Clinical Trial: Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
Brief 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.
Detailed Summary:
Our own preclinical animal studies have been designed to take advantage of PEG. We have used the fusogenic properties of PEG and this has allowed us to demonstrate a rapid and decisive electrophysiological recovery of either crushed or completely severed sciatic nerves in a commonly accepted mammalian model for peripheral nerve injury (Bittner et al JSR 2012).
Recently, we modified previously published mammalian techniques. Our goal was to eliminate laboratory solutions that have not been approved for use in humans and replace them with readily available reagents commonly used in clinical applications. PEG is commercially available in many molecular formulations and our earlier experiments with PEG having a molecular weight of 2 kD. Unfortunately, this molecular weight is not approved by the Food and Drug Administration (FDA) for human usage. In our more recent preclinical studies, we have demonstrated that PEG 3.35 kD, the main ingredient in the commonly used cathartic known as MiraLAX© (MERCK; Whitehouse Station, NJ), actually generates superior fusion over PEG 2KD in a cut nerve model. Thus the clinical trial that forms the basis of this proposal was developed with the FDA approved 3.35 kD PEG and these other two FDA approved solutions.
Additional studies in our complex nerve injury model have also demonstrated that the repair does not have to be performed immediately after nerve injury. Epineural repair with PEG 3.35 kD treatment can be performed up to 24hrs after injury and postoperative CAPs are obtained in all PEG 3.35 kD treated animals (n=3, data not shown). The remarkable finding is that in the 24-hour injury model, PEG significantly improves behavioral outcome measured at 72 hours postoperatively.
Based on the published reports and our own in vivo studies, w
Sponsor: Vanderbilt University
Current Primary Outcome: return of nerve function as measured by (Medical Research Council Classificatoin (MRCC) [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Vanderbilt University Medical Center
Dates:
Date Received: February 4, 2015
Date Started: September 2015
Date Completion: February 2018
Last Updated: May 16, 2017
Last Verified: May 2017
