tissue, such as stem cell or exosome products. These treatments differ in where they come from, how they are given, how much evidence exists for a given use, their risks and their regulatory status. Because of those differences, the most important step is understanding exactly what is being proposed.
Question 1: What exactly is the treatment being recommended?
Ask for the specific name of the treatment and product, where it comes from, how it is prepared and how it will be given. "Regenerative medicine" is a category, not a single treatment.
For example, PRP is plasma with a higher concentration of platelets than normal blood. The American Academy of Orthopaedic Surgeons explains that it is prepared by drawing a patient's blood and separating and concentrating the platelets in a centrifuge (AAOS OrthoInfo). Stem cell and exosome products are different from PRP and are regulated differently.
Question 2: What is the medical reason for considering it?
Ask why this treatment is being considered for your specific situation, what other options exist, and how they compare. Alternatives may include more established treatments or no treatment.
Question 3: What evidence supports this treatment for my situation?
Evidence differs by treatment and by the condition or goal being addressed. Ask what research exists for this specific treatment and use, how strong it is, and what remains uncertain. For PRP, the AAOS describes research as ongoing and notes that the evidence differs depending on the condition being treated.
Question 4: What is the product's FDA regulatory status for this use?
Ask whether the specific product is FDA-approved for the use being proposed. According to the FDA's consumer alert on regenerative medicine products:
- There are currently no FDA-approved exosome products.
- The only FDA-approved stem cell products are blood-forming stem cells derived from umbilical cord blood, approved for certain disorders that affect the production of blood.
The FDA's page on regenerative medicine therapies also explains that a product being registered with the FDA is not the same as FDA approval.
Question 5: What are the risks and limitations?
All medical treatments carry risks. Ask about side effects, less common complications, what the treatment is not expected to do and what happens if it does not help. The FDA reports that serious adverse events, including infections and blindness, have occurred with some unapproved regenerative medicine products, which is one reason to understand exactly what you would receive.
Question 6: Who will provide or supervise the treatment?
Ask who will perform the treatment, what their license and training are, and which physician oversees care. In Florida, you can check a provider's license through the Department of Health's license verification search.
Question 7: What are realistic expectations, and what does informed consent include?
Ask what outcomes, if any, are realistic for your situation, how many sessions might be suggested and how you and your provider will decide whether to continue. Informed consent should cover the nature and purpose of the treatment and the risks, burdens and expected benefits of all options, including choosing not to have treatment, as described in the American Medical Association's Code of Medical Ethics. Be cautious of any promise of a cure or a guaranteed result.
Why does a medical evaluation come first?
A medical evaluation is how a licensed provider decides whether any regenerative option may be appropriate for you, and whether another approach may be more appropriate. It considers your health history, medications, examination findings and goals, and it is the right time to ask each of the questions above. Many people who are evaluated are not candidates for a given treatment.
Regenerative medicine consultations in Ocala, FL
Synergy Health's Ocala location on State Road 200 offers consultations for patients considering regenerative care, serving Ocala, Belleview, The Villages and surrounding Marion County communities. You can review the regenerative services listed on our site, including PRP. Whether any treatment may be appropriate for you is determined by a licensed provider after an individual evaluation.
Medical Disclaimer: This content is provided for general educational and informational purposes only and is not intended as medical advice, diagnosis, or treatment. Treatment options, risks, potential benefits, eligibility, and expected outcomes vary by individual and by the specific treatment being considered. A consultation and medical evaluation are necessary to determine whether a treatment may be appropriate for you.
Frequently asked questions
Regenerative medicine is a broad term used for very different treatments, including platelet-rich plasma (PRP) prepared from a patient's own blood and products derived from cells or tissue, such as stem cell or exosome products. They differ in evidence, risks and regulatory status.
Examples include PRP, stem cell products and exosome products. According to the FDA, there are currently no FDA-approved exosome products, and the only FDA-approved stem cell products are cord blood-derived blood-forming stem cells for certain blood disorders.
No. Whether any regenerative treatment may be appropriate depends on the specific treatment, your health history, medications and goals, and is determined by a licensed provider after a medical evaluation.
Ask what the specific treatment and product are, why it is being considered for you, what evidence exists for that use, its FDA status for that use, its risks and limitations, who will provide it, and what realistic expectations look like.
Start with a medical evaluation by a licensed provider, ask the seven questions in this guide, verify the provider's Florida license, and be cautious of promises of a cure or guaranteed result.
Sources
- U.S. Food and Drug Administration, Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
- U.S. Food and Drug Administration, Important Patient and Consumer Information About Regenerative Medicine Therapies
- American Academy of Orthopaedic Surgeons (AAOS) OrthoInfo, Platelet-Rich Plasma (PRP)
- American Medical Association, Code of Medical Ethics Opinion 2.1.1: Informed Consent
- Florida Department of Health, MQA License Verification Search
External sources are provided for general reference and were reviewed in October 2026.
Explore care in Ocala.
Request a consultation at our Ocala location to ask your questions and discuss your options. Recommendations and eligibility are determined after a medical evaluation.