How to Evaluate a Regenerative Medicine Clinic: A Framework for Patients

Much of what matters about a clinic can be checked from home before you book anything: whether its product can legally be offered outside a clinical trial, whether the physician’s license is clean and their certification real, whether the clinic appears in FDA enforcement records, what its own website claims and on what evidence, and whether it will put the product, the paperwork and the price in writing.

A clinic can pass every check and still sell a treatment with weak evidence; for knee and hip arthritis, the main rheumatology guideline recommends against stem cell and platelet-rich plasma injections. The checks identify regulatory or credibility problems before you spend money. They do not make the treatment work. What the evidence shows for your condition is covered on the pages about who is a reasonable candidate and on each joint page. Once you are in the room, the questions for your first consultation take over.

1. Can this product legally be offered outside a clinical trial?

Write down, in plain words, what the clinic says it injects: your blood (PRP), your bone marrow, your fat, or a donor product. Federal rules leave two narrow paths without FDA approval: cells taken from you and put back during the same surgical procedure, and minimally processed tissue used for the same basic job it did in the body. Everything else needs FDA authorization to be tested and approval to be sold. The rules and the court rulings behind them are set out under what stem cell therapy is and where the FDA stands. The check itself looks like this:

Sources for the table: FDA list; FDA; FDA warning, May 11, 2026.

Related pages: what is being studied.

Only a lawyer can judge whether a specific protocol fits the rules; this page cannot.

2. Who holds the needle, and is their record clean?

A clinic’s website may name a medical director; the person who does your procedure may be someone else. Look up the name you have, then plan to confirm the rest at the visit.

• License and discipline. In Tennessee, the Department of Health’s licensure verification search shows license status and, where there is one, the disciplinary profile. Other states run similar searches through their medical boards.
• Board certification. The American Board of Medical Specialties lets you check certification at Certification Matters. None of its 24 member boards is a stem cell or regenerative medicine board (Certification Matters board list), so a certificate with “regenerative” in its name comes from outside that system.

How to read a physician’s training, including osteopathic boards and the “board eligible” label, is part of checking a specialist’s credentials.

3. Has the clinic come up in enforcement records?

Search the clinic’s name, and the name of any product it sells, in the FDA’s searchable warning letter database. A hit is a reason to read the letter, not an automatic verdict; the FDA notes that “Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter” (FDA, above).

Marketing claims can also end in court. In January 2025 the Federal Trade Commission announced court orders banning the co-founders of one stem cell marketing network from selling regenerative treatments and requiring more than $5.1 million in refunds and penalties, after it alleged false claims about the treatments’ effectiveness and approval (FTC). Clinics are not always the named party in these cases. When the FTC first sued in 2021, it described the defendants as a company that trained and supplied other clinics (FTC, 2021), so a clinic’s name may not appear even when its methods came from the company that was sued.

4. What does the clinic’s own material claim, and can you trace it?

Read the website the way you would read a study. The International Society for Stem Cell Research lists warning signs of unproven treatments, including heavy reliance on patient testimonials, one cell type marketed for many unrelated diseases, claims that a treatment carries no risk, and claims that regulatory approval is not needed (<a href="https://static1.squarespace.com/static/611faaa8fee682525ee16489/t/65f09b1918aebc21ebd37efe/1710267161381/ISSCRPatientHandbookv12Feb2024Redesignv4b.pdf”>ISSCR Guide to Stem Cell Treatments, 2024).

Three things are worth sorting as you read:

• Is the claim about pain, or about the joint itself? “Relieves pain” and “regenerates cartilage” are different promises. The second has not been shown in people; no study in the main Cochrane review of knee stem cell trials measured whether the joint changed on X-ray (<a href="https://www.cochrane.org/evidence/CD013342what-are-benefits-and-risks-stem-cell-injections-knee-osteoarthritis”>Cochrane).
• Does a number have a source? A percentage with no study attached cannot be checked. A cited study can: look at who was in it and what they were compared with.
• Does the site mention the evidence against? For knee and hip arthritis, the American College of Rheumatology and Arthritis Foundation guideline recommends against stem cell and platelet-rich plasma injections (ACR). A clinic that says so on its own site is showing you something about how it communicates.

Urgency, “FDA-registered” and the other persuasion patterns are among the warning signs that should end a consultation.

5. Will the clinic put the product, the paperwork and the price in writing?

Before a visit, email the clinic and ask for four documents. How it responds is part of the check.

• A written description of the product: its source, where it is prepared, and how long it sits between collection and injection. Where processing happens is not, by itself, a sign of quality; what matters is whether the clinic can document what was in your syringe. Knowing what such a report can and cannot contain, from cell counts, viability and documentation, keeps the request realistic.
• A blank copy of its consent form, so you can read it at home. A line-by-line checklist for informed consent includes whether the clinician profits from the product.
• A written price covering the consultation and imaging, the harvest, processing and each injection, any repeat injection the clinic expects to recommend, follow-up visits, what you pay if the sample on the day is not usable, and the refund policy. Unusually high costs and hidden expenses are on the ISSCR’s list of warning signs (ISSCR, above). Whether insurance pays for any of it is a separate question about insurance and regenerative medicine.
• How the needle will be guided. Imaging can improve placement accuracy without proving that the treatment itself works, and ultrasound and fluoroscopy are used for different targets.

Before you book

By the end of the desk check you should know what the clinic injects and whether that product can legally be sold outside a trial, whose license you looked up and what it showed, whether the clinic or its products appear in enforcement records, which of its claims you could trace to a study, and whether it sent the documents you asked for. A failure on the first check is a reason not to proceed with that proposed treatment. A clinic with gaps in the others is not necessarily dishonest, but those gaps are what the first visit has to fill, and staying with the treatments your own doctor already offers remains one of your options.

This page is general information, not medical or legal advice.