CytosomesTM are manufactured following cGMP guidelines in an FDA-registered laboratory.
Donor suitability and manufacturing is performed in compliance with Public Health Acts, regulated under 21 CFR 1271 HCT/Ps, subpart D cGTP, and 21 CFR 31 (INDs), 210 & 211 (cGMP), 606 and 610.
Disclaimer: Human Cell, Purified Amniotic Fluid, and Tissue products are not FDA approved or licensed for the prevention, treatment, diagnosis, mitigation and/or cure of any disease or condition, including COVID-19. All statements and opinions provided are for educational and informational purposes only. Individuals interested in natural biologics therapy are urged to review all pertinent information with our physicians and do their own research before choosing to participate in treatments utilizing natural biologics products.