ArticleCase reports in dentistry2016
World's First Clinical Case of Gene-Activated Bone Substitute Application.
Article in Case reports in dentistry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02293031 (Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration), which is not on this map. Cited by 17 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration
Who cites it
17 citing papers in PubMed, 37 citations in OpenAlex.
- Fracture healing: from molecular and cellular mechanisms to therapeutic strategies.Signal transduction and targeted therapy · 2026Review
- Biologics for bone regeneration: advances in cell, protein, gene, and mRNA therapies.Bone research · 2026Review
- Multifunctional DNA-Collagen Biomaterials: Developmental Advances and Biomedical Applications.ACS biomaterials science & engineering · 2025Review
- Functional Scaffolds for Bone Tissue Regeneration: A Comprehensive Review of Materials, Methods, and Future Directions.Journal of functional biomaterials · 2024Review
- Gene Therapeutic Drug pCMV-VEGF165 Plasmid ('Neovasculgen') Promotes Gingiva Soft Tissue Augmentation in Rabbits.International journal of molecular sciences · 2024Article
- Gene-Activated Materials in Regenerative Dentistry: Narrative Review of Technology and Study Results.International journal of molecular sciences · 2023Review
- Delivery of Growth Factors to Enhance Bone Repair.Bioengineering (Basel, Switzerland) · 2023Review
- Scaffold Guided Bone Regeneration for the Treatment of Large Segmental Defects in Long Bones.Biomedicines · 2023Review
- Gene therapy for bone healing: lessons learned and new approaches.Translational research : the journal of laboratory and clinical medicine · 2021Review
- Orthopaedic Gene Therapy: Twenty-Five Years On.JBJS reviews · 2021Article
- Systematic Review of the Preclinical Technology Readiness of Orthopedic Gene Therapy and Outlook for Clinical Translation.Frontiers in bioengineering and biotechnology · 2021Review
- Clinical Application of Bone Marrow Mesenchymal Stem/Stromal Cells to Repair Skeletal Tissue.International journal of molecular sciences · 2020Review
- Review
- 3D Printed Gene-activated Octacalcium Phosphate Implants for Large Bone Defects Engineering.International journal of bioprinting · 2020Article
- The Few Who Made It: Commercially and Clinically Successful Innovative Bone Grafts.Frontiers in bioengineering and biotechnology · 2020Review
- Current Trends in Viral Gene Therapy for Human Orthopaedic Regenerative Medicine.Tissue engineering and regenerative medicine · 2019Review
- Comment on "World's First Clinical Case of Gene-Activated Bone Substitute Application".Case reports in dentistry · 2017Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Treatment of patients with large bone defects is a complex clinical problem. We have initiated the first clinical study of a gene-activated bone substitute composed of the collagen-hydroxyapatite scaffold and plasmid DNA encoding vascular endothelial growth factor. The first patient with two nonunions of previously reconstructed mandible was enrolled into the study. Scar tissues were excised; bone defects (5-14 mm) between the mandibular fragments and nonvascularized rib-bone autograft were filled in with the gene-activated bone substitute. No adverse events were observed during 12 months of follow-up. In 3 months, the average density of newly formed tissues within the implantation zone was 402.21 ± 84.40 and 447.68 ± 106.75 HU in the frontal and distal regions, respectively, which correlated with the density of spongy bone. Complete distal bone defect repair with vestibular and lingual cortical plates formation was observed in 6 and 12 months after surgery; thereby the posterior nonunion was successfully eliminated. However, there was partial resorption of the proximal edge of the autograft entailed to relapse of the anterior nonunion. Thus, the first clinical data on the safety and efficacy of the gene-activated bone substitute were obtained. Given a high complexity of the clinical situation the treatment, results might be considered as promising. NCT02293031.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.