ArticleGene therapy2011
Safety of a non-viral plasmid-encoding dual isoforms of hepatocyte growth factor in critical limb ischemia patients: a phase I study.
Article in Gene therapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00696124 (Phase 1, Dose-Escalation Study to Assess the Safety and Tolerability of VM202), which is not on this map. Cited by 31 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Phase 1, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 (Engensis) in Subjects With Critical Limb Ischemia
Who cites it
31 citing papers in PubMed, 76 citations in OpenAlex.
- Hepatocyte growth factor for walking performance in peripheral artery disease.Journal of vascular surgery · 2025Trial
- Complementary Gene Therapy after Revascularization with the Saphenous Vein in Diabetic Foot Syndrome.Genes · 2023Trial
- 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
- A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Hepatocyte Growth Factor in the Treatment of Critical Limb Ischemia.Molecular therapy : the journal of the American Society of Gene Therapy · 2019Trial
- Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia.Gene therapy · 2016Trial
- 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.Molecular therapy : the journal of the American Society of Gene Therapy · 2013Trial
- DNA-mediated UCP1 overexpression in adipose tissue: A promising anti-obesity gene therapy.Clinical and translational medicine · 2025Article
- Gene therapy for polygenic or complex diseases.Biomarker research · 2024Review
- Gene therapy for diabetic foot ulcers: Interim analysis of a randomised, placebo-controlled phase 3 study of VM202 (ENGENSIS), a plasmid DNA expressing two isoforms of human hepatocyte growth factor.International wound journal · 2023Article
- CMT1A current gene therapy approaches and promising biomarkers.Neural regeneration research · 2023Review
- Review
- Stem cell therapy combined with controlled release of growth factors for the treatment of sphincter dysfunction.Cell & bioscience · 2023Review
- Characteristics and Outcomes of Clinical Trials on Gene Therapy in Noncongenital Cardiovascular Diseases: Cross-sectional Study of Three Clinical Trial Registries.JMIR formative research · 2022Article
- Designing electrospun fiber platforms for efficient delivery of genetic material and genome editing tools.Advanced drug delivery reviews · 2022Review
- A Thermoresponsive Chitosan/β-Glycerophosphate Hydrogel for Minimally Invasive Treatment of Critical Limb Ischaemia.Polymers · 2021Article
- Emerging Therapies for Charcot-Marie-Tooth Inherited Neuropathies.International journal of molecular sciences · 2021Review
- Is gene therapy for limb ischemia a reality?Jornal vascular brasileiro · 2020Review
- 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
- 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
- Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We aimed to evaluate in a phase I dose-escalation study, the safety of intramuscular injections of a novel non-viral plasmid DNA expressing two isoforms of human hepatocyte growth factor (HGF) (VM202) in patients with critical limb ischemia (CLI). In total, 12 patients with CLI and unsuitable for revascularization were consecutively assigned to increasing doses (2 to 16 mg) of VM202 administered into the ischemic calf muscle at days 1 and 15. Patients were evaluated for safety and tolerability, changes in ankle- and toe brachial index (ABI and TBI), and pain severity score using a visual analog scale (VAS) throughout a 12-month follow-up period. Median age was 72 years and 53% of the patients were male. VM202 was safe and well tolerated with no death during the 12-month follow-up. Median ABI and TBI significantly increased from 0.35 to 0.52 (P=0.005) and from 0.15 to 0.24 (P=0.01) at 12 months follow-up. Median VAS decreased from 57.5 to 16.0 mm at 6 months follow-up (P=0.03). In this first human clinical trial, VM202, which expresses two isoforms of human HGF, appear to be safe and well tolerated with encouraging clinical results and thus supports the performance of a phase II randomized controlled trial.
Indexed as
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.