Polycaprolactone spheres and theromosensitive pluronic F127 hydrogel for vocal fold augmentation: In vivo animal study for the treatment of unilateral vocal fold palsy

Kwon, Seong Keun; Song, Jae Jun; Cho, Chang Gun; Park, Seok Won; Choi, Soo Jung; Oh, Se Heang; Lee, Jin Ho

doi:10.1002/lary.23879

Cited by 21 publications

(33 citation statements)

References 20 publications

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“…In a previous pilot study in animals, we demonstrated excellent tolerance of this bioimplant injected into the paralyzed vocal fold; no adverse reactions were observed over a 12-week follow-up period. [27] We performed the present long-term study to confirm the good results obtained in these first preclinical trials. Overall, a comparative analysis of the histological results over a period of 12 months indicated that in contrast to Radiesse®, PCL microspheres/Pluronic F127 remained more in volume at the paralyzed vocal fold, without inducing inflammation or migration.…”

Section: Discussionsupporting

confidence: 54%

Vocal Fold Augmentation with Injectable Polycaprolactone Microspheres/Pluronic F127 Hydrogel: Long-Term In Vivo Study for the Treatment of Glottal Insufficiency

et al. 2014

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There is increasing demand for reconstruction of glottal insufficiency. Several injection materials have been examined for this purpose, but all had limitations, such as poor long-term durability, migration from the injection site, inflammation, granuloma formation, and interference with vocal fold vibration due to viscoelastic mismatch. Here, we developed a novel injection material, consisting of polycaprolactone (PCL) microspheres, which exhibits better viscoelasticity than conventional materials, and Pluronic F127 carrier, which decreases the migration of the injection materials. The material was injected into rabbits with glottal insufficiency and compared with the FDA-approved injection material, calcium hydroxylapatite (CaHA). Endoscopic and histological examinations indicated that PCL/Pluronic F127 remained at the injection site with no inflammatory response or granuloma formation, whereas CaHA leaked out and migrated from the injection site. Therefore, vocal fold augmentation was almost completely retained during the 12-month follow-up period in this study. Moreover, induced phonation and high-speed recording of vocal fold vibration showed decreased vocal fold gap area in the PCL/Pluronic F127 group. Our newly developed injection material, PCL/Pluronic F127, permits efficient augmentation of paralyzed vocal fold without complications, a concept that can be applied clinically, as demonstrated by the successful long-term follow-up.

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Section: Discussionsupporting

confidence: 54%

Vocal Fold Augmentation with Injectable Polycaprolactone Microspheres/Pluronic F127 Hydrogel: Long-Term In Vivo Study for the Treatment of Glottal Insufficiency

et al. 2014

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“…Endoscopic and histological analysis showed that the PCL spheres/Pluronic F127 gel mixture exhibited excellent integration with the surrounding tissues, maintained the injected volume without migration or induction of inflammatory response, decreased the vocal gap, and improved asymmetric VF movement, suggesting its potential as a new therapeutic biomaterial to treat VF paralysis. [133] In parallel, the authors investigated the effects of another synthetic and biodegradable polymer poly(lactic-co-glycolic acid) (PLGA) with Pluronic F127 mixture for the augmentation of atrophied VFs. Laryngoscopic analysis showed that both 5wt% and 10wt% PLGA/Pluronic F127 gels maintained their integrity 8 weeks after injection without inducing significant inflammatory response.…”

Section: Biomaterials In Development/researchmentioning

confidence: 99%

Tissue engineering-based therapeutic strategies for vocal fold repair and regeneration

Stiadle

Lau

et al. 2016

Biomaterials

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Vocal folds are soft laryngeal connective tissues with distinct layered structures and complex multicomponent matrix compositions that endow phonatory and respiratory functions. This delicate tissue is easily damaged by various environmental factors and pathological conditions, altering vocal biomechanics and causing debilitating vocal disorders that detrimentally affect the daily lives of suffering individuals. Modern techniques and advanced knowledge of regenerative medicine have led to a deeper understanding of the microstructure, microphysiology, and micropathophysiology of vocal fold tissues. State-of-the-art materials ranging from extracecullar-matrix (ECM)-derived biomaterials to synthetic polymer scaffolds have been proposed for the prevention and treatment of voice disorders including vocal fold scarring and fibrosis. This review intends to provide a thorough overview of current achievements in the field of vocal fold tissue engineering, including the fabrication of injectable biomaterials to mimic in vitro cell microenvironments, novel designs of bioreactors that capture in vivo tissue biomechanics, and establishment of various animal models to characterize the in vivo biocompatibility of these materials. The combination of polymeric scaffolds, cell transplantation, biomechanical stimulation, and delivery of antifibrotic growth factors will lead to successful restoration of functional vocal folds and improved vocal recovery in animal models, facilitating the application of these materials and related methodologies in clinical practice.

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“…In 2013 and 2014, Kwon et al published short‐ and long‐term results of IL utilizing PCL microspheres. They were able to demonstrate excellent volume retention of material after 12 months and a small amount of inflammatory reaction to the injection in a rabbit model . Their study did not note any material migration over time in the PCL group.…”

Section: Discussionmentioning

confidence: 94%

“…Given these shortcomings, additional work to optimize injection material is warranted. Recent efforts to move toward a more ideal injectable have focused on either biological enhancement of traditional materials or use of long‐lasting synthetic biopolymers to enhance injection longevity . We hypothesized that we could create long‐lasting biomaterial using tissue‐engineering principles by utilizing a bioscaffold, a cell source, and growth factors (GFs) to create a novel, self‐sustaining biomaterial .…”

Section: Introductionmentioning

confidence: 99%

Preliminary results of tissue‐engineered injection laryngoplasty material in a rabbit model

et al. 2017

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Objectives/Hypothesis: Design and test a novel biomaterial for injection laryngoplasty aimed to increase the duration of effectiveness of micronized acellular dermis.Study Design: Animal model. Methods: Injection laryngoplasty was performed in three groups (n 5 5) of New Zealand White rabbits. Acellular dermis was either used alone as a control (group 1), was combined with undifferentiated stem cells (group 2), or with predifferentiated chondrocytic cells (group 3). Groups 2 and 3 were supplemented with growth factors. Animals were sacrificed 4 and 12 weeks after laryngoplasty and histologic analysis was completed. The major outcome measure was volume of tissue remaining.Results: After 4 weeks, the mean volume of tissue remaining was 341 6 89 mm 3 , 295 6 102 mm 3 , and 133 6 15 mm 3 , for groups 1 to 3, respectively. At the 12-week time point, volumes were 62 6 62 mm 3 , 235 6 35 mm 3 , and 107 6 99 mm 3 . After 12 weeks, there was a significantly higher volume in group 2 compared to group 1 or 3 (P 5 .01, P 5 .04). Volumes between week 4 and week 12 were significantly lower in group 1 (P 5 .02), but not significantly different for groups 2 and 3 (P 5 .38, P 5 .74). Histologic evaluation revealed a robust lymphocytic infiltration in all cases as well as morphologic and immunophenotypic features suggestive of chondrogenic differentiation in a single animal.Conclusions: Micronized acellular dermis combined with stem cells and growth factors showed significantly less resorption 12 weeks after injection laryngoplasty compared to micronized acellular dermis alone. Groups using novel tissue-engineered biomaterial showed a lower resorption rate over time compared with acellular dermis alone.

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Polycaprolactone spheres and theromosensitive pluronic F127 hydrogel for vocal fold augmentation: In vivo animal study for the treatment of unilateral vocal fold palsy

Abstract: Locally injected PCL/Pluronic F127 can enhance glottal contact, suggesting it as a potential new therapeutic approach that may lead to better treatment of vocal fold palsy.

Cited by 21 publications

References 20 publications

Vocal Fold Augmentation with Injectable Polycaprolactone Microspheres/Pluronic F127 Hydrogel: Long-Term In Vivo Study for the Treatment of Glottal Insufficiency

Vocal Fold Augmentation with Injectable Polycaprolactone Microspheres/Pluronic F127 Hydrogel: Long-Term In Vivo Study for the Treatment of Glottal Insufficiency

Tissue engineering-based therapeutic strategies for vocal fold repair and regeneration

Preliminary results of tissue‐engineered injection laryngoplasty material in a rabbit model

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