Several exosome and cell products for wound healing have received FDA approval or clearance in recent years (e.g., for registered clinical trials). Some products have obtained CE marking in the EU under IVDR or ATMP frameworks, though the regulatory landscape remains evolving and many products remain investigational.
Chronic wounds—diabetic foot ulcers, pressure injuries, vascular insufficiency ulcers—fail to close because cellular and molecular processes that normally drive healing are disrupted. Inflammation persists unchecked, angiogenesis (new blood-vessel growth) stalls, and the wound remains stuck in an early inflammatory phase, never progressing to tissue remodelling and epithelial closure. Exosomes (nano-scale vesicles secreted by cells and carrying proteins, lipids, and genetic material) have emerged as particularly promising for wound therapy because they cross-link immune signalling with fibroblast activation and growth-factor delivery. Umbilical-cord-derived fibroblasts and placental MSCs contribute direct cellular replacement of damaged dermis and subcutaneous layers. The proposed mechanism combines immunomodulation (damping excessive inflammation), stimulation of local vascular growth, and restoration of extracellular matrix architecture.
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Rivisto medicalmente dal team editoriale di StemCellAtlas con the Stem Plus medical team (physicians & scientists · GMP-certified Sofia laboratory · 25+ yrs international experience) della clinica partner Stem Plus (Sofia), rispetto alle linee guida ISSCR, FDA e EMA. Educational information, not medical advice; figures indicative.
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