Hard Exit
Explicit cure or outcome guarantees
No responsible practitioner guarantees outcomes from unproven biologics. Any guarantee is legally improper and clinically indefensible.
→ Document the language. Do not pay.
Hard Exit
Full payment required before any documentation
Payment before documentation is a consumer fraud pattern. Legitimate providers share COA, procedure plan, and adverse event protocol before any financial commitment.
→ Request documents first. Non-negotiable.
Fraud Signal
Unnamed or unverifiable manufacturer
If the provider cannot name the manufacturing facility, supply chain verification is impossible regardless of other claims.
→ Ask for GMP certification in writing.
Fraud Signal
Claims of zero risk or "all-natural" safety
Stem cells are living biological agents with documented adverse event profiles. Any claim of zero risk reflects ignorance or dishonesty.
→ Ask for the adverse event protocol.
Supply Chain
No Certificate of Analysis offered
Every GMP-manufactured biologic generates a lot-specific COA. "Patients don't receive COAs" is not standard practice at credible facilities.
→ Request it. If declined, walk away.
Supply Chain
Vague source tissue description
Terms like "placental-derived" without specifying the exact product fraction are designed to sound scientific without being accountable.
→ Ask for the exact product name and lot number.
Evidence
Testimonials as primary evidence
Patient-reported improvement without baseline measurements or control groups cannot establish causation. True even when testimonials are genuine.
→ Ask for peer-reviewed trial citations.
Evidence
Animal studies cited as human evidence
Preclinical animal data has not translated reliably to human stem cell therapy efficacy. Animal studies are not evidence of human benefit.
→ Ask for published Phase 1 or Phase 2 human trial data.
Procedure
IV delivery for orthopedic indications
Intravenous delivery for joint or structural conditions has no credible homing mechanism. A documented evidence mismatch in the peer-reviewed literature.
→ Ask for the published mechanism and evidence base.
Procedure
No image guidance for structural procedures
Intra-articular or spinal procedures without ultrasound or fluoroscopic guidance cannot be confirmed to have delivered product to the target site.
→ Confirm image guidance is included.
Measurement
No baseline measurements proposed
Without pre-treatment baselines, there is no objective way to evaluate whether improvement occurred or whether harm was done.
→ Ask what baseline measurements will be taken before treatment.
Measurement
Success defined as "you'll feel better"
Subjective feeling is not a measurable outcome. A provider who cannot define success using validated instruments is not set up to detect failure.
→ Ask: "What validated scale defines success?"
Pressure
Decision urgency — "limited spots" or "price increases soon"
Urgency pressure is a documented fraud tactic. ISSCR explicitly states that patients should not be rushed or financially incentivized to make treatment decisions.
→ Any urgency pressure is a reason to slow down, not speed up.
Marketing
FDA-demonizing or conspiracy framing
Providers who frame FDA oversight as a conspiracy are using a manipulation tactic documented in peer-reviewed analysis of the unproven stem cell market.
→ Ask: "Is this therapy on the FDA's approved cellular therapy list?"
Travel
No emergency plan for cross-border patients
A provider who hasn't addressed what happens if you have a serious adverse event abroad has not planned for your safety.
→ Get the adverse event plan in writing before travel.
Legal
Non-disparagement clauses in treatment contracts
Documented cases exist of stem cell clinics requiring patients to sign agreements preventing negative reviews. Read every document. Refuse these clauses.
→ Refuse to sign. This is not standard medical practice.