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Central to the pathophysiology of many neurological disorders are disruptions in the blood-brain barrier (BBB) and blood-spinal cord barrier (BSCB), both of which serve as crucial protective interfaces regulating the exchange between the bloodstream and the central nervous system (CNS)

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The total human evidence base, as of this writing, consists of the following: 1) a Phase I safety trial of 42 healthy volunteers that was registered in 2015, canceled in 2016, and never published, 2) a retrospective case series of 12 patients with knee pain, no control group, and no validated outcome measure, and 3) a 2025 pilot safety study involving two healthy adults who received intravenous infusions at a single private clinic in Florida