Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2013
Phase 1/2 open-label dose-escalation study of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with painful diabetic peripheral neuropathy.
Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01002235 (A Phase I/II, Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of Engensis), which is not on this map. Cited by 20 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.
A Phase I/II, Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of Engensis (VM202) in Patients With Painful Diabetic Peripheral Neuropathy
Who cites it
20 citing papers in PubMed.
- Gene therapy for diabetic peripheral neuropathy: A randomized, placebo-controlled phase III study of VM202, a plasmid DNA encoding human hepatocyte growth factor.Clinical and translational science · 2021Trial
- Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia.Gene therapy · 2016Trial
- Angiogenic Gene Therapy for Lower Extremity Ischemia: Experimental Advances and Clinical Experience.Cells · 2026Review
- Diabetic neuropathy: cutting-edge research and future directions.Signal transduction and targeted therapy · 2025Review
- Novel rAAV vector mediated intrathecal HGF delivery has an impact on neuroimmune modulation in the ALS motor cortex with TDP-43 pathology.Gene therapy · 2023Article
- Stem cell therapy combined with controlled release of growth factors for the treatment of sphincter dysfunction.Cell & bioscience · 2023Review
- Designing electrospun fiber platforms for efficient delivery of genetic material and genome editing tools.Advanced drug delivery reviews · 2022Review
- Approaches to Modulate the Chronic Wound Environment Using Localized Nucleic Acid Delivery.Advances in wound care · 2021Review
- The Potential Role of Hepatocyte Growth Factor in Degenerative Disorders of the Synovial Joint and Spine.International journal of molecular sciences · 2020Review
- Efficacy of nonviral gene transfer of human hepatocyte growth factor (HGF) against ischemic-reperfusion nerve injury in rats.PloS one · 2020Article
- Multipotent Neurotrophic Effects of Hepatocyte Growth Factor in Spinal Cord Injury.International journal of molecular sciences · 2019Review
- Intrathecal delivery of recombinant AAV1 encoding hepatocyte growth factor improves motor functions and protects neuromuscular system in the nerve crush and SOD1-G93A transgenic mouse models.Acta neuropathologica communications · 2019Article
- Hepatocyte Growth Factor Regulates the miR-206-HDAC4 Cascade to Control Neurogenic Muscle Atrophy following Surgical Denervation in Mice.Molecular therapy. Nucleic acids · 2018Article
- Effective control of neuropathic pain by transient expression of hepatocyte growth factor in a mouse chronic constriction injury model.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2018Article
- Bone Marrow-Derived Mesenchymal Stem Cells Improve Diabetic Neuropathy by Direct Modulation of Both Angiogenesis and Myelination in Peripheral Nerves.Cell transplantation · 2016Article
- Exploratory study for identifying systemic biomarkers that correlate with pain response in patients with intervertebral disc disorders.Immunologic research · 2015Article
- Measuring Therapy-Induced Peripheral Neuropathy: Preliminary Development and Validation of the Treatment-Induced Neuropathy Assessment Scale.The journal of pain · 2015Article
- Double-blind, placebo-controlled study of HGF gene therapy in diabetic neuropathy.Annals of clinical and translational neurology · 2015Article
- Hepatocyte Growth Factor Isoforms in Tissue Repair, Cancer, and Fibrotic Remodeling.Biomedicines · 2014Review
- New and developing drugs for the treatment of neuropathic pain in diabetes.Current diabetes reports · 2013Review
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
This study aimed to evaluate the safety and preliminary efficacy of intramuscular injections of plasmid DNA (VM202) expressing two isoforms of hepatocyte growth factor (HGF) in subjects with painful diabetic peripheral neuropathy (PDPN). Twelve patients in three cohorts (4, 8, and 16 mg) received two sets of VM202 injections separated by two weeks. Safety and tolerability were evaluated and the visual analog scale (VAS), the short form McGill questionnaire (SF-MPQ), and the brief pain inventory for patients with diabetic peripheral neuropathy (BPI-DPN) measured pain level throughout 12 months after treatment. No serious adverse events (AEs) were observed. The mean VAS was reduced from baseline by 47.2% (P = 0.002) at 6 months and by 44.1% (P = 0.005) at 12 months after treatment. The VAS scores for the 4, 8, and 16 mg dose cohorts at 6 months follow-up decreased in a dose-responsive manner, by 21% (P = 0.971), 53% (P = 0.014), and 62% (P = 0.001), respectively. The results with the BPI-DPN and SF-MPQ showed patterns similar to the VAS scores. In conclusion, VM202 treatment appeared to be safe, well tolerated, and sufficient to provide long term symptomatic relief and improvement in the quality of life in patients with PDPN.
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Registered trials
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