Bringing a Gene-Activated Bone Substitute Into Clinical Practice: From Bench to Bedside.
bone substitute
clinical trial
gene-activated matrix
octacalcium phosphate
osteogenesis
plasmid DNA
vascular endothelial growth factor
Journal
Frontiers in bioengineering and biotechnology
ISSN: 2296-4185
Titre abrégé: Front Bioeng Biotechnol
Pays: Switzerland
ID NLM: 101632513
Informations de publication
Date de publication:
2021
2021
Historique:
received:
26
08
2020
accepted:
11
01
2021
entrez:
22
2
2021
pubmed:
23
2
2021
medline:
23
2
2021
Statut:
epublish
Résumé
Bone grafting and reconstruction are still challenging in clinical practice because of the limitations of bone autografts and the drawbacks of currently approved bone substitutes. We thus developed a gene-activated bone substitute based on octacalcium phosphate and naked plasmid DNA carrying the vascular endothelial growth factor gene. This advanced combined therapy medicinal product had no cytotoxic effects
Identifiants
pubmed: 33614609
doi: 10.3389/fbioe.2021.599300
pmc: PMC7889956
doi:
Types de publication
Journal Article
Langues
eng
Pagination
599300Informations de copyright
Copyright © 2021 Bozo, Drobyshev, Redko, Komlev, Isaev and Deev.
Déclaration de conflit d'intérêts
The clinical trial, as part of registering a gene-activated bone substitute for clinical use, was carried out under Russian Ministry of Healthcare regulations. Based on an official report examination performed by an expert government institution, market authorization was granted in 2019. The clinical trial and registration process were funded by Histograft LLC. IB, AI, and RD are co-owners of the company. In addition, IB and RD are Histograft employees who participated in the development of the clinical study design in cooperation with the principal investigator (AD); no CRO companies are required for bone substitute registration in the Russian Federation. IB, AI, and RD were not involved in the clinical data collection, analysis, or official report writing. For manuscript writing, all the results were transferred from a clinical trial official report submitted to the Ministry of Healthcare. Additional follow-up data were collected by AD and NR and were analyzed together with IB and RD. The investigated bone substitute is covered by a patent application “Methods of producing optimized gene-activated materials,” US 20190224379A1, patent applicant - Histograft, LLC; inventors: RD, AI, IB, and VK.
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