A clinically relevant formulation for direct administration of nerve specific fluorophores to mitigate iatrogenic nerve injury

Connor W. Barth, Vidhi M. Shah, Lei G. Wang, Anas M. Masillati, Adel Al-Fatease, Syed Zaki Husain Rizvi, Alexander L. Antaris, Jonathan Sorger, Deepa A. Rao, Adam W.G. Alani, Summer L. Gibbs

Research output: Contribution to journalArticlepeer-review

Abstract

Iatrogenic nerve injury significantly affects surgical outcomes. Although intraoperative neuromonitoring is utilized, nerve identification remains challenging and the success of nerve sparing is strongly correlated with surgeon experience levels. Fluorescence guided surgery (FGS) offers a potential solution for improved nerve sparing by providing direct visualization of nerve tissue intraoperatively. However, novel probes for FGS face a long regulatory pathway to achieve clinical translation. Herein, we report on the development of a clinically-viable, gel-based formulation that enables direct administration of nerve-specific probes for nerve sparing FGS applications, facilitating clinical translation via the exploratory investigational new drug (eIND) guidance. The developed formulation possesses unique gelling characteristics, allowing it to be easily spread as a liquid followed by rapid gelling for subsequent tissue hold. Optimization of the direct administration protocol with our gel-based formulation enabled a total staining time of 1–2 min for compatibility with surgical procedures and successful clinical translation.

Original languageEnglish (US)
Article number121490
JournalBiomaterials
Volume284
DOIs
StatePublished - May 2022
Externally publishedYes

ASJC Scopus subject areas

  • Biophysics
  • Bioengineering
  • Ceramics and Composites
  • Biomaterials
  • Mechanics of Materials

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