Questions to Ask Before a Regenerative-Medicine Procedure Conversation

By the Regenerative Evidence Guide Team

By Regenerative Evidence Guide Editorial Team

Ask about FDA approval status, clinical trial oversight, product source, and known risks before any regenerative-medicine procedure. These four questions reveal whether a treatment is legally offered and what evidence actually supports it — before you agree to anything.

If you are currently having a reaction after a procedure — such as sudden vision changes, worsening pain, fever, or signs of infection at an injection or collection site — treat this as a medical emergency. Contact your local emergency services or go to an emergency room right away instead of researching questions to ask later.

What Should You Ask Before a Regenerative-Medicine Procedure?

Start with product identity and regulatory status, then move to alternatives, risk, provider experience, and follow-up care. Each of these areas has a specific, answerable question attached to it, and a provider offering a legitimate treatment should be able to answer all of them without hesitation.

Before you get to those specific questions, it helps to know a few terms that will come up in the conversation:

• Regenerative medicine product: A broad category that includes stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood or cord blood stem cells, amniotic fluid, Wharton’s jelly, ortho-biologics, and exosomes.
• FDA approval or licensure: The formal review process a product must pass before it can be legally marketed for a specific use.
• IND (Investigational New Drug application): The application a company or clinic must have on file with the FDA to legally test an unapproved regenerative medicine product in people, including safety oversight requirements.
• Clinical trial with FDA oversight: A study conducted under an active IND, where the FDA monitors safety protocols. This is different from simply being listed on a public trial registry.
• Adverse event: Any unwanted or harmful reaction linked to a medical product, which can be formally reported to the FDA.

Is Every Regenerative-Medicine Treatment FDA-Approved?

No. According to the FDA, only one category of stem cell product is currently approved for use in the United States: blood-forming stem cells derived from umbilical cord blood, and only for disorders that affect blood production. Everything else marketed as regenerative medicine falls into a different, unapproved category.

FDA-approved and licensed:

• Blood-forming (hematopoietic) stem cell products derived from umbilical cord blood, approved specifically for blood-production disorders.

Not FDA-approved, and requiring an IND to be legally offered for other conditions:

• Stem cells (including those recovered from your own body)
• Stromal vascular fraction (fat-derived cells)
• Umbilical cord blood or cord blood stem cells used for anything other than approved blood disorders
• Amniotic fluid
• Wharton’s jelly
• Ortho-biologics
• Exosomes

The FDA has specifically stated that regenerative medicine therapies have not been approved to treat COVID-19 or its complications, autism, macular degeneration, blindness, chronic pain, fatigue, neurological disorders such as multiple sclerosis, ALS, Alzheimer’s, Parkinson’s, epilepsy, or stroke, cardiovascular or pulmonary disease, or orthopedic conditions such as osteoarthritis, tendonitis, disc disease, or joint pain. If a clinic is offering an unapproved product for any of these, that’s useful to know before the conversation goes further. Our editorial policy explains how we verify claims like these against primary sources before publishing them.

What Questions Should You Ask Your Provider, Step by Step?

Work through these five steps in order during your appointment. Each step covers a different risk area, so skipping ahead can mean missing something important.

Step 1: Ask About Product Identity and Regulatory Status

• What exactly is this product, and where does the material come from?
• Is this product FDA-approved or licensed for the condition you’re treating in me?
• If it isn’t approved, is it being provided to me under an active FDA Investigational New Drug application?
• Is this product just listed on a public trial registry, or is it actually part of a trial with FDA safety oversight? These are not the same thing.

Step 2: Ask Why This Procedure and What Else Exists

• Why do you think this treatment is right for my situation?
• Are there any approved alternatives for this condition?
• What happens if I choose to wait or do nothing?

Step 3: Ask About Risk and What Could Go Wrong

• What are the possible complications or side effects specific to this product?
• Could this affect other medicines I’m taking, or interact with an existing condition?
• How is the product tested for contamination, and how is sterility handled during preparation?

Step 4: Ask About Experience and Track Record

• How many times have you personally performed this specific procedure?
• Who prepares the product, and where is that done?

Step 5: Ask What Happens After

• How and when will I know if the treatment worked?
• What follow-up monitoring is included, and for how long?
• Who do I contact if something feels wrong after the procedure?

What Are the Red Flags of an Unapproved Regenerative-Medicine Offer?

Three patterns show up repeatedly in FDA warnings about unapproved regenerative-medicine marketing, and any one of them is worth pausing on.

• Being charged for a product outside of an FDA-overseen clinical trial. The FDA states that if you’re being charged for, or offered, one of these products outside such a trial, you may be being offered a product illegally.
• Being pointed to a trial registry as proof of legitimacy. The FDA has noted that patients are sometimes told a product’s presence on clinicaltrials.gov, or a company’s registration with the FDA, means the product is legally marketed. The FDA says this is often false — registry listing or registration alone does not mean a product is approved or legally sold.
• Claims that one treatment addresses a long list of unrelated conditions. A single unapproved product being promoted for many different diseases is a pattern the FDA has flagged directly.

What Should You Do If You Already Received an Unapproved Product?

If you were treated with a regenerative medicine product and had a bad reaction, or you have concerns about a product you’re currently being offered, the FDA has specific channels for this:

• You can report side effects or complications through the FDA’s MedWatch Adverse Event Reporting program.
• You can contact the FDA directly with questions about a product you’re considering or have already received, or to file a complaint, at ocod@fda.hhs.gov.

Reporting an adverse event doesn’t require you to have all the answers first. It gives the FDA information it uses to track patterns across clinics and products.

Common Questions About Regenerative-Medicine Procedure Conversations

Does being listed on ClinicalTrials.gov mean a treatment is FDA-approved?

No. The FDA has specifically warned that a listing on ClinicalTrials.gov, or a company’s registration with the FDA, does not mean a product is legally marketed or approved. Ask directly whether the treatment has an active FDA Investigational New Drug application, not just whether it’s listed anywhere.

Can a clinic legally charge me for an unapproved regenerative-medicine product?

Generally, no, unless it’s part of a clinical trial with active FDA oversight. The FDA states that being charged for one of these products outside such a trial may mean you’re being offered it illegally.

What’s the difference between stem cells from my own body and an approved stem cell product?

Only one stem cell category is FDA-approved: blood-forming stem cells from umbilical cord blood, used for blood-production disorders. Stem cells recovered from your own body for other conditions fall into the unapproved category and require an active IND to be offered legally.

Who do I contact if I think I was harmed by a regenerative-medicine treatment?

You can report the reaction through the FDA’s MedWatch Adverse Event Reporting program, or contact the FDA directly at ocod@fda.hhs.gov with questions or complaints about a specific product or clinic.

Where Can You Learn More Before Your Appointment?

This checklist is meant to prepare you for a conversation with a licensed healthcare provider, not to replace one. If you’re new to evaluating regenerative-medicine claims generally, our Start Here page walks through how to read evidence quality before you get to the procedure-question stage. To see how we select and verify the sources behind guides like this one, visit How We Research.

This article is for general educational purposes and is not medical advice, a treatment recommendation, or a substitute for care from a licensed healthcare provider. Only a qualified clinician who knows your medical history can advise you on a specific procedure. See our medical information disclaimer for more detail. If you are experiencing a medical emergency, contact your local emergency services immediately.