Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2019
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Hepatocyte Growth Factor in the Treatment of Critical Limb Ischemia.
Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
What it found
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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.
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Who cites it
23 citing papers in PubMed, 45 citations in OpenAlex.
- Seltoplasmid promotes ulcer healing versus placebo for treating patients with chronic limb-threatening ischemia: HOPE CLTI-2 trial.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Trial
- Angiogenic Gene Therapy for Lower Extremity Ischemia: Experimental Advances and Clinical Experience.Cells · 2026Review
- Analgesic strategies for ischaemic pain in chronic limb-threatening ischaemia: a systematic review and meta-analysis.Pain reports · 2026Review
- DNA-mediated UCP1 overexpression in adipose tissue: A promising anti-obesity gene therapy.Clinical and translational medicine · 2025Article
- CYB5R4 sustains endothelial proliferation and ischemia-induced angiogenesis by maintaining RRM2-dependent nucleotide balance.bioRxiv : the preprint server for biology · 2025Article
- Extended Toxicity, Genotoxicity, and Mutagenicity of Combination of pBudK-coVEGF-coANG and pBudK-coGDNF Plasmids in Preclinical Trials.Biomedicines · 2025Article
- Gene therapy for chronic pain management.Cell reports. Medicine · 2024Review
- Gene therapy for polygenic or complex diseases.Biomarker research · 2024Review
- Gene therapy by virus-like self-spooling toroidal DNA condensates for revascularization of hindlimb ischemia.Journal of nanobiotechnology · 2024Article
- Review
- Therapeutic angiogenesis for patients with chronic limb-threatening ischemia: promising or hoax?Vascular biology (Bristol, England) · 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
- Therapeutic angiogenesis and tissue revascularization in ischemic vascular disease.Journal of biological engineering · 2023Review
- Diabetic foot ulcer: Challenges and future.World journal of diabetes · 2022Review
- Update on the pathophysiology and medical treatment of peripheral artery disease.Nature reviews. Cardiology · 2022Review
- 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
- Gene Therapy of Chronic Limb-Threatening Ischemia: Vascular Medical Perspectives.Journal of clinical medicine · 2022Review
- Advances for the treatment of lower extremity arterial disease associated with diabetes mellitus.Frontiers in molecular biosciences · 2022Review
- Overcoming ischemia in the diabetic foot: Minimally invasive treatment options.World journal of diabetes · 2021Review
- Comprehensive Assessment of Current Management Strategies for Patients With Diabetes and Chronic Limb-Threatening Ischemia.Clinical diabetes : a publication of the American Diabetes Association · 2021Article
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Authors and funding
12 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
NL003 is a plasmid engineered to simultaneously express two isoforms of hepatocyte growth factor. This phase II study was performed to assess the clinical safety and efficacy of intramuscular injection of NL003 in critical limb ischemia (CLI) patients for 6 months. Two hundred patients (Rutherford scale 4-5) were randomly assigned: placebo (n = 50), low-dose NL003 (n = 50), middle-dose NL003 (n = 50), or high-dose NL003 (n = 50). The drug was administered in the affected limb of 197 patients on days 0, 14, and 28. No significant differences in the incidence of adverse events (AEs) or serious AEs were found among the groups. At 6 months, pain severity was significantly reduced in all NL003 groups, but not in the placebo group (p < 0.05). The proportion of patients with complete ulcer healing in the high-dose group was significantly higher than that of the placebo group (p = 0.0095). There were no statistically significant differences in transcutaneous oxygen pressure (TcPO
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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.