1. A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Hepatocyte Growth Factor in the Treatment of Critical Limb Ischemia
- Author
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Qi Wang, Chengquan Han, Shijun Cui, Chang Shu, Wei Guo, Tongbin Chu, Fuxian Zhang, Yue Liu, Changwei Liu, Yongquan Gu, Bi Jin, and Changjian Liu
- Subjects
Male ,medicine.medical_specialty ,Genetic enhancement ,Phases of clinical research ,Placebo ,Injections, Intramuscular ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Ischemia ,Internal medicine ,Drug Discovery ,Genetics ,Humans ,Medicine ,Adverse effect ,Molecular Biology ,030304 developmental biology ,Pharmacology ,Leg ,0303 health sciences ,Hepatocyte Growth Factor ,business.industry ,Incidence (epidemiology) ,Genetic Therapy ,Critical limb ischemia ,Middle Aged ,Prognosis ,Editorial ,030220 oncology & carcinogenesis ,Molecular Medicine ,Female ,Hepatocyte growth factor ,medicine.symptom ,business ,Intramuscular injection ,Follow-Up Studies ,Plasmids ,medicine.drug - 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
- Published
- 2019