What Healing Looks Like | TruDOSE Therapy

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This web site is provided for educational and informational purposes about platelet therapy and does not constitute providing medical advice or professional services. All information provided on this website is from physician observational evidence or patient testimonials and not published clinical studies or clinical trials. As such, this information should not be used for diagnosing or treating a health problem or disease. Individuals seeking personal medical advice should consult with a licensed physician. Always seek the advice of your doctor or other qualified health provider regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. No physician-patient relationship is created by this web site or its use.

As of June 1, 2021, the FDA updated their guidance on all “stem cell regenerative” therapies. The FDA makes a clear distinction on the use of autologous (from you) platelet therapies compared to donor cell therapies (cells not from you). The FDA1 states: “This guidance also does not apply to products that fall outside the definition of HCT/P in 21 CFR 1271.3(d). For example, platelet rich plasma (PRP, blood taken from an individual and given back to the same individual as platelet rich plasma) is not an HCT/P under 21 CFR Part 1271 because it is a blood product. Accordingly, FDA does not apply the criteria in 21 CFR 1271.10(a) to PRP, and PRP is outside the scope of this guidance.”

1 https://www.fda.gov/media/109176/download

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