Final Report of the Safety Assessment of Hyaluronic Acid, Potassium Hyaluronate, and Sodium Hyaluronate

Becker, Lillian C.; Bergfeld, Wilma F.; Belsito, Donald V.; Klaassen, Curtis D.; Marks, James G.; Shank, Ronald C.; Slaga, Thomas J.; Snyder, Paul W.; Andersen, F. Alan

doi:10.1177/1091581809337738

Cited by 100 publications

(58 citation statements)

References 209 publications

(234 reference statements)

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“…HA, a naturally derived polysaccharide, has demonstrated excellent biocompatibility and low cytotoxicity in various studies and applications [15]. One proposed method of HA application is either as a spray coating [16] or as an irrigation solution [17].…”

Section: Introductionmentioning

confidence: 99%

Cross-Linked Hyaluronic Acid Films to Reduce Intra-Abdominal Postsurgical Adhesions in an Experimental Model

Falabella

Chen²

2009

Dig Surg

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Background/Aims: Intra-abdominal adhesions typically occur after surgically damaged tissues are situated in apposition, leading to fibrotic connections. The goal of this study was to demonstrate the in vivo efficacy of a cross-linked and insoluble hyaluronic acid (HA) film to reduce postsurgical adhesion in a rat model. Methods: To measure in vitro adhesion resistance, porcine monocytes were deposited on the surface of films and their attachment was monitored by scanning electron microscopy. A rat cecum abrasion and abdominal insult model was utilized to demonstrate in vivo efficacy. Briefly, an HA film was deployed as a barrier between the damaged cecal and abdominal tissue surfaces for 21 days; control animals did not receive treatment. At the study conclusion, the rats were sacrificed and the degree of adhesion was determined using a scale from 0 to 3, where 0 = no adhesion and 3 = severe fibrosis. Results: HA films resisted monocyte adhesion in vitro. The in vivo study results demonstrated a significantly lower mean adhesion score (0.625 ± 0.517) with HA film treatment compared to the controls (2.09 ± 1.22). Conclusion: Placement of HA films between injured tissues significantly decreases the severity of abdominal adhesions. Furthermore, the HA film’s resistance to monocyte adhesion could be contributory to lowering in vivo adhesion scores.

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“…HA is known as a biocompatible polymer and studies have shown that it is safe for concentrations up to 1-2% (W/V) [17,18]. Comparing the results obtained for the HA and HASSNH 2 polymers, no statistical differences were observed in all four tested situations.…”

Section: Polymer Modification Did Not Affect Cytotoxicitymentioning

confidence: 78%

Evaluation of cystamine-modified hyaluronic acid/chitosan polyplex as retinal gene vector

Oliveira

Marcelo

Costa

et al. 2016

Materials Science and Engineering: C

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Purpose: A successful gene therapy approach can prevent or treat congenital and acquired diseases. However, there is still no ideal non-viral vector for gene delivery in a safe and timely manner. In this report the anionic polymer hyaluronic acid (HA) was investigated as a potential vector for gene therapy. Due to its intrinsic characteristics it constitutes an excellent candidate to deliver therapeutic genes, pending the modification of its surface charge. Methods: To modify its charge, HA was modified with cystamine. Several formulations were prepared using modified HA combined with sodium sulfate, sodium triphosphate, K-carrageenan and chitosan. Vectors were characterized with respect to size, charge, DNA load and its protection, and effect on cell viability. The better performing formulations were further evaluated in vitro for their transfection efficiency in HEK293T and ARPE-19 cells. Results: Cell viability assays showed low cytotoxicity for both polymers. Gene transfer efficiency depended on cell line and formulation, but no increased transfection efficiency was observed with the modified polymer. Conclusions: HA has great potential as a gene therapy vector, but further optimization, including incorporation of a higher percentage of positive groups in HA, is needed before its use as a gene delivery vector.

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“…Les réactions inflammatoires locales immé-diates et non allergiques (érythème, tuméfaction) sont fré-quentes (8 % des cas) : elles disparaissent sans traitement [2]. Les réactions d'hypersensibilité aiguës et graves (anaphylaxie, urticaire, angioedème) sont rares (0,6 % des cas) [6,16,17].…”

Section: Discussionunclassified

Complication après injection d’acide hyaluronique : présentation d’un cas

d’Elbée¹,

Fricain²

2013

Med Buccale Chir Buccale

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Résumé -Les produits de comblement à base d'acide hyaluronique (AH) constituent une référence dans la correction et l'augmentation de volume des tissus mous faciaux. Ils ont une longue durée d'action, sont peu immunogènes et peuvent être éliminés par injection locale de hyaluronidase. Ces avantages expliquent leur utilisation fréquente. Des complications aiguës ou chroniques, mineures ou sévères, peuvent survenir après leur injection, même réalisée par un praticien expérimenté. Le cas d'une patiente ayant souffert de complications infectieuses et inflammatoires chroniques après injection d'acide hyaluronique est rapporté. Abstract -Complication following the injection of hyaluronic acid: a case report. Hyaluronic acid (HA) fillershave become the material of choice for soft-tissue augmentation of the face. They are longer lasting, less immunogenic and can be broken down by hyaluronidase. These advantages make HA fillers the most common of the temporary fillers on the market. However, early and delayed complications, ranging from minor to severe, can occur following HA-filler injection even if administered by an experienced practictioner. The case of a patient who suffered from chronic infectious and inflammatory complications following the injection of hyaluronic acid is reported.

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“…Globulki dopochwowe HydroVag ® pozbawione są miejscowego działania drażniącego na nabłonek pochwowy [15]. Wyniki badań nad tym produktem potwierdzają zatem opublikowane dotychczas dane wskazujące na brak działania drażniącego i alergizującego kwasu hialuronowego oraz jego soli [2].…”

Section: Profil Tolerancji Produktu Hydrovagunclassified

Stanowisko Zespołu Ekspertów Polskiego Towarzystwa Menopauzy i Andropauzy na temat zastosowania wyrobu medycznego HydroVag® w leczeniu zmian atroficznych pochwy

Dębski¹,

Paszkowski²,

Pertyński³

et al. 2013

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“…Disaccharide units are formed at the plasma membrane in vertebrates and some bacteria [48,49]. HA is characterised by a very large number of disaccharide pairs (10,000 or more), so its molecular mass is approximately 4 million Da [50]. HA was discovered in bovine vitreous humour by Meyer and Palmer in 1934.…”

Section: Hyaluronic Acidmentioning

confidence: 99%

The Role of Pharmacological Agents in Nerve Regeneration after Peripheral Nerve Repair

Mekaj¹

2017

Peripheral Nerve Regeneration - From Surgery to New Therapeutic Approaches Including Biomaterials and Cell-Based Therapies Deve

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Peripheral nerve injuries are frequent and represent a significant pathology of the peripheral nervous system because, despite operative techniques and successful microsurgical repair, in most cases, the nerve repair is followed by scar formation. Numerous investigations have been carried out with the aim of finding pharmacological substances that can prevent scar formation and speed up the regeneration of repaired nerves. This chapter is dedicated to the efforts of many researchers to find different pharmacological agents with local effects on the improvement of nerve regeneration. Numerous experiments have been carried out in mice and rabbits using hyaluronic acid, tacrolimus, cyclosporin A, melatonin, vitamin B12, methylprednisolone, riluzole and potassium and calcium channel blockers. In the experimental animal studies, topical pharmacological agents were used at the site of peripheral nerve repair. The effect of these substances is most commonly studied in sciatic nerve injury in experimental animals. Their effects were evaluated using a variety of methods, such as morphological, biomechanical, electrophysiological and functional evaluation, and the above-mentioned substances, have been shown to have neuroprotective and neuroregenerative properties though different mechanisms.

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Final Report of the Safety Assessment of Hyaluronic Acid, Potassium Hyaluronate, and Sodium Hyaluronate

Cited by 100 publications

References 209 publications

Cross-Linked Hyaluronic Acid Films to Reduce Intra-Abdominal Postsurgical Adhesions in an Experimental Model

Evaluation of cystamine-modified hyaluronic acid/chitosan polyplex as retinal gene vector

Complication après injection d’acide hyaluronique : présentation d’un cas

Stanowisko Zespołu Ekspertów Polskiego Towarzystwa Menopauzy i Andropauzy na temat zastosowania wyrobu medycznego HydroVag® w leczeniu zmian atroficznych pochwy

The Role of Pharmacological Agents in Nerve Regeneration after Peripheral Nerve Repair

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