Washington State Stem Cell & Regenerative Medicine Legalities

Washington is proactive in regulating regenerative treatments. Since 2018, RCW 18.130.420 has required clinics offering non-FDA approved stem cell therapies to provide clear warning signage and obtain patient consent. The state has also taken strong action against deceptive clinics⎼highlighting both promise and risk.

✅ What’s Legal in Washington?

  • Written Warning & Consent Requirement
    Providers offering FDA-unapproved stem cell treatments must display a formal notice (11″×8.5″, 40pt type) in-office and in advertising, and obtain signed consent detailing FDA status, risks, alternatives, and benefits⎼per RCW 18.130.420.

  • Autologous Stem Cell & PRP Therapies
    Same-day procedures using your own cells (e.g. bone marrow, fat) and PRP treatments are permitted as part of standard medical practice under FDA minimal manipulation policies.

  • Stem Cell Transplants in Approved Facilities
    Facilities offering stem cell transplants under Medicaid or Medicare must meet AABB, UNOS, and FDA/HCT/P standards—even if not FDA-approved for broader use⎼WAC 182‑550‑2100 .

⚠️ What to Watch Out For

  • Enforcement Actions
    Washington Attorney General shut down US Stemology in 2022 after it falsely claimed its stem cell injections could treat COVID-19 and neurological conditions—resulting in a $500K settlement .

  • Insurance Coverage Denial
    Washington Health Care Authority officially does not cover stem cell therapies for musculoskeletal conditions (since September 2020) due to lack of sufficient evidence.

  • Risky Marketing Tactics
    The state treats false claims about stem cell treatments as unprofessional conduct, subject to legal action and penalties.

Smart Steps Before You Begin

  1. Verify clinic compliance: Ensure they post the RCW 18.130.420 notice and collect consent forms.

  2. Confirm provider credentials: Check if they follow HCT/P and transplantation facility standards.

  3. Research outcomes: Seek published safety or efficacy data.

  4. Speak with a primary doctor: Discuss risks, benefits, and alternatives.

State Regulation Resource

View RCW 18.130.420 for full law text on informed consent and advertising
[Washington Revised Code – Stem Cell Therapies] ⎼ see Section 420 .

⚠️ Important Disclaimer
This guide is for informational purposes only and does not constitute medical or legal advice. Patients should consult with a qualified provider before undergoing any regenerative treatment.

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