Before paying, identify the exact product and procedure, ask whether the U.S. Food and Drug Administration (FDA) has approved that product for your condition and intended use, and demand written evidence for every claim. If the offer is investigational, obtain the clinical-trial details, FDA-issued Investigational New Drug (IND) number and FDA acknowledgment, and read the consent form before committing. Have the patient’s regular clinician review the proposal, alternatives, risks and timing.
“Regenerative medicine” is a marketing category, not a single legal status. Stem-cell products, exosomes, fat-derived products, stromal vascular fraction and umbilical-cord products can be regulated differently depending on what they are, how they are processed and what the clinic intends to do with them.
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Start by pinning down exactly what the clinic is selling
Do not accept a description such as “your own cells,” “biologic repair,” or “FDA compliant.” Ask for the product’s exact name, source, composition and route of administration in writing. A clinic should be able to state whether it proposes a stem-cell product, exosome product, stromal vascular fraction, fat-derived preparation, umbilical-cord product or another human-cell or tissue product.
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Ask these identity questions
- What is the product’s complete name and source?
- Are the cells or materials autologous (taken from the patient) or allogeneic (from a donor)?
- Where are they collected, processed, stored and tested?
- Is anything added, expanded, cultured, genetically modified or combined with another substance?
- How is the product delivered: injection, infusion, implantation, surgery or another procedure?
- What dose, number of administrations and treatment schedule are proposed?
Request the actual patient-facing documents, not only a slide deck or sales call. The identity of the product determines which approval, manufacturing and safety questions apply.
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Define the condition and intended use
Write down the diagnosis, body site, symptoms and specific outcome the clinic says it is treating. “For arthritis,” “for aging,” or “for immune support” is too broad to establish an approved use. Ask whether the product is FDA-approved for this exact condition, route, dose and patient population. Request the approval source and the approved labeling rather than accepting a claim that the clinic, facility or product is “FDA registered.”
Separate FDA approval from registration, listing and trial enrollment
FDA approval attaches to a particular product and use. A clinic’s registration, a product listing or an entry on ClinicalTrials.gov does not by itself authorize marketing or prove that treatment is safe or effective. FDA specifically warns that inclusion in ClinicalTrials.gov, or a firm’s registration or listing of a product with FDA, does not mean the product is legally marketed.
| What the clinic may say | What it actually establishes | What to request |
|---|---|---|
| “FDA registered” or “FDA listed” | Registration or listing alone does not establish approval or legal marketing. | The FDA approval number and labeling for the exact product and indication, if the clinic claims approval. |
| “ClinicalTrials.gov trial” | A registry entry does not prove FDA approval, efficacy or permission to sell treatment outside the study. | The trial name, sponsor, investigator, site, protocol and consent form. |
| “Investigational treatment” | The product is being studied and is not established as an approved treatment for that use. | The FDA-issued IND number, FDA communication acknowledging the IND and complete informed-consent documents. |
| “FDA compliant” or “under FDA oversight” | A broad marketing phrase that does not identify the product’s legal status. | A precise explanation of the FDA pathway and documents supporting it. |
What FDA’s current consumer guidance says
FDA’s consumer information dated June 3, 2021 states: “Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally.” That warning concerns the products and circumstances covered by that guidance; it is not a ruling that every service described as regenerative medicine has the same status. Ask the clinic to identify the exact product and legal basis for the proposed use.
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If the offer is investigational, verify the trial before paying
A legitimate study should be transparent about who is responsible for the research, what participants will receive and what protections apply. An investigational label is not proof of benefit or a guarantee of safety.
- Ask for the trial’s identity. Obtain the official study name, protocol or registration number, sponsor, principal investigator and the specific clinic location. Confirm that the proposed procedure and product match the study description.
- Request the FDA-issued IND number. FDA’s December 9, 2019 public safety alert advises patients considering an exosome investigation to ask for the FDA-issued IND number and the opportunity to review the FDA communication acknowledging the IND.
- Read the acknowledgment, not a substitute document. An IND number shows that a regulatory submission exists; it does not prove efficacy, guarantee safety or authorize the clinic to make promotional claims. Ask what the acknowledgment covers and whether it covers the product, dose, route and condition being offered.
- Read the informed-consent form before making a payment. It should explain that the product is investigational, the known and unknown risks, procedures, alternatives, compensation or treatment for research injury, privacy, withdrawal rights and whom to contact with concerns. Take the form home and discuss it with the patient’s own clinician.
- Confirm who provides independent oversight. Ask for the reviewing institutional review board or ethics committee and how adverse events are handled. If the clinic refuses to provide basic trial documents, pause rather than relying on verbal assurances.
Test the evidence for this condition and procedure
Evidence must match the exact product, dose, route, diagnosis and outcome. A laboratory result, animal experiment, testimonial or study of a different cell preparation cannot establish that the clinic’s proposed procedure works for you.
Questions about benefit
- What peer-reviewed human studies used this same product and procedure for this condition?
- How many participants were studied, and was there a comparison group?
- What benefits were measured, over what follow-up period, and how often did participants fail to improve?
- Which findings are established, and which remain uncertain?
- Does the clinic have data on repeat treatments, long-term outcomes and people who experienced complications?
Ask for full publications or study identifiers so your clinician can review them. A clinic’s success percentage without a defined denominator, follow-up period and outcome measure is not enough to estimate your chance of benefit.
Understand potential harms and the response plan
FDA has described serious potential harms associated with unapproved human-cell and tissue products. Reported or identified concerns include blindness, tumor formation, neurological events, bacterial infections including serious bloodstream infections, reactions at the collection or administration site, unwanted immune or inflammatory responses, cells moving or growing in unintended ways and contamination. These are potential hazards for a broad class of products, not a prediction of what will happen to a particular patient; the actual risk depends on the product and procedure.
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Ask how the clinic controls and responds to risk
- What testing is performed for sterility, identity, potency, contaminants and donor eligibility?
- How are the product and the procedure monitored during and after treatment?
- Which complications have occurred with this product, at this clinic and in published studies?
- Who provides urgent care if symptoms develop after you leave?
- Which hospital or specialist receives referrals for infection, neurological symptoms, vision changes, severe pain or other emergencies?
- What records will you receive, including lot or batch information, dose, date and provider?
FDA’s 2025 warning described complaints and adverse events involving unapproved human-cell or tissue products, including reported deaths. FDA cautioned that it could not establish causation in every report; in one case, direct testing of the administered product was not feasible. This is why product identification and complete records matter if a problem occurs.
Protect established treatment and get an independent medical view
Ask what established treatments you might delay, stop or become ineligible for by choosing the clinic’s offer. The relevant comparison includes approved medicines, surgery, physical therapy, rehabilitation, watchful waiting, palliative care and properly conducted clinical trials, depending on the diagnosis.
Give the patient’s regular clinician the written proposal, consent form, evidence and cost agreement. Ask whether delaying standard care could worsen the condition, reduce future options or affect eligibility for another trial. An independent clinician can also check whether the proposed procedure conflicts with medications, surgery plans, pregnancy, immune conditions or other health factors.
Check the clinician, facility and chain of responsibility
Ask who will collect, prepare and administer the product, and which professional license applies to each task. Verify the administering clinician’s current license and relevant specialty with the appropriate state medical, nursing or other professional board. The correct board and rules vary by state, so obtain the jurisdiction’s information directly rather than relying on a clinic badge or online testimonial.
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Clarify whether the clinic itself performs processing or sends material to another laboratory. Ask for the laboratory’s name, location, quality controls and responsibility for errors. You should know who is legally and medically responsible for the product at every stage.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Put the entire financial commitment in writing
FDA materials do not set standard prices or contract terms. Treat the financial agreement as a separate due-diligence document and request an itemized estimate before paying.
- Product, collection, processing and administration fees.
- Imaging, laboratory tests, anesthesia, facility and specialist fees.
- Travel, lodging and required screening visits.
- Follow-up appointments, monitoring and emergency care.
- Repeat or “booster” procedures and their separate prices.
- Cancellation deadlines, refund rules and what happens if you are found ineligible.
- What insurance does and does not cover, and whether payment is required before consent or screening.
Do not let a deposit deadline replace review of the consent form or independent medical advice. A high price does not demonstrate effectiveness, and a discount does not make an unapproved product lawful.
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Compare offers using the same decision criteria
If you are considering more than one clinic, compare written information rather than sales claims. Use the exact product and intended use as the unit of comparison.
| Comparison point | Questions to answer for every offer |
|---|---|
| Product and use | What is it, where does it come from, and what exact condition, dose and route are proposed? |
| Regulatory status | Is it FDA-approved for this use, investigational under an identified trial, or neither? |
| Evidence | Do human studies of the same product and procedure show a meaningful benefit for this condition? |
| Trial documentation | Are the sponsor, investigator, IND number, FDA acknowledgment and consent form available? |
| Safety plan | What testing, monitoring, emergency coverage and complication follow-up are provided? |
| Alternatives | What established care could be delayed or lost, and has the patient’s clinician reviewed that risk? |
| Qualifications | Who administers the treatment, and can the current license and specialty be verified? |
| Total cost | What is included now, what may recur, and what are the cancellation and refund terms? |
Warning signs that justify stopping the process
- The clinic will not name the product, source, dose or exact intended use.
- Staff substitute “FDA registered,” “FDA compliant” or a registry entry for an approval document.
- You are charged for an alleged investigational treatment but cannot review the consent form or trial identity before payment.
- The salesperson promises a cure, universal results or no meaningful risk.
- The clinic discourages contact with your regular clinician or pressures you to stop established treatment.
- There is no written plan for complications, follow-up, records or refunds.
- You are asked to pay immediately because a special price or appointment is expiring.
Any one warning sign warrants a pause and independent verification. Several together are a strong reason not to pay until the clinic answers in writing.
If you experience harm, seek care and report it
Worsening symptoms, severe pain, vision changes, fever, neurological symptoms, breathing problems or other urgent concerns require medical attention; reporting to FDA does not replace treatment. FDA encourages patients and healthcare professionals to report adverse events from products marketed as regenerative medicine through MedWatch.
When reporting, record the product name or type, what happened and when it began, the provider, and the clinic’s name and location. Keep invoices, consent forms, lot or batch details, discharge instructions, photographs and medical records. Tell your treating clinician about the product so the event can be evaluated and documented.
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Proceed only when you can state, in your own words, what the product is, what exact use is proposed, whether FDA has approved that use or the treatment is part of a documented investigation, what remains unknown, how complications will be handled, what established alternatives exist and what the complete financial obligation is. If any of those answers depends on a slogan, an unverifiable registry entry or a promise that documents will arrive after payment, do not pay yet.
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