Volume 13 Issue 9
Sep.  2023
Turn off MathJax
Article Contents
Article Navigation >  Journal of Pharmaceutical Analysis  > 2023  >  13(9): 960-967
Leeann Yao, Dejan Bojic, Mingyao Liu. Applications and safety of gold nanoparticles as therapeutic devices in clinical trials[J]. Journal of Pharmaceutical Analysis, 2023, 13(9): 960-967. doi: 10.1016/j.jpha.2023.06.001
Citation: Leeann Yao, Dejan Bojic, Mingyao Liu. Applications and safety of gold nanoparticles as therapeutic devices in clinical trials[J]. Journal of Pharmaceutical Analysis, 2023, 13(9): 960-967. doi: 10.1016/j.jpha.2023.06.001
shu

Applications and safety of gold nanoparticles as therapeutic devices in clinical trials

doi: 10.1016/j.jpha.2023.06.001

  • a. Latner Thoracic Surgical Research Laboratories, Toronto General Hospital Research Institute, University Health Network, Toronto, ON, M5G 1L7, Canada;

  • b. Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, M5S 1A8, Canada;

  • c. Department of Surgery, Medicine and Physiology, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, M5S 1A8, Canada

Funds:

This research was supported by grants from Canadian Institutes of Health Research (Grant Nos.: MOP-42546, MOP-119514, PJT-148847).

  • Received Date: Feb. 14, 2023
  • Accepted Date: Jun. 02, 2023
  • Rev Recd Date: May 26, 2023
  • Publish Date: Jun. 04, 2023
    Abstract
  • Use of gold nanoparticles (GNPs) in medicine is an emerging field of translational research with vast clinical implications and exciting therapeutic potential. However, the safety of using GNPs in human subjects is an important question that remains unanswered. This study reviews over 20 clinical trials focused on GNP safety and aims to summarize all the clinical studies, completed and ongoing, to identify whether GNPs are safe to use in humans as a therapeutic platform. In these studies, GNPs were implemented as drug delivery devices, for photothermal therapy, and utilized for their intrinsic therapeutic effects by various routes of delivery. These studies revealed no major safety concerns with the use of GNPs; however, the number of trials and total patient number remains limited. Multi-dose, multi-center blinded trials are required to deepen our understanding of the use of GNPs in clinical settings to facilitate translation of this novel, multifaceted therapeutic device. Expanding clinical trials will require collaboration between clinicians, scientists, and biotechnology companies.
    • FullText(HTML)
  • loading
    • References(78)
  • M.B. Chaudhari, P.P. Desai, P.A. Patel, et al., Solid lipid nanoparticles of amphotericin B (AmbiOnp): In vitro and in vivo assessment towards safe and effective oral treatment module, Drug Deliv. Transl. Res. 6 (2016) 354-364.
    C. Campanella, C. Caruso Bavisotto, M. Logozzi, et al., On the choice of the extracellular vesicles for therapeutic purposes, Int. J. Mol. Sci. 20 (2019), 236.
    A.C. Anselmo, S. Mitragotri, A Review of Clinical Translation of Inorganic Nanoparticles, AAPS J. 17 (2015) 1041-1054.
    M. Mir, S. Ishtiaq, S. Rabia, et al., Nanotechnology: From In Vivo Imaging System to Controlled Drug Delivery, Nanoscale Res. Lett. 12 (2017), 500.
    Y.-C. Yeh, B. Creran, V.M. Rotello, Gold nanoparticles: Preparation, properties, and applications in bionanotechnology, Nanoscale 4 (2012) 1871-1880.
    A. Kumar, X. Zhang, X.-J. Liang, Gold nanoparticles: Emerging paradigm for targeted drug delivery system, Biotechnol. Adv. 31 (2013) 593-606.
    A. Majdalawieh, M.C. Kanan, O. El-Kadri, et al., Recent advances in gold and silver nanoparticles: Synthesis and applications, J. Nanosci. Nanotechnol. 14 (2014) 4757-4780.
    Y. Li, S. Liu, T. Yao, et al., Controllable synthesis of gold nanoparticles with ultrasmall size and high monodispersity via continuous supplement of precursor, Dalton Trans. 41 (2012) 11725-11730.
    M. Grzelczak, J. Perez-Juste, P. Mulvaney, et al., Shape control in gold nanoparticle synthesis, Chem. Soc. Rev. 37 (2008) 1783-1791.
    L.A. Dykman, N.G. Khlebtsov, Gold nanoparticles in biology and medicine: recent advances and prospects, Acta Naturae 3 (2011) 34-55.
    J.D.E.T. Wilton-Ely, The surface functionalisation of gold nanoparticles with metal complexes, Dalton Trans. (2008) 25-29.
    A.S. Thakor, J. Jokerst, C. Zavaleta, et al., Gold nanoparticles: A revival in precious metal administration to patients, Nano Lett. 11 (2011) 4029-4036.
    A. Liang, Q. Liu, G. Wen, et al., The surface-plasmon-resonance effect of nanogold/silver and its analytical applications, TrAC Trends Anal. Chem. 37 (2012) 32-47.
    H. Yang, S.-Y. Fung, M. Liu, Programming the cellular uptake of physiologically stable peptide-gold nanoparticle hybrids with single amino acids, Angew. Chem. Int. Ed. 50 (2011) 9643-9646.
    P. Singh, S. Pandit, V.R.S.S. Mokkapati, et al., Gold nanoparticles in diagnostics and therapeutics for human cancer, Int. J. Mol. Sci. 19 (2018), 1979.
    S. Sindhwani, A.M. Syed, J. Ngai, et al., The entry of nanoparticles into solid tumours, Nat. Mater. 19 (2020) 566-575.
    M. Zhao, M. Liu, New Avenues for Nanoparticle-Related Therapies, Nanoscale Res. Lett. 13 (2018), 136.
    I. Javed, S.Z. Hussain, A. Shahzad, et al., Lecithin-gold hybrid nanocarriers as efficient and pH selective vehicles for oral delivery of diacerein-In-vitro and in-vivo study, Colloids Surf. B. 141 (2016) 1-9.
    B.R. Dalvi, E.A. Siddiqui, A.S. Syed, et al., Nevirapine Loaded Core Shell Gold Nanoparticles by Double Emulsion Solvent Evaporation: In vitro and In vivo Evaluation, Curr. Drug Deliv. 13 (2016) 1071-1083.
    I. Somasuntharam, K. Yehl, S.L. Carroll, et al., Knockdown of TNF-α by DNAzyme gold nanoparticles as an anti-inflammatory therapy for myocardial infarction, Biomaterials 83 (2016) 12-22.
    K. Chaudhary, H. Moore, A. Tandon, et al., Nanotechnology and adeno-associated virus-based decorin gene therapy ameliorates peritoneal fibrosis, Am. J. Physiol. Ren. Physiol. 307 (2014) F777-F782.
    W. Chen, W. Zeng, J. Sun, et al., Construction of an Aptamer-SiRNA Chimera-Modified Tissue-Engineered Blood Vessel for Cell-Type-Specific Capture and Delivery, ACS Nano 9 (2015) 6069-6076.
    H. Nemati, M.-H. Ghahramani, R. Faridi-Majidi, et al., Using siRNA-based spherical nucleic acid nanoparticle conjugates for gene regulation in psoriasis, J. Control. Release 268 (2017) 259-268.
    K.Y.J. Lee, G.Y. Lee, L.A. Lane, et al., Functionalized, long-circulating, and ultrasmall gold nanocarriers for overcoming the barriers of low nanoparticle delivery efficiency and poor tumor penetration, Bioconj. Chem. 28 (2017) 244-252.
    T. Bhowmik, P.P. Saha, A. Sarkar, et al., Evaluation of cytotoxicity of a purified venom protein from Naja kaouthia (NKCT1) using gold nanoparticles for targeted delivery to cancer cell, Chem. Biol. Interact. 261 (2017) 35-49.
    H. Hua, N. Zhang, D. Liu, et al., Multifunctional gold nanorods and docetaxel-encapsulated liposomes for combined thermo-and chemotherapy, Int. J. Nanomed. 12 (2017) 7869-7884.
    R. Heo, H.Y. Yoon, H. Ko, et al., Gold-installed biostable nanocomplexes for tumor-targeted siRNA delivery in vivo, Chem. Commun. 51 (2015) 16656-16659.
    E.S. Davidi, T. Dreifuss, M. Motiei, et al., Cisplatin-conjugated gold nanoparticles as a theranostic agent for head and neck cancer, Head Neck 40 (2018) 70-78.
    S.K. Libutti, G.F. Paciotti, A.A. Byrnes, et al., Phase I and pharmacokinetic studies of CYT-6091, a novel PEGylated colloidal gold-rhTNF nanomedicine, Clin. Cancer Res. 16 (2010) 6139-6149.
    P. Kumthekar, C.H. Ko, T. Paunesku, et al., A first-in-human phase 0 clinical study of RNA interference-based spherical nucleic acids in patients with recurrent glioblastoma, Sci. Transl. Med. 13 (2021), eabb3945.
    D. Tatovic, M.A. McAteer, J. Barry, et al., Safety of the use of gold nanoparticles conjugated with proinsulin peptide and administered by hollow microneedles as an immunotherapy in type 1 diabetes, Immunother. Advanc. 2 (2022), ltac002.
    M. Khoobchandani, K.K. Katti, A.R. Karikachery, et al., New approaches in breast cancer therapy through green nanotechnology and nano-ayurvedic medicine-pre-clinical and pilot human clinical investigations, Int. J. Nanomed. 15 (2020) 181-197.
    N. Nilubol, Z. Yuan, G.F. Paciotti, et al., Novel dual-action targeted nanomedicine in mice with metastatic thyroid cancer and pancreatic neuroendocrine tumors, J. Natl. Cancer Inst. 110 (2018) 1019-1029.
    J.B. Vines, J.-H. Yoon, N.-E. Ryu, et al., Gold Nanoparticles for Photothermal Cancer Therapy, Front. Chem. 7 (2019), 167.
    A.N. Kharlamov, A.E. Tyurnina, V.S. Veselova, et al., Silica-gold nanoparticles for atheroprotective management of plaques: Results of the NANOM-FIM trial, Nanoscale 7 (2015) 8003-8015.
    A.N. Kharlamov, J.A. Feinstein, J.A. Cramer, et al., Plasmonic photothermal therapy of atherosclerosis with nanoparticles: Long-term outcomes and safety in NANOM-FIM trial, Future Cardiol. 13 (2017) 345-363.
    J.M. Stern, V.V. Kibanov Solomonov, E. Sazykina, et al., Initial Evaluation of the Safety of Nanoshell-Directed Photothermal Therapy in the Treatment of Prostate Disease, Int. J. Toxicol. 35 (2016) 38-46.
    A.R. Rastinehad, H. Anastos, E. Wajswol, et al., Gold nanoshell-localized photothermal ablation of prostate tumors in a clinical pilot device study, Proc. Natl. Acad. Sci. U.S.A. 116 (2019) 18590-18596.
    D. Paithankar, B.H. Hwang, G. Munavalli, et al., Ultrasonic delivery of silica-gold nanoshells for photothermolysis of sebaceous glands in humans: Nanotechnology from the bench to clinic, J. Control. Release 206 (2015) 30-36.
    Y. Pang, C. Wei, R. Li, et al., Photothermal conversion hydrogel based mini-eye patch for relieving dry eye with long-term use of the light-emitting screen, Int. J. Nanomed. 14 (2019) 5125-5133.
    ClinicalTrials.gov, MRI/US Fusion Imaging and Biopsy in Combination with Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue. https://clinicaltrials.gov/ct2/show/NCT02680535. (Accessed 22 April 2023).
    ClinicalTrials.gov, An Extension Study MRI/US Fusion Imaging and Biopsy in Combination with Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue. https://clinicaltrials.gov/ct2/show/NCT04240639. (Accessed 22 April 2023).
    ClinicalTrials.gov, Efficacy Study of AuroLase Therapy in Subjects with Primary and/or Metastatic Lung Tumors. https://www.clinicaltrials.gov/ct2/show/NCT01679470. (Accessed 22 April 2023).
    ClinicalTrials.gov, Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck. https://clinicaltrials.gov/ct2/show/NCT00848042. (Accessed 22 April 2023).
    ClinicalTrials.gov, Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris. https://clinicaltrials.gov/ct2/show/NCT02219074. (Accessed 22 April 2023).
    T. Hayashi, K. Tanaka, M. Haruta, Selective vapor-phase epoxidation of propylene over Au/TiO2 catalysts in the presence of oxygen and hydrogen, J. Catal. 178 (1998) 566-575.
    X. Shen, W. Liu, X. Gao, et al., Mechanisms of Oxidase and Superoxide Dismutation-like Activities of Gold, Silver, Platinum, and Palladium, and Their Alloys: A General Way to the Activation of Molecular Oxygen, J. Am. Chem. Soc. 137 (2015) 15882-15891.
    X. Huang, I.H. El-Sayed, X. Yi, et al., Gold nanoparticles: Catalyst for the oxidation of NADH to NAD+, J. Photochem. Photobiol. B 81 (2005) 76-83.
    C. Canto, K.J. Menzies, J. Auwerx, NAD(+) Metabolism and the control of energy homeostasis: A balancing act between mitochondria and the nucleus, Cell Metab. 22 (2015) 31-53.
    U. Funfschilling, L.M. Supplie, D. Mahad, et al., Glycolytic oligodendrocytes maintain myelin and long-term axonal integrity, Nature 485 (2012) 517-521.
    M.B. Rone, Q.-L. Cui, J. Fang, et al., Oligodendrogliopathy in Multiple Sclerosis: Low Glycolytic Metabolic Rate Promotes Oligodendrocyte Survival, J. Neurosci. 36 (2016) 4698-4707.
    A.P. Robinson, J.Z. Zhang, H.E. Titus, et al., Nanocatalytic activity of clean-surfaced, faceted nanocrystalline gold enhances remyelination in animal models of multiple sclerosis, Sci. Rep. 10 (2020), 1936.
    ClinicalTrials.gov, A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers. https://clinicaltrials.gov/ct2/show/NCT02755870. (Accessed 21 April 2023).
    ClinicalTrials.gov, 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS) (REPAIR-ALS). https://clinicaltrials.gov/ct2/show/NCT03843710. (Accessed 21 April 2023).
    ClinicalTrials.gov, 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis. (REPAIR-MS). https://clinicaltrials.gov/ct2/show/NCT03993171. (Accessed 22 April 2023).
    ClinicalTrials.gov, 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson’s Disease (REPAIR-PD). https://clinicaltrials.gov/ct2/show/NCT03815916. (Accessed 22 April 2023).
    ClinicalTrials.gov, Intermediate Expanded Access Protocol for ALS. https://clinicaltrials.gov/ct2/show/NCT04081714. (Accessed 22 April 2023).
    ClinicalTrials.gov, HEALEY ALS Platform Trial - Regimen C CNM-Au8. https://clinicaltrials.gov/ct2/show/NCT04414345. (Accessed 22 April 2023).
    ClinicalTrials.gov, HEALEY ALS Platform Trial - Master Protocol. https://clinicaltrials.gov/ct2/show/NCT04297683. (Accessed 22 April 2023).
    ClinicalTrials.gov, Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS) (RESCUE-ALS). https://clinicaltrials.gov/ct2/show/NCT04098406. (Accessed 22 April 2023).
    ClinicalTrials.gov, Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy in Multiple Sclerosis (VISIONARY-MS). https://clinicaltrials.gov/ct2/show/NCT03536559. (Accessed 22 April 2023).
    ClinicalTrials.gov, A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 in Patients with Stable Relapsing Multiple Sclerosis (VISIONMS-LTE). https://clinicaltrials.gov/ct2/show/NCT04626921. (Accessed 22 April 2023).
    R. Goel, N. Shah, R. Visaria, et al., Biodistribution of TNF-α-coated gold nanoparticles in an in vivo model system, Nanomedicine (Lond). 4 (2009) 401-410.
    H. Yang, Y. Zhou, S.-Y. Fung, et al., Amino Acid Structure Determines the Immune Responses Generated by Peptide-Gold Nanoparticle Hybrids, Part. Part. Syst. Charact. 30 (2013) 1039-1043.
    H. Yang, S.-Y. Fung, S. Xu, et al., Amino Acid-Dependent Attenuation of Toll-like Receptor Signaling by Peptide-Gold Nanoparticle Hybrids, ACS Nano 9 (2015) 6774-6784.
    D. Lee, J. Zhao, H. Yang, et al., Effective delivery of a rationally designed intracellular peptide drug with gold nanoparticle-peptide hybrids, Nanoscale 7 (2015) 12356-12360.
    D.P. Cormode, P.C. Naha, Z.A. Fayad, Nanoparticle contrast agents for computed tomography: A focus on micelles, Contrast Media Mol. Imaging 9 (2014) 37-52.
    Q.-Y. Cai, S.H. Kim, K.S. Choi, et al., Colloidal gold nanoparticles as a blood-pool contrast agent for X-ray computed tomography in mice, Investig. Radiol. 42 (2007) 797-806.
    D. Kim, S. Park, J.H. Lee, et al., Antibiofouling polymer-coated gold nanoparticles as a contrast agent for in vivo X-ray computed tomography imaging, J. Am. Chem. Soc. 129 (2007) 7661-7665.
    Y.C. Dong, M. Hajfathalian, P.S.N. Maidment, et al., Effect of Gold Nanoparticle Size on Their Properties as Contrast Agents for Computed Tomography, Sci. Rep. 9 (2019), 14912.
    L. Moriggi, C. Cannizzo, E. Dumas, et al., Gold nanoparticles functionalized with gadolinium chelates as high-relaxivity MRI contrast agents, J. Am. Chem. Soc. 131 (2009) 10828-10829.
    M. Shahid, Water soluble gold nanoparticles based high relaxivity MRI contrast agents, Mater. Res. Express 6 (2019), 1250h1.
    S. Penninckx, A.-C. Heuskin, C. Michiels, et al., Gold Nanoparticles as a Potent Radiosensitizer: A Transdisciplinary Approach from Physics to Patient, Cancers 12 (2020), 2021.
    W. He, Y.-T. Zhou, W.G. Wamer, et al., Intrinsic catalytic activity of Au nanoparticles with respect to hydrogen peroxide decomposition and superoxide scavenging, Biomaterials 34 (2013) 765-773.
    Y. Lin, J. Ren, X. Qu, Nano-gold as artificial enzymes: Hidden talents, Adv. Mater. 26 (2014) 4200-4217.
    A.A. Khan, A.H. Rahmani, Y.H. Aldebasi, et al., Biochemical and pathological studies on peroxidases-an updated review, Glob. J. Health Sci. 6 (2014) 87-98.
    L. Goth, P. Rass, A. Pay, Catalase enzyme mutations and their association with diseases, Mol. Diagn. 8 (2004) 141-149.
    National Nanotechnology Initiative, National Nanotechnology Initiative Supplement to the President’s 2021 Budget. https://www.nano.gov/sites/default/files/pub_resource/NNI-FY21-Budget-Supplement.pdf. (Accessed 21 April 2023).
    • Relative Articles
    • Supplements(0)
    • Cited By
  • 加载中

Catalog

    通讯作者: 陈斌, bchen63@163.com
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Figures(1)

    Get Citation
    PDF
    XML

    Article Metrics

    Article views (400) PDF downloads(25) Cited by()
    Proportional views
    Related

    Copyright © Journal of Pharmaceutical Analysis

    E-mail: jpa2011@126.com;  jpasubmit@126.com;  jpaeditor@xjtu.edu.cn   Tel:+86-029-88960092

    Address: Western China Science and Technology Innovation Harbour, Xixian New Area, Xi’an, 712000, China

    Email alert RSS

    Supported by: Beijing Renhe Information Technology Co. Ltd    

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return