Localized In Vivo Electro Gene Therapy (<i>LiveGT</i>)-Mediated Skeletal Muscle Protein Factory Reprogramming

Gene electrotransfer (GET) has gained significant momentum as a non-viral gene delivery method for various clinical applications, primarily in the cancer immunotherapy and vaccine development space. Preclinical studies have demonstrated exogenous gene delivery and expression in various tissues, incl...

Full description

Saved in:
Bibliographic Details
Main Authors: Jacob Hensley, Michael Francis, Alex Otten, Nadezhda Korostyleva, Tina Gagliardo, Anna Bulysheva
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Applied Sciences
Subjects:
Online Access:https://www.mdpi.com/2076-3417/14/23/11298
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850061370766131200
author Jacob Hensley
Michael Francis
Alex Otten
Nadezhda Korostyleva
Tina Gagliardo
Anna Bulysheva
author_facet Jacob Hensley
Michael Francis
Alex Otten
Nadezhda Korostyleva
Tina Gagliardo
Anna Bulysheva
author_sort Jacob Hensley
collection DOAJ
description Gene electrotransfer (GET) has gained significant momentum as a non-viral gene delivery method for various clinical applications, primarily in the cancer immunotherapy and vaccine development space. Preclinical studies have demonstrated exogenous gene delivery and expression in various tissues, including the liver, skin, cardiac muscle, and skeletal muscle. However, protein replacement applications of this technology have yet to be fully actuated. Plasmid DNA skeletal muscle delivery has been shown to maintain expression for up to 18 months. In the current study, we evaluated localized skeletal muscle delivery for protein replacement applications. We developed localized in vivo electro gene therapy (<i>liveGT</i>) protocols utilizing mono- and biphasic pulse sequences for localized pulse delivery directly to skeletal muscle with a custom monopolar platinum electrode. Plasmid DNA encoding human insulin and human glucokinase were chosen for this study to evaluate the <i>liveGT</i> platform for protein replacement potential. Initial in vitro GET was performed in mouse myoblasts to evaluate human insulin and glucokinase co-delivery. This was followed by <i>liveGT</i>-mediated reporter gene delivery in the skeletal muscle of Sprague–Dawley rats for pulse sequence selection. Protein replacement potential was evaluated in healthy (non-diabetic) rats with <i>liveGT</i>-mediated human insulin and glucokinase co-delivery to skeletal muscle. Human and rat insulin levels were measured via ELISA over the course of 3 months. Fed-state blood glucose measurements were monitored in correlation with serum human insulin levels. <i>LiveGT</i>-mediated skeletal muscle reprogramming successfully produced physiological levels of human insulin in serum over the course of 3 months. Hypo- and hyperglycemic events were not observed. Therefore, <i>liveGT</i> is a safe and viable platform for potential protein replacement therapies.
format Article
id doaj-art-b2a951ab28424a07b0d54421bcd7bae6
institution DOAJ
issn 2076-3417
language English
publishDate 2024-12-01
publisher MDPI AG
record_format Article
series Applied Sciences
spelling doaj-art-b2a951ab28424a07b0d54421bcd7bae62025-08-20T02:50:16ZengMDPI AGApplied Sciences2076-34172024-12-0114231129810.3390/app142311298Localized In Vivo Electro Gene Therapy (<i>LiveGT</i>)-Mediated Skeletal Muscle Protein Factory ReprogrammingJacob Hensley0Michael Francis1Alex Otten2Nadezhda Korostyleva3Tina Gagliardo4Anna Bulysheva5Department of Medical Engineering, University of South Florida, Tampa, FL 33620, USAAsante Bio, Tampa, FL 33612, USADepartment of Medical Engineering, University of South Florida, Tampa, FL 33620, USADepartment of Medical Engineering, University of South Florida, Tampa, FL 33620, USADepartment of Medical Engineering, University of South Florida, Tampa, FL 33620, USADepartment of Medical Engineering, University of South Florida, Tampa, FL 33620, USAGene electrotransfer (GET) has gained significant momentum as a non-viral gene delivery method for various clinical applications, primarily in the cancer immunotherapy and vaccine development space. Preclinical studies have demonstrated exogenous gene delivery and expression in various tissues, including the liver, skin, cardiac muscle, and skeletal muscle. However, protein replacement applications of this technology have yet to be fully actuated. Plasmid DNA skeletal muscle delivery has been shown to maintain expression for up to 18 months. In the current study, we evaluated localized skeletal muscle delivery for protein replacement applications. We developed localized in vivo electro gene therapy (<i>liveGT</i>) protocols utilizing mono- and biphasic pulse sequences for localized pulse delivery directly to skeletal muscle with a custom monopolar platinum electrode. Plasmid DNA encoding human insulin and human glucokinase were chosen for this study to evaluate the <i>liveGT</i> platform for protein replacement potential. Initial in vitro GET was performed in mouse myoblasts to evaluate human insulin and glucokinase co-delivery. This was followed by <i>liveGT</i>-mediated reporter gene delivery in the skeletal muscle of Sprague–Dawley rats for pulse sequence selection. Protein replacement potential was evaluated in healthy (non-diabetic) rats with <i>liveGT</i>-mediated human insulin and glucokinase co-delivery to skeletal muscle. Human and rat insulin levels were measured via ELISA over the course of 3 months. Fed-state blood glucose measurements were monitored in correlation with serum human insulin levels. <i>LiveGT</i>-mediated skeletal muscle reprogramming successfully produced physiological levels of human insulin in serum over the course of 3 months. Hypo- and hyperglycemic events were not observed. Therefore, <i>liveGT</i> is a safe and viable platform for potential protein replacement therapies.https://www.mdpi.com/2076-3417/14/23/11298insulingene electrotransfer<i>liveGT</i>gene therapyglucoseprotein replacement therapy
spellingShingle Jacob Hensley
Michael Francis
Alex Otten
Nadezhda Korostyleva
Tina Gagliardo
Anna Bulysheva
Localized In Vivo Electro Gene Therapy (<i>LiveGT</i>)-Mediated Skeletal Muscle Protein Factory Reprogramming
Applied Sciences
insulin
gene electrotransfer
<i>liveGT</i>
gene therapy
glucose
protein replacement therapy
title Localized In Vivo Electro Gene Therapy (<i>LiveGT</i>)-Mediated Skeletal Muscle Protein Factory Reprogramming
title_full Localized In Vivo Electro Gene Therapy (<i>LiveGT</i>)-Mediated Skeletal Muscle Protein Factory Reprogramming
title_fullStr Localized In Vivo Electro Gene Therapy (<i>LiveGT</i>)-Mediated Skeletal Muscle Protein Factory Reprogramming
title_full_unstemmed Localized In Vivo Electro Gene Therapy (<i>LiveGT</i>)-Mediated Skeletal Muscle Protein Factory Reprogramming
title_short Localized In Vivo Electro Gene Therapy (<i>LiveGT</i>)-Mediated Skeletal Muscle Protein Factory Reprogramming
title_sort localized in vivo electro gene therapy i livegt i mediated skeletal muscle protein factory reprogramming
topic insulin
gene electrotransfer
<i>liveGT</i>
gene therapy
glucose
protein replacement therapy
url https://www.mdpi.com/2076-3417/14/23/11298
work_keys_str_mv AT jacobhensley localizedinvivoelectrogenetherapyilivegtimediatedskeletalmuscleproteinfactoryreprogramming
AT michaelfrancis localizedinvivoelectrogenetherapyilivegtimediatedskeletalmuscleproteinfactoryreprogramming
AT alexotten localizedinvivoelectrogenetherapyilivegtimediatedskeletalmuscleproteinfactoryreprogramming
AT nadezhdakorostyleva localizedinvivoelectrogenetherapyilivegtimediatedskeletalmuscleproteinfactoryreprogramming
AT tinagagliardo localizedinvivoelectrogenetherapyilivegtimediatedskeletalmuscleproteinfactoryreprogramming
AT annabulysheva localizedinvivoelectrogenetherapyilivegtimediatedskeletalmuscleproteinfactoryreprogramming