What Questions Should You Ask Before Trying Regenerative Medicine?

Before starting any regenerative medicine therapy, ask whether the specific product has FDA approval or is being used off-label or investigationally, who is administering it and under what license, what the published evidence actually shows for your condition, and what the total cost will be since most regenerative options are not covered by insurance. A licensed physician should be able to answer each question directly and specifically, not in vague marketing language.

What This Means

Regenerative medicine covers a wide range of products and procedures — from FDA-approved options like certain cleared devices and hematopoietic stem cell transplants, to widely marketed but non-FDA-approved products such as most stem cell, exosome, and amniotic-tissue injections (FDA, 2024). The term itself does not tell a patient much; the same phrase describes an approved bone marrow transplant for leukemia and an unregulated injection sold online for joint pain. That gap is why asking direct, specific questions before starting care matters more in this field than in most areas of medicine.

Candidacy

There is no single candidacy checklist for “regenerative medicine” because it is not one therapy — candidacy depends entirely on which specific product or procedure is being proposed, for which condition, and under what regulatory pathway. A patient considering an FDA-approved option faces a different risk-benefit conversation than a patient considering an unapproved stem cell or exosome injection marketed for a condition like osteoarthritis or a neurologic disorder, which the FDA has explicitly stated it has not approved for any orthopedic or neurological use (FDA, 2024). Anyone considering a regenerative product should ask, up front, which category their proposed option falls into.

Clinical Evaluation

A thorough evaluation should include a physical exam, review of imaging or prior history, and a candid conversation about what is and is not FDA-approved for the condition being discussed. Patients should ask the provider to name the manufacturer of any biologic product, request documentation such as a Certificate of Analysis, and ask whether the product is being used under an FDA Investigational New Drug application or a registered clinical trial — a legitimate research pathway that differs meaningfully from a product sold directly to consumers outside of any trial oversight (FDA, 2024).

Available Options

Depending on the condition, mainstream and conventional alternatives typically exist alongside regenerative options: physical therapy, corticosteroid or hyaluronic acid injections, bracing, prescription medication, and, in appropriate cases, surgery. For conditions where regenerative products carry the least evidence, these established options often carry a longer track record and more predictable insurance coverage. A second opinion from a specialist who does not offer regenerative products can help patients weigh the full range of choices without a financial incentive tied to a specific option.

Benefits, Limitations and Risks

Patients should ask directly what risks are specific to the product being proposed, not just generic reassurance about safety. Documented risks tied to unapproved regenerative products include bacterial and fungal bloodstream infections traced to contaminated manufacturing, and other serious adverse events reported to the FDA (Pew Charitable Trusts, 2021). Because many of these products are biologic materials that cannot be sterilized after collection without destroying their intended activity, contamination introduced during processing can carry directly through to the patient. Patients should also ask what happens, and who is responsible, if a complication occurs afterward.

What the Evidence Shows

The evidence does establish that regenerative biology — the way stem cells, growth factors, and related molecules interact with injured tissue — is a real and active area of legitimate research, and that a small number of regenerative products have cleared FDA review for specific, narrow indications. Independent market research also documents that pricing for regenerative and orthobiologic injections varies substantially between practices and is rarely standardized or covered by insurance (Khan et al., 2025; Tauro et al., 2025).

What the evidence does not establish is that most of the products marketed broadly as “regenerative medicine” for joint pain, aesthetics, or systemic conditions have been shown, in adequately controlled trials, to be safe and effective for those specific uses (FDA, 2024). Patients should ask a provider to point to the specific study behind a specific claim, rather than accepting general references to “the research.”

Recovery / Next Steps

Ask what recovery and follow-up look like for the specific product proposed: expected downtime, what side effects are normal versus concerning, and when to call the office. Ask whether the practice tracks and reports outcomes, and whether it would report an adverse event to the FDA's MedWatch program if one occurred (FDA, 2024). A provider who cannot describe a follow-up plan in specific terms has not fully thought through the option either.

Orlando Considerations

Florida law regulates who may administer certain stem cell and regenerative products and under what conditions, most recently through Fla. Stat. § 458.3245 (2025), which sets requirements for physician oversight of these products. Patients in the Orlando area should ask whether the physician offering care is licensed in Florida, whether the specific product and procedure fall under this statute, and whether the practice can explain how it complies with it.

Frequently Asked Questions

What is the single most important question to ask before starting a regenerative medicine option?

Ask whether the specific product has FDA approval for your specific condition, or whether it is being used off-label, investigationally, or outside of any approved pathway. That answer changes the entire risk-benefit conversation (FDA, 2024).

Should I ask about cost before starting?

Yes. Most regenerative and orthobiologic options are not covered by insurance, and published research shows pricing varies widely between practices for similar products, so getting a specific, written cost estimate in advance is reasonable (Khan et al., 2025; Tauro et al., 2025).

How do I know if a provider is qualified to perform a regenerative procedure?

Ask about the provider's license, specific training in the procedure being offered, and how many times they have performed it. In Florida, ask specifically how the practice complies with state stem cell therapy requirements (Fla. Stat. § 458.3245, 2025).

Is it reasonable to ask for a second opinion?

Yes. A second opinion from a physician who does not offer the regenerative product in question can help confirm whether it is an appropriate option relative to conventional alternatives, without a financial incentive tied to a specific option.

What should I do if I already had a regenerative procedure and I'm having problems?

Contact the physician who performed it promptly, and consider reporting the issue to the FDA's MedWatch Adverse Event Reporting program, which tracks safety problems tied to these products (FDA, 2024).

This article is for general patient education and does not replace an individualized medical evaluation. Regenerative medicine products discussed here are investigational or unapproved outside of FDA-cleared indications, and outcomes vary by patient and condition. A licensed physician should evaluate your specific history before any decision about care.

Medically reviewed by Kenny Chantasi, DO.

References

Centers for Medicare & Medicaid Services. (n.d.). National coverage determination (NCD) for stem cell transplantation (110.23). CMS.gov. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=366

Fla. Stat. § 458.3245 (2025). Stem cell therapy. Florida Senate. https://www.flsenate.gov/Laws/Statutes/2025/458.3245

Food and Drug Administration, Center for Biologics Evaluation and Research. (2024, April 9). Consumer alert on regenerative medicine products including stem cells and exosomes. FDA. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes

Khan, Z. A., Kaplan, D. J., Hevesi, M., Dasari, S. P., Kerzner, B., Fortier, L. M., Jackson, G. R., Brusalis, C. M., Yanke, A. B., Chahla, J., Cole, B. J., & Verma, N. N. (2025). The availability and pricing of orthobiologic knee injections in the Chicago metropolitan area: A market assessment study. Orthopaedic Journal of Sports Medicine. https://doi.org/10.1177/23259671241310452

Mayo Clinic Staff. (n.d.). Stem cells: What they are and what they do. Mayo Clinic. https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117

Tauro, T. M., Hershfeld, B., Chen, K., Lampert, R., Bitterman, A. D., Cohn, R. M., & Sgaglione, N. A. (2025). Availability and pricing of orthobiologic knee injections vary by practice type but not by community socioeconomic vulnerability in suburban New York. Arthroscopy, Sports Medicine, and Rehabilitation. https://doi.org/10.1002/ars2.70074

The Pew Charitable Trusts. (2021, June 7). Harms linked to unapproved stem cell interventions highlight need for greater FDA enforcement. https://www.pew.org/en/research-and-analysis/issue-briefs/2021/06/harms-linked-to-unapproved-stem-cell-interventions-highlight-need-for-greater-fda-enforcement

Last medically reviewed: September 16, 2026

Related reading

• How to Compare Orlando Regenerative Clinics
• How Do You Know If You're a Good Candidate for Regenerative Medicine?
• Is Regenerative Medicine Covered by Insurance?
• What Are the Risks of Regenerative Medicine?

More questions answered on the PrimeCell patient blog, or see frequently asked questions.

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PrimeCell is a physician-led practice in Orlando. Candidacy for any procedure is determined at an in-person evaluation.