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CoreCyte is a human cell, tissue, and cellular and tissue-based product (HCT/P) derived from the umbilical cord, developed by Predictive Biotech. It is processed as a minimally manipulated tissue allograft containing components from the umbilical cord, specifically Wharton's Jelly, which is rich in mesenchymal stem cells (MSCs), cytokines, growth factors, and hyaluronic acid. CoreCyte is primarily utilized in regenerative medicine and orthopedic clinical settings to provide structural support, cushioning, and lubrication to damaged or inadequate connective tissues, such as those in joints. While it is marketed under Section 361 of the Public Health Service Act as a structural tissue product, the FDA has issued warnings regarding the marketing of such umbilical cord-derived products as unapproved biologics for systemic or non-homologous therapeutic uses.
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