Questions to Ask a Regenerative Medicine Clinic, and What a Complete Answer Contains
- Document links
- 9
- Fact-checked
- 18 September 2026
- Reviewed
- every twelve months
Sources on this page: www.fda.gov · clinicaltrials.gov · www.ftc.gov · download.cms.gov
Questions to Ask a Regenerative Medicine Clinic, and What a Complete Answer Contains
This is not a test of the person across the desk. It is a recording tool.
The purpose is to leave the appointment with answers you can compare later against a document, against a public list, or against a second opinion. Spoken answers are hard to compare. Written ones are not.
Below are twelve questions. Each comes with a line on why it is being asked, and a description of what a complete answer contains. For most of them that description names three things, and the third is included because an answer can cover two of the three and still leave you without what you came for. Complete is not the same as favourable. A complete answer can tell you that something is not approved, and that is still a complete answer.
How to use this list
Print it. Choose three or four rather than all twelve. Leave room to write.
The questions are grouped so that a short visit can cover one group properly rather than all six badly. If you only have time for one group, the product group is where the other answers hang from.
About the product
1. What exactly will be administered, under what product or preparation name, and where does the material come from?
Why: two different names are needed here and they do different jobs. The product or preparation name is the key that public records are indexed by, so without it no regulatory lookup can run at all. The material is what tells you which framework to check once a lookup returns nothing. The questions about approval, criteria, evidence and risk all depend on one or both.
A complete answer contains: the exact product, preparation or trade name as it is written down; the name of the material; its source tissue; whether it comes from you or from a donor; and who prepares or manufactures it, where that is a separate party. If the answer gives you a material description and no product name, ask again in writing for the name; that is the one item nothing else on this list can replace.
2. Is this product FDA approved for the indication you are proposing? If not, what is its regulatory status?
Why: approval attaches to a product and a specific licensed use, not to a facility or a field.
A complete answer contains: three things. A yes or no about the specific proposed use rather than the product in general; if no, a statement of which category it falls into, rather than a change of subject to registration or regulation; and the name or number you would search to check it yourself.
3. First: is what you are proposing an HCT/P at all? If it is, does this product meet the four criteria in 21 CFR 1271.10(a); if it does not, do this procedure and this establishment fall within an exception in 1271.15; and if neither, what premarket pathway did the product go through?
Why: this question has a finite set of answers, so it is hard to answer without saying something specific. It starts with the HCT/P question because not everything offered in this field is an HCT/P, and the four criteria only decide the position of products that are. Asked without that opening clause, the question presumes a category and can get a confidently wrong answer about something regulated by a different route, a device-cleared preparation system for example.
A complete answer contains: three things. Which of the three branches applies, named rather than implied; what makes it that branch, meaning which criterion, which exception, or which pathway; and whatever records that basis, which may be a document, and which is an FDA application, authorization, clearance or registration number only where one applies to that branch. Not every branch produces a number: a product regulated solely under section 361 has no approval or clearance number to give, and a registration or listing, where one exists, records that a party notified FDA rather than that FDA agreed with the classification. A general statement that everything is compliant answers none of the three.
About the evidence
4. Is this a registered study? If so, which registry, and what is the identifier?
Why: a registry number is checkable in a way that a description is not. Ask which registry as well as the number, because there is more than one and an identifier is only findable in the register that issued it. An NCT number belongs to ClinicalTrials.gov; a number in another format belongs somewhere else and you will want to know where.
A complete answer contains: three things. The registry name; the identifier in that registry; and whether you are being charged, because a registered study and a paid procedure are separate facts and both can be true. Or, instead of all three, a clear statement that this is not a registered study.
5. What published evidence exists for this product in this use?
Why: evidence for one use does not transfer to another, and this is where that becomes visible.
A complete answer contains: three things. Specific references you can retrieve rather than a description of a literature; the indication and population each one studied, so you can see whether it matches what is proposed; and whether the work was in people, which is the fastest thing to establish and the easiest to skip over.
About who does it
6. Who will perform the procedure, with what specialty training and what license?
Why: the person administering treatment and the person you consulted with may be different people, and licensure is publicly checkable.
A complete answer contains: a name, a specialty, and a license you could verify.
About risk and follow-up
7. What are the known risks and complications, and what is the source of that risk information?
Why: where the risk list comes from matters as much as what is on it. An approved product has labeling; interventional research involving the product has a consent document; other situations have other sources, or none.
A complete answer contains: three things. The risks themselves; the document they are drawn from, whether that is labeling, a consent form or a published list; and whether that document is about this product or about a category it belongs to. A verbal list with no document behind it is the answer to a different question.
8. How will follow-up work, for how long, and who is responsible for it?
Why: complications can appear after the treating relationship has ended, and whoever sees you next will need to know what was administered.
A complete answer contains: a named person or role, a duration, and a statement of what documentation you will receive.
About the money
9. How many sessions are anticipated, and at what intervals?
Why: a per session figure means something different depending on how many sessions are expected.
A complete answer contains: three things. A number or a range; what would change it; and when the decision to continue or stop is taken, and by whom. A single session quoted without the expected course is not an answer to this question.
10. What is the total cost, everything included, and may I have it in writing?
Why: a written total is the only version that can be compared with another written total.
A complete answer contains: three things. A total for the recommended course, not a per-session figure; an itemisation of what is inside it; and an explicit list of what is outside it. Ask for the third one by name, because it is the one that gets left out.
11. What happens if it does not work? Is there a repeat fee, and what does the paperwork say about that?
Why: this provision sits in the document, and the document is where to read it rather than relying on what was said.
A complete answer contains: three things. A reference to the specific term in the paperwork rather than a reassurance; what a repeat would cost, if one is offered; and who decides whether it has worked, and against what measure. The third is the one to ask for explicitly, because an answer can cover the first two and leave it out.
About what you take home
12. May I take the consent document or agreement home to read before signing?
Why: reading an agreement under time pressure in a room full of people is not the same as reading it.
A complete answer contains: three things. A yes, or a clear explanation of why not; the name of the document, so you can tell whether the version you take home is the version you are later asked to sign; and an answer about a copy, which is where the two situations part company.
If what you are signing is a research consent form, a copy is a federal requirement of the research rules and our page on the document you sign quotes the federal source for it. If what you are signing is an ordinary treatment agreement or consent to a procedure, ask whether you may keep a copy and note the answer you get. We have not sourced a federal entitlement to a copy in that second situation and we are not going to imply one; asking is still the right move, and an unwillingness to provide a copy is information either way.
What a complete answer contains
Across all twelve, completeness has the same shape.
A complete answer names the thing rather than describing its category. A product name, a registry number, a license, a document. It states scope: for this use, for this population, under this pathway. It is willing to be written down, and where it refers to a document it says which document.
An incomplete answer restates the question in other words, moves from the product to the practice, or replaces a specific with a reassurance. None of those means anyone is being evasive. They mean you do not yet have the answer, and asking again is reasonable.
Note what this page does not do. It does not tell you that a particular answer is good or bad, and it does not suggest walking away on any specific response. It gives you a record. What that record means for your decision is a matter for you and for a clinician who knows your history.
Where to go from here
Once you have the answers written down, they can be checked. The product name goes to the approved list, the license goes to the public record, the registry number goes to the registry, and the evidence goes to the study checklist.
Before you leave this page: print the list, choose your three or four, and leave the margin wide.
What this does not mean
This page does not rate clinics, does not tell you which answers should end a conversation, and does not offer medical or legal advice. It provides a set of questions and a description of what a complete answer looks like. Whether a treatment is suitable for you is a clinical judgment that belongs with a qualified professional.
Official sources behind these questions. This page quotes nothing directly. Each question is derived from a record examined on another page of this site, and the full dependency list is below rather than a selection from it. Each question here is only as good as the record behind it, and those records are one click away.
The full dependency list, with the question each record sits behind:
- FDA · Important Patient and Consumer Information About Regenerative Medicine Therapies · accessed 18 September 2026 · questions 1 and 7, the material enumeration and the published risk list
- FDA · Approved Cellular and Gene Therapy Products · accessed 18 September 2026 · question 2, the licensed list and the indication to match against
- FDA · Minimal Manipulation and Homologous Use (guidance, July 2020) · accessed 18 September 2026 · question 3, the four criteria
- FDA · Same Surgical Procedure Exception under 21 CFR 1271.15(b) (PDF) · accessed 18 September 2026 · question 3, the exception
- ClinicalTrials.gov · accessed 18 September 2026 · question 4, the registry record and its fields
- FTC · Health Products Compliance Guidance · accessed 18 September 2026 · question 5, what counts as evidence for a claim
- FDA · Step 3: Clinical Research · accessed 18 September 2026 · question 5, what a trial phase is for
- FDA · Protection of Human Subjects; Informed Consent · accessed 18 September 2026 · question 12, the consent requirements, where the document is a research consent
- CMS · NPPES NPI Files · accessed 18 September 2026 · question 6, why an identifier is not a licence
Questions with no record behind them, named rather than hidden. Four of the twelve rest on no external source: question 8 (follow-up responsibility), question 9 (session count), question 10 (total cost) and question 11 (what happens if it does not work). They are there because the paperwork and the invoice are the documents that answer them, and we have opened no document that tells us how any practice handles them. Our pricing page states the same limit about itself.
Written and fact-checked against the sources above on 18 September 2026. No independent expert review has taken place yet, and this page says so rather than implying one. This page is reviewed every twelve months and whenever the FDA approved products list changes.