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Intradermal delivery of modified mRNA encoding VEGF-A in patients with type 2 diabetes
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Intradermal delivery of modified mRNA encoding VEGF-A in patients with type 2 diabetes
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Journal Article
Intradermal delivery of modified mRNA encoding VEGF-A in patients with type 2 diabetes
2019
Overview
Chemically modified mRNA is an efficient, biocompatible modality for therapeutic protein expression. We report a first-time-in-human study of this modality, aiming to evaluate safety and potential therapeutic effects. Men with type 2 diabetes mellitus (T2DM) received intradermal injections of modified mRNA encoding vascular endothelial growth factor A (VEGF-A) or buffered saline placebo (ethical obligations precluded use of a non-translatable mRNA control) at randomized sites on the forearm. The only causally treatment-related adverse events were mild injection-site reactions. Skin microdialysis revealed elevated VEGF-A protein levels at mRNA-treated sites versus placebo-treated sites from about 4–24 hours post-administration. Enhancements in basal skin blood flow at 4 hours and 7 days post-administration were detected using laser Doppler fluximetry and imaging. Intradermal VEGF-A mRNA was well tolerated and led to local functional VEGF-A protein expression and transient skin blood flow enhancement in men with T2DM. VEGF-A mRNA may have therapeutic potential for regenerative angiogenesis.
Chemically modified mRNA is a new approach for therapeutic protein expression that could be applied to angiogenesis. Here the authors show in a phase 1 clinical trial that a modified mRNA encoding VEGF-A is well tolerated in patients with type 2 diabetes.
Publisher
Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
Subject
/ 42/44
/ 59
/ Adult
/ Aged
/ Cardiology and Cardiovascular Disease
/ Coding
/ Diabetes
/ Diabetes mellitus (non-insulin dependent)
/ Diabetes Mellitus, Type 2 - therapy
/ foot
/ Forearm
/ Humanities and Social Sciences
/ Humans
/ Kardiologi och kardiovaskulära sjukdomar
/ Male
/ mRNA
/ Neovascularization, Physiologic - physiology
/ Placebos - administration & dosage
/ Proteins
/ Regional Blood Flow - genetics
/ RNA, Messenger - adverse effects
/ RNA, Messenger - therapeutic use
/ Science
/ Science & Technology - Other Topics
/ Skin
/ vaccines
