The Phase I Study of Recombinant Human Nerve Growth Factor Injection in Healthy Chinese Volunteers on Safety, Tolerability and Pharmacokinetics: Randomized, Double-blind, Placebo-controlled, Single / Multiple Dose

A randomized, double-blind, placebo-controlled, single/multiple dose study of recombinant human nerve growth factor injection in healthy Chinese volunteers on safety, tolerability and pharmacokinetics

开始日期2019-12-26

申办/合作机构

首都医科大学附属北京同仁医院

100 项与 Recombinant human nerve growth factor(Beijing Tongren Hospital) 相关的临床结果

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100 项与 Recombinant human nerve growth factor(Beijing Tongren Hospital) 相关的转化医学

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100 项与 Recombinant human nerve growth factor(Beijing Tongren Hospital) 相关的专利（医药）

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项与 Recombinant human nerve growth factor(Beijing Tongren Hospital) 相关的文献（医药）

2024-10-01·Reproduction in Domestic Animals

Influence of free and microencapsulated recombinant rabbit nerve growth factor with chitosan on rabbit sperm quality parameters

Article

作者: Arias‐Alvarez, María ; Lorenzo, Pedro Luis ; Castellini, Cesare ; Gimeno‐Martos, Silvia ; Bosa, Luigia ; García‐García, Rosa María ; García‐Rebollar, Pilar

Abstractβ‐nerve growth factor (βNGF) plays a crucial role in reproductive physiology and sperm quality. Enzymatic activity of seminal plasma and vaginal fluids reduces available βNGF and it has been demonstrated that chitosan microspheres could protect rrβNGF from degradation. This study examined the effects of microencapsulated rrbNGF with chitosan on rabbit sperm viability, motility and capacitation status. Results showed that 0.5 and 1 μg/mL of microencapsulated rrβNGF, as well as free rrβNGF or empty microspheres, did not adversely affect sperm viability or total motility after 2 h of incubation. However, the highest progressivity kinetic parameters were observed with 1 μg/mL free rrβNGF, while the highest curvilinear velocity (VCL) occurred with 0.5 μg/mL microencapsulated rrβNGF. Empty chitosan microspheres did not induce acrosome reaction (AR), but both concentrations of free and rrβNGFch favoured AR during in vitro incubation. The study suggests that using chitosan spheres did not show any adverse effects on sperm traits, unlike free rβNGF and rrβNGFch promoted capacitation and AR. Further research is needed to explore the potential of rrβNGFch in modifying in vitro capacitation and inducing ovulation during artificial insemination.

2024-09-01·European review for medical and pharmacological sciences

Intranasal human-recombinant nerve growth factor administration improves cognitive functions in a child with severe traumatic brain injury.

Article

作者: Soligo, M ; Romeo, D M ; Gatto, A ; Di Sarno, L ; Napoli, E ; Cocciolillo, F ; Staccioli, S ; Manni, L ; Ferretti, S ; Calcagni, M L ; Chiaretti, A ; Capossela, L ; Di Giuda, D ; Graglia, B

BACKGROUNDBehavioral and neuropsychological functions are frequent long-term sequelae of severe traumatic brain injury (TBI). Neuropeptides, such as nerve growth factor (NGF), can enhance neurogenesis and improve cognitive functions after TBI, playing a pivotal role in neuroplasticity. A limited number of studies documented the safety and efficacy of intranasal NGF administration in children with severe TBI.CASE REPORTA fourteen-year-old boy with a diffuse axonal injury secondary to severe TBI was treated with human-recombinant NGF administration. This patient underwent treatment with intranasal hr-NGF administration at a total dose of 50 gamma/kg, three times a day for seven consecutive days. The treatment schedule was performed for 4 cycles, at one month distance each. NGF administration improved radiologic functional assessment evaluated with positron emission tomography scan (PET) and single photon emission computed tomography (SPECT), with an important improvement in clinical conditions. Significant improvements were also observed, mainly in cognitive processes, memory, the planning of a communication strategy, execution skills, attention, and verbal expression. No side effects were reported.CONCLUSIONSAdditional studies are required to gain a deeper insight into this neurotrophin's neuroprotective function, but our findings reveal a potential efficacy of intranasal hr-NGF administration in enhancing cognitive and clinical outcomes among children with diffuse axonal injury after severe TBI.

2024-07-01·Cornea

Corneal Superficial Plaque Formation After Recombinant Human Nerve Growth Factor Use in a Patient With Neurotrophic Keratopathy and Limbal Stem Cell Deficiency From Mucous Membrane Pemphigoid

Article

作者: Lin, Julie ; Surico, Pier Luigi ; Kaufman, Aaron R. ; Kaufman, Aaron R ; Dehghani, Shima ; Dana, Reza

Purpose:The aim of this study was to report a rare observation of corneal superficial plaque formation after topical recombinant human nerve growth factor (rhNGF) treatment for a nonhealing epithelial defect in a patient with advanced mucous membrane pemphigoid, limbal stem cell deficiency, and neurotrophic keratopathy.Methods:This study was a case report.Results:A 72-year-old man with a complex course of mucous membrane pemphigoid, leading to cicatrizing keratoconjunctivits, limbal stem cell deficiency, and neurotrophic keratopathy presented with a recurrent persistent epithelial defect in the right eye. After a long course of unsuccessful epithelial healing, despite various treatment modalities, he was administered topical rhNGF (cenegermin 0.002%; Oxervate, Dompé US Inc., Boston, MA) which successfully resolved the epithelial defect. However, on day 22 posttreatment, an unusual white, thick, adherent corneal superficial plaque formed. rhNGF was stopped and the plaque was carefully removed. Subsequently, there was no recurrence, and the patient's epithelial healing remained stable.Conclusions:Although the successful resolution of the persistent epithelial defect with rhNGF administration was notable, the development of the unusual epithelial overgrowth emphasizes the importance of vigilant monitoring and evaluation when using rhNGF in complex ocular conditions. Making informed decisions on the timing of discontinuing rhNGF can lead to desirable effects of the drug while mitigating additional side effects when managing such challenging cases.

100 项与 Recombinant human nerve growth factor(Beijing Tongren Hospital) 相关的药物交易

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