By Alvin Philipose, DC (Ret.), Clinic Director · Part of our guide to Stem Cells & Exosomes in Oklahoma
Patients with chronic illness are some of the most targeted consumers in health care. Before you pay for any stem cell or exosome procedure, in Oklahoma or abroad, ask these questions and expect clear, written answers.
12 questions to ask
- Is this product FDA-approved for my condition? If not, under what pathway is it being given?
- If it’s investigational, what is the IND number or ClinicalTrials.gov number?
- Is there an IRB overseeing this, and can I contact it?
- What exactly is in the product: cell type, tissue source, cell or particle count?
- Who manufactured it, where, and can I see the certificate of analysis for my lot?
- What sterility, endotoxin and infectious-disease testing was done?
- Who will administer it, and what is their license?
- Which physician oversees the procedure?
- What published evidence exists for my specific condition, and what were the results?
- What are the known risks, and what happens if I have a reaction?
- What will this cost in total, and what is the refund policy?
- Will my outcome be tracked, and will I get copies of my records?
Red flags
- One product claimed to help a long list of unrelated diseases.
- “FDA-registered” or “FDA-compliant lab” presented as if it meant FDA-approved.
- Pressure to pay or book quickly, or “today only” pricing.
- Claims of “millions of live stem cells” with no independent verification.
- Patient testimonials offered in place of published evidence.
- Patients charged to take part in a “study.”
- No written informed consent describing the product’s regulatory status.
- No plan for follow-up or adverse-event reporting.
Green flags
- The clinic states the regulatory status of each product in writing.
- It can point you to registered trials or explain expanded access and Right to Try honestly, including when you don’t qualify.
- There is clear, accountable physician oversight.
- It tells you when an approved treatment should come first.
Report a problem
Adverse reactions to a cell or tissue product can be reported to the FDA through MedWatch at fda.gov/medwatch or by calling 1-800-FDA-1088.
Talk it through with us
If you’re considering a stem cell or exosome option, we’re glad to walk through what you’ve been offered and what lawful pathways exist. Read Legal Pathways to Investigational Treatment or call (405) 848-7246 for a free 15-minute discovery call.
Educational information only, not medical or legal advice. Adapted in part from FDA consumer guidance on stem cell products and ISSCR patient resources.