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Abano Terme, Italy

Alessandrini A.,Foundation Medicine | Alessandrini A.,Private Practice | Fino P.,University of Rome La Sapienza | Giordan N.,Fidia Farmaceutici | And 2 more authors.
Journal of Cosmetic and Laser Therapy | Year: 2015

Objectives: The present study aimed to evaluate the effectiveness and safety of hyaluronic acid gel for the treatment of volume loss or contour deficiency. Methods: This 6-month, open-label study recruited sixty adults aged 40-65 years with bilateral moderate to severe volume loss or contour deficiency (Facial Volume Loss Scale [FVLS] score: 2-5). Eligible subjects were treated at the baseline visit with an injection of hyaluronic acid gel in one or more of three facial subregions: the zygomatic malar region, the anteromedial cheek and nasolabial folds. Results: A significant improvement from baseline was observed in the FVLS score at each study visit up to 6 months post treatment (p < 0.0125 by Wilcoxon test). A significant improvement was also observed in the Global Aesthetic Improvement Scale (GAIS) at each visit up to 6 months. The study showed that the GAIS score improved in 100% of subjects at month 3, while at the end of the study (month 6) the percentage of improved subjects decreased to 91. Treatment effect was maintained by 100% of subjects up to month 3, while 57% of subjects showed a persistence of effect up to month 6. Conclusions: Volume loss or contour deficiency may be safely and effectively corrected using the new dermal filler. © 2015 © 2015 Taylor & Francis Group, LLC. Source


Brun P.,University of Padua | Zavan B.,University of Padua | Vindigni V.,University of Padua | Schiavinato A.,Fidia Farmaceutici | And 3 more authors.
Journal of Biomedical Materials Research - Part B Applied Biomaterials | Year: 2012

The aim of this study was to compare the effects of native hyaluronan (HA) with that of its hexadecylamide derivative (HYADD) on proliferation of fibroblast-like synoviocytes (FLS) and chondrocytes. The production of inflammatory and anti-inflammatory cytokines was also analyzed in FLS cultures. The proliferation of osteoarthritis (OA) chondrocytes was enhanced when cells were treated with 0.5-1.5 mg mL -1 of HA or HYADD®4-G. This effect was completely suppressed by the anti-CD44 antibody. At 0.5 to 1 mg mL -1, HA and HYADD®4-G did not influence the proliferation of normal or pathological FLS; however, at the higher concentration (1.5 mg mL -1), HYADD®4-G did significantly inhibit cell proliferation. As to effects on inflammation, a significant increase in the expression of the IL-10 gene was observed when FLS were pretreated with tumor necrosis factor alpha and then cultured in the presence of 0.5 mg mL -1 HYADD® 4-G or HA. The effects of HA derivatives on FLS proliferation and production of anti-inflammatory cytokines indicate that they may be of therapeutic benefit in OA. The longer residence time in the joint cavity, the increased viscoelasticity, and the anti-inflammatory potential of HYADD®4-G make it a better candidate than native HA for OA therapy. © 2012 Wiley Periodicals, Inc. Source


Schiavinato A.,Fidia Farmaceutici | Whiteside R.A.,University of Guelph
Clinical Biomechanics | Year: 2012

Background: Intra-articular injection of hyaluronic acid based therapies is gaining popularity as a treatment option for non-operative management of patients with symptomatic osteoarthritis. Although there is an abundance of evidence for both biological and mechanical mechanisms of joint protection by hyaluronic acid, one clear intention of viscosupplementation is to reduce friction and wear by providing an extrinsic lubricant. We tested the in vitro friction response of a novel hyaluronic acid derivative that presents amphiphilic features to promote adhesion to the cartilage surface and thereby improve cartilage lubrication. Methods: Migrating Contact Area and Static Contact Area friction tests were conducted on bovine articular cartilage to assess the efficacy of two lubricants, a chemically modified amphiphilic hyaluronic acid and synovial fluid from a healthy joint, as well as a phosphate buffered saline negative control. Findings: No differences in lubrication (P = 0.34) were evident between the three test articles during the Migrating Contact Area test, which represents articulation of healthy articular cartilage. The modified hyaluronic acid presented an equilibrium friction coefficient 2.8 times less than that of the synovial fluid (P ≤ 0.0005) and five times less than that of the PBS control (P ≤ 0.0001) during the Static Contact Area test, representing a mixed lubrication condition. Interpretation: The present study demonstrated that a chemically modified amphiphilic hyaluronic acid can provide equivalent lubrication to synovial fluid during articulation of loaded healthy articular cartilage and can provide superior lubrication as indicated by a lower coefficient of friction than synovial fluid under loading conditions potentially associated with cartilage wear. © 2011 Elsevier Ltd. All rights reserved. Source


Mero A.,University of Padua | Campisi M.,Fidia Farmaceutici | Caputo M.,Local Unit Fidia Research Sud | Cuppari C.,Local Unit Fidia Research Sud | And 5 more authors.
Current Drug Targets | Year: 2015

Hyaluronic acid (HA) is a natural polysaccharide primarily present in the vitreous humor and in cartilages where it plays a key structural role in organizing the cartilage extracellular matrix. HA is used in a wide range of applications including treatment of arthritis (as a viscosupplementation agent for joints) and in a variety of cosmetic injectable products. Its safety profile is thus well established. Thanks to its high biocompatibility and targeting properties, HA has also been investigated for use as a carrier of anticancer drugs and, recently, also of proteins. Its role in the last case is a particularly challenging one as dedicated coupling chemistries are required to preserve the protein’s conformation and activity. This study focuses on the state of the art on protein HAylation. New data from our laboratory on the local delivery of specific biologics to joints will also be outlined. © 2015 Bentham Science Publishers. Source


Mero A.,University of Padua | Campisi M.,Fidia Farmaceutici | Favero M.,University of Padua | Barbera C.,Fidia Farmaceutici | And 6 more authors.
Journal of Controlled Release | Year: 2014

Osteoarthritis (OA) is characterized by chronic degeneration of joints, involving mainly the articular cartilage and the underlying bone, and severely impairing the quality of life of the patient. Although with limited efficacy, currently available pharmacological treatments for OA aim to control pain and to retard disease progression. Salmon calcitonin (sCT) is a drug which has been shown to have therapeutic effects in experimental arthritis by inhibiting both bone turnover and cartilage degradation and reducing the activities of matrix metalloproteinases (MMP). High molecular weight hyaluronic acid (HA) is used as a lubricant in OA therapy, and, interestingly, HA polymers may normalize the levels of MMP-1, -3 and -13. We demonstrated that sCT rapidly clears from the knee joint of rat animal model, after intra-articular (i.a.) administration, and it induces systemic effects. Here, sCT was conjugated to HA (200 kDa) with the aim of prolonging the residence time of the polypeptide in the joint space by reducing its clearance. An aldehyde derivative of HA was used for N-terminal site-selective coupling of sCT. The activity of sCT was preserved, both in vitro and in vivo, after its conjugation and the i.a. injection of HA-sCT did not trigger any systemic effects in rats. The efficacy of HA-sCT treatment was tested in a rabbit OA model and clear chondro-protective effect was proven by macro- and microscopic assessments and histological findings. Our results indicate that HAylation of sCT increases the size of the polypeptide in a stable covalent manner and delays its passage into the blood stream. We conclude that HA conjugation prolongs the anti-catabolic effects of sCT in joint tissues, including the synovial membrane and cartilage. © 2014 Elsevier B.V. Source

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