Well E8 Before and after treatment
What Informed Consent Looks Like in Regenerative Medicine
Contents: 7 sections
A consent form for a stem cell or other regenerative procedure should tell you, in writing, what will be injected and whether the FDA has approved it for your condition, the risks of both the harvest and the injection, what the evidence shows, your alternatives, the full price and refund terms, and any financial stake the doctor or clinic has. A signature on a form is not the same as being informed.
What does informed consent require?
The American Medical Association’s ethics code says the doctor should explain “the diagnosis (when known)”, “the nature and purpose of recommended interventions”, and “the burdens, risks, and expected benefits of all options, including forgoing treatment” (AMA Code of Medical Ethics, Opinion 2.1.1). A clinical reference adds reasonable alternatives with their own risks and benefits, and a check that you understood (StatPearls, Informed Consent).
How much a doctor must disclose is set state by state. Some states ask what a reasonable patient would need to know, others what a typical clinician would say, and StatPearls notes that “many states use the reasonable patient standard” (StatPearls, above). Tennessee ties it to professional practice: in a lawsuit, the patient must show that the information given fell short of “the recognized standard of acceptable professional practice in the profession and in the specialty, if any, that the defendant practices in the community in which the defendant practices and in similar communities” (Tenn. Code § 29-26-118). That is a rule for lawsuits, not a checklist, so ask for what you need to know whether or not the law requires the clinic to say it.
Consent does not always have to be written. The University of Washington’s bioethics department puts it this way: “For a wide range of decisions, explicit written consent is neither required nor needed, but some meaningful discussion is always needed,” and signed forms are “the culmination of a dialogue” (UW Bioethics & Humanities). For an elective procedure you pay for yourself, ask for the form in writing anyway. It is your record of what you were told.
What should the form say before you sign it?
| Line on the form | What it should say | Why it matters |
|---|---|---|
| FDA status | Whether the product is FDA-approved for your condition, and if not, that plainly | The FDA's list of approved cell products includes no stem cell product for joint, spine, tendon or sports injuries (FDA approved products list). "Registered with the FDA" is not approval (FDA). How the rules work is on the page about which stem cell products the FDA has approved |
| What is injected | The source (your bone marrow, your fat, donor tissue), how it is processed and where, and what report you will get about it | Without this you cannot know what you agreed to. What a cell report can and cannot show is on the page about asking for a cell count before the injection |
| Risks of each step | The harvest (for a bone marrow draw, Mayo Clinic lists bleeding, infection and lasting discomfort), the injection (including joint infection), and any risks specific to the spine or disc | Fat harvest risks and the full list are in the stem cell overview; signs that need a call after the procedure are on the recovery page |
| What the evidence shows | Results for your condition, with numbers, or a plain statement that it has not been well studied | For knee arthritis, a Cochrane review found an improvement of 1.2 points on a 10-point pain scale compared with placebo at three to six months, on low-certainty evidence, and was "uncertain of the potential harms" (Cochrane review). The American College of Rheumatology guideline recommends against stem cell and PRP injections for knee and hip arthritis (ACR) |
| Alternatives | Other treatments, including doing nothing, with their own risks and benefits | The AMA wording includes "forgoing treatment" (above) |
| Complications | Whom to call, at any hour, and who pays if something goes wrong | The International Society for Stem Cell Research tells patients to ask "Who will pay for medical expenses if there is an adverse medical event?" (ISSCR) |
| Price and refunds | The total price, what it includes, what a repeat injection costs, and what is refunded if the procedure is cancelled or the harvest does not yield a usable sample | Cost is part of your decision, not an afterthought. Insurance questions are covered on the page about what to ask your insurer before you pay |
| Financial interests | Whether the doctor or clinic owns a stake in the lab, product or device used | For referrals to a facility or product a doctor has a stake in, the AMA code says the doctor should "disclose their financial interest in the facility, product, or equipment to patients" and tell you about alternatives (AMA Opinion 9.6.9) |
Sources for the table: FDA approved products list; FDA; Mayo Clinic; Mayo Clinic; <a href="https://www.cochrane.org/evidence/CD013342what-are-benefits-and-risks-stem-cell-injections-knee-osteoarthritis”>Cochrane review; ACR; <a href="https://static1.squarespace.com/static/611faaa8fee682525ee16489/t/65f09b1918aebc21ebd37efe/1710267161381/ISSCRPatientHandbookv12Feb2024Redesignv4b.pdf”>ISSCR; AMA Opinion 9.6.9.
Related pages: which stem cell products the FDA has approved; asking for a cell count before the injection; stem cell overview; recovery page; what to ask your insurer before you pay.
If a line is missing, ask for it to be added in writing before the procedure day, not in the procedure room. A consultation question list helps you get the same answers out loud.
Is this treatment, or research?
Some clinics describe a paid procedure as part of a “study” or “registry”. A research consent form is a different document, and federal rules say what it must contain. Under FDA regulations, it must include “a statement that the study involves research” and “identification of any procedures which are experimental,” explain whom to contact “in the event of a research-related injury,” and state that you “may discontinue participation at any time without penalty” (21 CFR 50.25).
| Research consent form | Treatment consent form |
|---|---|
| Says the study involves research and names the experimental procedures | Describes a treatment you are choosing |
| Names an ethics committee that approved it. ISSCR: "The providers have approval from an independent committee, such as an Institutional Review Board (IRB)" (ISSCR, above) | No ethics committee involved |
| For a covered trial, says a description of the trial will be available on ClinicalTrials.gov (21 CFR 50.25, above) | No trial number |
| Lists any added costs to you. ISSCR: "It is not customary to pay to be in a clinical trial (other than perhaps travel and other personal expenses)" (ISSCR, above) | You pay the full price |
A “study” that charges thousands of dollars to take part, has no ethics committee named on the form, or has no trial number you can look up does not match the left column. And a ClinicalTrials.gov listing on its own “does not mean the product is legally marketed” (FDA, above).
Which signs in the consent process should make you stop?
- You are handed the form for the first time on the procedure day, or told to sign quickly.
- The form or the staff promise a result: a percentage of pain relief, a return-to-sport date, new cartilage.
- The form does not name the product, where it comes from or how it is processed.
- The form asks you to give up your right to sue or to take any dispute to private arbitration. Have a lawyer read that clause before you sign; we cannot tell you whether it would hold up in your state.
- You are told to stop a prescribed medicine, such as aspirin for your heart or a blood thinner, without the doctor who prescribes it. That decision belongs to the prescriber.
- The clinic says the offer ends today. Pressure is one of several signs of a clinic to walk away from.
Your rights before and after you sign
You can change your mind. StatPearls states that “the patient can refuse or withdraw consent at any time during treatment” (StatPearls, above).
You can take your records to another doctor. Under federal privacy rules you have the right “to inspect, review, and receive a copy of your medical records and billing records,” and “a provider cannot deny you a copy of your records because you have not paid for the services you have received” (HHS). The provider may charge reasonable copying and mailing costs (HHS, above).
Ask for a copy of the form you signed, and keep it with your own notes of what you were told.
Is a complete form enough?
A complete, well-written form tells you that the clinic took the time to inform you. It does not make the treatment work, and it does not make an unapproved product legal. Consent rules also differ from state to state, and nothing on this page is legal advice about a specific form. The rest of the decision is covered in our framework for judging a clinic.
Should you sign?
Not until the form states the FDA status, the risks of each step, the evidence for your condition and the full price, and you have had time to read it at home. A clinic’s willingness to put those things in writing before the procedure is a fair guide to how it would handle a problem afterward.
This page is general information, not medical or legal advice.
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