Stem Cell News & Regulation
FDA actions, warning letters, industry accountability, and the regulatory landscape around stem cell and exosome therapy — read against the primary record, not the marketing.
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February 5, 2025
FDA Stem Cell & Exosome Therapy Crackdown: What It Means for Regenerative Medicine
The FDA issued warning letters to Chara Biologics, INCELL, Neobiosis, and Platinum Biologics for cGMP violations and unapproved biologic manufacturing — reframing perinatal-derived products as biologic drugs rather than tissue allografts.
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February 4, 2025
FDA Issues Warning to Chara Biologics Over Unapproved Stem Cell and Exosome Products
The FDA cited Chara Biologics for marketing three unapproved cell and exosome products — CharaExo, CharaCore, and CharaOmni — for conditions including Alzheimer's, Parkinson's, and autism. The agency flagged cGMP failures, misbranding, and unsupported clinical claims.
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January 22, 2025
The Ethics of Stem Cell Therapy
What I had to learn the hard way about cell quality, expansion cycles, injector skill, and the insurance gap that funnels patients toward surgery — written for the patient who's been told regenerative medicine isn't real medicine.