Development of biodegradable radiopaque microsphere for arterial embolization-a pig study

Liu, Yi‐Sheng; Lin, Xi‐Zhang; Tsai, Hong‐Ming; Tsai, Hung‐Wen; Chen, Syuan-Fong; Kang, Jui-Wen; Chou, Chen-Miao; Chen, Chiung‐Yu

doi:10.4329/wjr.v7.i8.212

Cited by 11 publications

(8 citation statements)

References 18 publications

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“…Thus, various biodegradable embolic materials have been developed. In our previous study, the new biodegradable microspheres SCBRM that we developed showed promising safety and efficacy in pigs [ 19 ]. In the present feasibility study, we further explored the safety and efficacy of SCBRM in BCLC-B HCC patients.…”

Section: Discussionmentioning

confidence: 99%

“…The new SCBRM were constructed as previously reported [ 19 ]. SCBRM were constructed using water insoluble and biodegradable excipients, including cetyl alcohol, cholesterol, glycol monostearate, Lipiodol ® , polycaprolactone, and stearyl acid.…”

Section: Methodsmentioning

confidence: 99%

“…Recently, we developed a new type of spherical, calibrated, biodegradable, radiopaque microspheres (SCBRM) with a size of 100–250 μm. SCBRM showed temporary arterial embolization of the liver and spleen of pigs, and its effect and safety were equivalent to or better than those of both Gelfoam ® and Embosphere ® [ 19 ]. Thus, the aim of this feasibility study was to evaluate the safety and efficacy of SCBRM in HCC patients with BCLC-B stage cancer.…”

Section: Introductionmentioning

confidence: 99%

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Safety and effectiveness of new embolization microspheres SCBRM for intermediate-stage hepatocellular carcinoma: A feasibility study

Liu

Lin

Chen

et al. 2020

Bosn J of Basic Med Sci

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Transarterial chemoembolization (TACE) is currently the recommended treatment for hepatocellular carcinoma (HCC). However, long-term chemoembolization triggers the inflammatory response and may lead to postembolization syndrome (PES). Although several types of degradable microspheres have been developed to reduce drug toxicity and PES incidence, the clinical outcomes remain unsatisfactory. Previously, we have developed a new type of spherical, calibrated, biodegradable, radiopaque microspheres (SCBRM) and demonstrated their safety and efficacy in a pig model. Thus, the goal of this feasibility study was to determine the clinical safety and efficacy of the new SCBRM in intermediate-stage HCC patients. In this study, 12 intermediate-stage HCC patients underwent TACE using SCBRM with a calibrated size of 100–250 μm. The disease control rates at 1 month and 3 months after TACE-SCBRM treatment were 100% and 75.0%, respectively. The objective response rates at 1 month and 3 months after treatment were 66.7% and 58.3%, respectively. Very few adverse events were observed with one patient developing nausea. One day after the treatment, alanine aminotransferase, alanine aminotransferase, and total bilirubin levels were slightly elevated in the patients, but all returned to baseline on day 7. The median and mean overall survival times were 33 months (interquartile range, 12.8–42.0) and 29.2 ± 14.3 months, respectively. The 1-year and 2-year survival rates were 91.7% and 58.3%, respectively. In conclusion, TACE with the new SCBRM microspheres is clinically safe and effective, and it represents a promising approach in the management of intermediate-stage HCC.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety and effectiveness of new embolization microspheres SCBRM for intermediate-stage hepatocellular carcinoma: A feasibility study

Liu

Lin

Chen

et al. 2020

Bosn J of Basic Med Sci

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“…However, TACE has some clear disadvantages with respect to HCC treatment; the creation of ischemic conditions at the tumor site promotes a proangiogenic response that enables the tumor to continue to thrive. Furthermore, two popular embolic materials—the DC Bead and HepaSphere—are not biodegradable, and long-term presence of DC Bead microspheres in the body may induce inflammation, thereby causing further tissue injury (Liu et al, 2015 ). In addition, the permanency of the microspheres limits the opportunity for the vessel recanalization required for repeating TACE procedures, and the drug release measured in vitro is incomplete for doxorubicin (DOX) loaded on the beads (Jordan et al, 2010 ).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Chitosan Derivative Microparticles Encapsulating Superparamagnetic Iron Oxide and Doxorubicin as a pH-Sensitive Delivery Carrier in Hepatic Carcinoma Treatment: An in vitro Comparison Study

et al. 2018

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We developed a novel, pH-sensitive drug delivery microparticle based on N-palmitoyl chitosan (NPCS) to transport the superparamagnetic iron oxide (SPIO) and anticancer drug doxorubicin (DOX). The characteristics of NPCS were characterized through nuclear magnetic resonance. Our results based on testing of volume swelling in multiple pH aqueous solutions revealed that the modified chitosan had a pH-sensitive property. The morphology and size of the DOX-SPIO/NPCS microparticles were investigated using transmission electron microscopy and scanning electron microscopy. The statistical result of microparticles had diameter of 185 ± 87 nm. Surface chemical moieties of DOX-SPIO/NPCS microparticles were confirmed using attenuated total reflection Fourier transform infrared spectroscopy and indicated the existence of mostly hydrophilic groups such as -OH, -C=O, and -C-O-C-. Transmission electron microscopy revealed the dark contrast of SPIO dots encapsulated in the NPCS matrix. Nuclear magnetic resonance T2-weighted magnetic resonance imaging confirmed that the produced DOX-SPIO/NPCS microparticles still exhibited T2 relaxation durations as short as 37.68 ± 8.69 ms (under administration of 2.5 μg/mL), which is comparable to the clinically required dosage. In the drug release profile, the DOX-SPIO/NPCS drug delivery microparticle was accelerated in an acidic environment (pH 6.5) compared with that in a basic environment. Microparticles in a cytotoxicity assay (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide assay) revealed that DOX-SPIO/NPCS microparticles had better antitumor ability than did free-form of DOX. Additionally, microparticles loaded with 0.5–5 μg/mL DOX in an acidic environment (pH 6.5) demonstrated higher efficacy against Hep G2 cell growth, possibly because of the swelling effect of NPCS, resulting in volume expansion and easy drug release. Accordingly, these large DOX-SPIO/NPCS microparticles showed potential for application as a pH-sensitive drug delivery system and as chemoembolization particles for hepatic carcinoma therapy.

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“…GELFOAM, a kind of nonspherical particles, is unable to precisely control the location of embolization. Besides, the recanalization time of GELFOAM is unpredictable as a temporary embolic agent [ 6 , 7 ]. In addition, Onyx is an expensive liquid embolic agent and may cause severe vasospasm if injected rapidly [ 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

Biocompatibility and Effectiveness Evaluation of a New Hemostatic Embolization Agent: Thrombin Loaded Alginate Calcium Microsphere

Xuan

Rong

Liang

et al. 2017

BioMed Research International

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Background. Until now, there has been no ideal embolization agent for hemorrhage in interventional treatment. In this study, the thrombin was encapsulated in alginate calcium microsphere using electrostatic droplet technique to produce new embolization agent: thrombin loaded alginate calcium microspheres (TACMs). Objectives. The present work was to evaluate the biocompatibility and hemostatic efficiency of TACMs. Methods. Cell cytotoxicity, hemolysis, and superselective embolization of dog liver arteries were performed to investigate the biocompatibility of TACMs. To clarify the embolic effect of TACMs mixed thrombus in vivo, hepatic artery injury animal model of 6 beagles was established and transcatheter artery embolization for bleeding was performed. Results. Coculture with VECs revealed the noncytotoxicity of TACMs, and the hemolysis experiment was negligible. Moreover, the histological study of TACMs in liver blood vessel showed signs of a slight inflammatory reaction. The results of transcatheter application of TACMs mixed thrombus for bleeding showed that the blood flow was shut down completely after the TACMs mixed thrombus was delivered and the postprocedural survival rate of animal models at 12 weeks was 100%. Conclusions. With their good biocompatibility and superior hemostatic efficiency, TACMs might be a promising new hemostatic agent with a wide range of potential applications.

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Development of biodegradable radiopaque microsphere for arterial embolization-a pig study

Abstract: Our microspheres, with the unique characteristics, can be used for transcatheter arterial embolization with effects equivalent to or better than Gelfoam and Embosphere in pigs.

Cited by 11 publications

References 18 publications

Safety and effectiveness of new embolization microspheres SCBRM for intermediate-stage hepatocellular carcinoma: A feasibility study

Safety and effectiveness of new embolization microspheres SCBRM for intermediate-stage hepatocellular carcinoma: A feasibility study

Evaluation of Chitosan Derivative Microparticles Encapsulating Superparamagnetic Iron Oxide and Doxorubicin as a pH-Sensitive Delivery Carrier in Hepatic Carcinoma Treatment: An in vitro Comparison Study

Biocompatibility and Effectiveness Evaluation of a New Hemostatic Embolization Agent: Thrombin Loaded Alginate Calcium Microsphere

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