CTE Biologics, Inc.
Investigational New Drug Application #27377 titled as: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy Patients.
Chronic traumatic encephalopathy (CTE) is the term used to describe brain degeneration likely caused by repeated head traumas. Although formal diagnosis is made after death, criteria have been developed which tightly correlate with post-mortem findings. Based on behavioral and laboratory abnormalities, we propose a clinical trial in patients with advanced symptoms of CTE, as identified based on multiple concussions, behavioral markers and biomarkers.
Major components to neurodegeneration associated with CTE include hyperproduction of inflammatory cytokines, reduction in T regulatory cells, and augmented oxidative stress.
Mesenchymal stem cells (MSC) have been reported by numerous groups as possessing anti-inflammatory and neuroregenerative activity. The CTEcell is a newly discovered MSC originating from the umbilical cord, which has demonstrated potent anti-inflammatory activity in vitro and in vivo.
The current study will assess primary safety and secondary efficacy endpoints for treatment of 10 patients with advanced CTE using a total dose of 200 million CTEcells intravenously. Patients will be assessed at 1, 3, and 6 months for behavioral improvement, reduction in inflammatory cytokines, and changes on brain imaging.
This study will provide proof of concept for expanded studies using regenerative approaches to this significant unmet medical need.