drugset / Trial / NCT02359825

Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

NCT02359825

Phase 1 Completed 45 enrolled Vanderbilt University Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

Current strategies for peripheral nerve repair are severely limited. Even with current techniques, it can take months for regenerating axons to reach denervated target tissues when injuries are proximally located. This inability to rapidly restore the loss of function after axonal injury continues to produce poor clinical outcomes. The investigators propose testing the efficacy and safety of a combination therapy: polyethylene glycol (PEG) assisted axonal fusion technique to repair peripheral nerve injuries in humans.

Timeline

Start
2019-09-19
Primary completion
2026-05-21
Completion
2026-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject polyethylene glycol Other / unclassified 50 % Other