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2. An Overview of Soft Tissue Fillers for Cosmetic Dermatology: From Filling to Regenerative Medicine

Author

Cassuto D, Bellia G, and Schiraldi C

Subjects
hyaluronic acid, filler, hydrogel, crosslinking, Dermatology, RL1-803
Abstract

Daniel Cassuto,1,2 Gilberto Bellia,3 Chiara Schiraldi4 1Private Practice, Tel Aviv, Israel; 2Private Practice, Milan, Italy; 3IBSA Farmaceutici Italia Srl, Lodi, Italy; 4Department of Experimental Medicine, School of Medicine, University of Campania “Luigi Vanvitelli”, Naples, ItalyCorrespondence: Daniel Cassuto Email daniel.cassuto@gmail.comAbstract: Hyaluronic acid (HA)-based injectable filling agents are at the forefront of the current demand for noninvasive dermatological procedures for the correction of age-related soft tissue defects. The present review aims to summarize currently available HA-based products and critically appraise their differences in rheological nature and clinical application. Linear HA (LHA) gels may be supplemented with amino acids, lipoic acid, vitamins, nucleosides, or minerals for synergistic antiaging and antioxidant benefits (polycomponent LHA). HA hydrogels can be generated via chemical or physical crosslinking, which increases their elasticity and decreases viscosity. The performance of crosslinked fillers depends on HA concentration, degree of crosslinking, elastic modulus, cohesivity, and type of crosslinking agent employed. PEG-crosslinked LHA displays improved elasticity and resistance to degradation, and lower swelling rates as compared to BDDE-crosslinked LHA. Physical crosslinking stabilizes HA hydrogels without employing exogenous chemical compounds or altering hyaluronans’ natural molecular structure. Thermally stabilized hybrid cooperative HA complexes (HCC) are a formulation of high- and low-molecular-weight (H-HA and L-HA) hyaluronans, achieving high HA concentration, low viscosity with optimal tissue diffusion, and a duration comparable to weakly cross-linked gel. Our critical analysis evidences the importance of understanding different fillers’ properties to assist physicians in selecting the most appropriate filler for specific uses and for predictable and sustainable results.Keywords: hyaluronic acid, filler, hydrogel, crosslinking

Published
2021

4. Evaluation of the Volumizing Performance of a New Volumizer Filler in Volunteers with Age-Related Midfacial Volume Defects

Author

Sparavigna A, La Gatta A, Bellia G, La Penna L, Giori AM, Vecchi G, Tenconi B, and Schiraldi C

Subjects
midfacial aging, crosslinked hyaluronic acid, clinical assessment, instrumental assessment., Dermatology, RL1-803
Abstract

Adele Sparavigna,1 Annalisa La Gatta,2 Gilberto Bellia,3 Laura La Penna,1 Andrea Maria Giori,4 Gabriele Vecchi,4 Beatrice Tenconi,1 Chiara Schiraldi2 1DERMING Srl., Milan, Italy; 2Department of Experimental Medicine, Section of Biotechnology, Medical Histology and Molecular Biology, School of Medicine, University of Campania “L. Vanvitelli”, Naples, Italy; 3Medical Affairs, IBSA Farmaceutici Italia, Lodi, Italy; 4Research and Development, IBSA Farmaceutici Italia, Lodi, ItalyCorrespondence: Adele SparavignaDERMING Srl, Clinical Research and Bioengineering Institute, Via Valassina, 24, Milano, ItalyTel +39 2 2318 3475Email adele.sparavigna@derming.comPurpose: The primary aim of this study was to evaluate the performance of the study product, in terms of volumizing activity as well as the duration of the effect, in women with age-related midfacial volume defects. In addition, the study allowed the evaluation of the tolerability of the product by both volunteers and investigators.Patients and Methods: Twenty-two female volunteers, aged 42– 60 years, participated in this study, which was performed under dermatological control in a single center. After an initial visit at baseline to verify adherence to the protocol criteria, volunteers received an injection of Aliaxin® SV (IBSA Farmaceutici Italia Srl), followed 3– 4 weeks later by a second touch-up treatment to treat eventual asymmetries. Four subsequent visits, the last performed 9 months from the first injection, were performed to evaluate clinically and instrumentally the efficacy of the treatment.Results: Clinical and statistically significant improvement in cheek volume was recorded after the first postinjection visit, and the effect was maintained until the end of the study period. A clinically measurable amelioration of wrinkle severity was also observed. By 3D picture recording and subsequent quantitative analysis, it was possible to determine the efficacy in terms of increased facial volume, which was already appreciable at the first visit, was further increased at the second and third visits and was maintained at the fourth and last visits. The injections were very well tolerated by the volunteers, as determined by their self-evaluation questionnaires.Conclusion: The results of the study confirm the esthetic performance of the study product on age-related midfacial volume defects. The very strong high-volumizing activity of the study product was not only properly determined by the investigators but also confirmed by self-evaluation by the volunteers. These effects were obtained with no appreciable undesired effects.Keywords: midfacial aging, crosslinked hyaluronic acid, clinical assessment, instrumental assessment

Published
2020

5. Hyaluronan Dermal Fillers: Efforts Towards a Wider Biophysical Characterization and the Correlation of the Biophysical Parameters to the Clinical Outcome

Author

La Gatta A, Schiraldi C, Zaccaria G, and Cassuto D

Subjects
dermal filler, degradation, cohesivity, palpability, Dermatology, RL1-803
Abstract

Annalisa La Gatta,1 Chiara Schiraldi,1 Giovanna Zaccaria,2 Daniel Cassuto2 1Department Experimental Medicine, Section of Biotechnology, Medical Histology and Molecular Biology, School of Medicine, University of Campania “L. Vanvitelli”, Naples 80138, Italy; 2Private Practice, Milan, ItalyCorrespondence: Chiara Schiraldi via De Crecchio 7, Naples 80138, ItalyTel +39 081 5667546Fax +39 081 5665897Email chiara.schiraldi@unicampania.itDaniel Cassuto Dr. Daniel Cassuto, Piazza V Giornate 1, Milan 20129, ItalyTel +39 02 36723960Email daniel.cassuto@gmail.comIntroduction: Hyaluronic Acid (HA) fillers are among the most used products in cosmetic medicine. Companies offer different formulations to allow full facial treatment and/or remodeling. Gels are being studied to establish the biophysical properties behind the specific clinical use and a correlation between the gel biophysical properties and their clinical performance. Clinicians’ awareness is growing about the potential benefit deriving from such biophysical characterization.Aim: The Aliaxin® line of HA dermal fillers is the object of this study. The study aimed to widen the biophysical characterization of these gels by investigating a variety of properties to better support their optimal use. Further, we aimed to provide some clinical findings to gain a deeper insight into the correlation between filler features and clinical outcome.Methods: The four gels of the line were investigated, for the first time, for their cohesivity and stability to Reactive Oxygen Species (ROS). Additional secondary rheological parameters; evidence of relative water-uptake ability; and some clinical findings on product safety, palpability and duration of the aesthetic effect are provided.Results and conclusion: The gels proved highly cohesive and sensitive to ROS action with stability declining with the decrease in the overall gel elasticity. The G* and complex viscosity values at clinically relevant frequencies and gel water-uptake ability are consistent with the relative clinical indication related to gel projection and hydration capacity. Clinical outcomes showed the safety of the products and a perception of palpability well correlating with the cohesive/viscosity properties of the gels. A similar duration of the aesthetic effect (up to 1 year) was observed despite the diverse in vitro gel stability. The results broaden our knowledge of these gels and may contribute to optimize their clinical use towards the improvement of patient safety and satisfaction. Initial clinical observation indicated that gel biophysical properties allow for a reliable prediction of gel palpability, while in vitro data on gel stability cannot be related to the duration of the observed skin improvement. The latter finding further corroborates the idea of a skin restoration process activated by the gels besides the physical volumetric action.Keywords: dermal filler, degradation, cohesivity, palpability

Published
2020

9. Erratum: Novel Hybrid Gels Made of High and Low Molecular Weight Hyaluronic Acid Induce Proliferation and Reduce Inflammation in an Osteoarthritis in Vitro Model Based on Human Synoviocytes and Chondrocytes (BioMed Research International (2019) 2019 (4328219) DOI: 10.1155/2019/4328219)

Author

Stellavato A., Vassallo V., La Gatta A., Pirozzi A. V. A., De Rosa M., Balato G., D'addona A., Tirino V., Ruosi C., Schiraldi C., Stellavato, A., Vassallo, V., La Gatta, A., Pirozzi, A. V. A., De Rosa, M., Balato, G., D'Addona, A., Tirino, V., Ruosi, C., and Schiraldi, C.

Abstract

In the article titled "Novel Hybrid Gels Made of High and Low Molecular Weight Hyaluronic Acid Induce Proliferation and Reduce Inflammation in an Osteoarthritis In Vitro Model Based on Human Synoviocytes and Chondrocytes" [1], there was an error in Figure 6. In the part of Figure 6(a), "HCC 24h" is incorrect. The corrected figure is shown below, and is listed as (Figure present).

Published
2020

19. Hybrid complexes of high and low molecular weight hyaluronan delay in vitro replicative senescence of mesenchymal stromal cells: a pilot study for future therapeutic application

Author

Alessio N, Stellavato A, Squillaro T, Del Gaudio S, Di Bernardo G, Peluso G, De Rosa M, Schiraldi C, and Galderisi U.

Subjects
extracellular matrix, hyaluronan, mesenchymal stromal cells, senescence
Abstract

Mesenchymal stem cells, a subpopulation of mesenchymal stromal cells (MSCs), are present in the stroma of several tissues. MSC in vitro cultivation for clinical treatments may greatly affect MSC properties. A primary handicap is replicative senescence that impairs MSC functions. Hyaluronan (HA) is present in the extracellular matrix that composes the stem cell niche environment and is under investigation as a key factor for in vitro stem cell growth. We evaluated the effect on MSC cultivation of HA hybrid cooperative complexes (HCC) that are obtained from high (H) and low (L) weight molecules (NAHYCO(TM)). We compared this HCC with H-HA and L-HA. We investigated the effects of these HAs on proliferation, cell cycle, apoptosis, senescence, and differentiation following the addition of the polymer solutions in the culture media at concentrations that did not drastically modify the medium viscosity. Interestingly, 0,16% HCC significantly delayed the senescence compared with the controls. This occurred without alteration of the cell cycle, cytotoxicity, or apoptosis. HCCs also promoted adipogenic and chondrogenic differentiation. Our finding could suggest a potential functional role of HCC above the updated scientific reports of its effects and pave the way to optimization of MSC cultivation for therapeutic application.

Published
2018

25. Production and purification of higher molecular weight chondroitin by metabolically engineered Escherichia coli K4 strains.

Author

D'ambrosio, S., Alfano, A., Cassese, E., Restaino, O. F., Barbuto Ferraiuolo, S., Finamore, R., Cammarota, M., Schiraldi, C., and Cimini, D.

Subjects
CHONDROITIN, CARTILAGE, POLYSACCHARIDES, ESCHERICHIA coli, GLYCOSAMINOGLYCANS
Abstract

The capsular polysaccharide obtained from Escherichia coli K4 is a glycosaminoglycan-like molecule, similar to chondroitin sulphate, that has established applications in the biomedical field. Recent efforts focused on the development of strategies to increase K4 polysaccharide fermentation titers up to technologically attractive levels, but an aspect that has not been investigated so far, is how changes in the molecular machinery that produces this biopolymer affect its molecular weight. In this work, we took advantage of recombinant E. coli K4 strains that overproduce capsular polysaccharide, to study whether the inferred pathway modifications also influenced the size of the produced polymer. Fed-batch fermentations were performed up to the 22 L scale, in potentially industrially applicable conditions, and a purification protocol that allows in particular the recovery of high molecular weight unsulphated chondroitin, was developed next. This approach allowed to determine the molecular weight of the purified polysaccharide, demonstrating that kfoF overexpression increased polymer size up to 133 kDa. Higher polysaccharide titers and size were also correlated to increased concentrations of UDP-GlcA and decreased concentrations of UDP-GalNAc during growth. These results are interesting also in view of novel potential applications of higher molecular weight chondroitin and chondroitin sulphate in the biomedical field. [ABSTRACT FROM AUTHOR]

Published
2020
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27. Physico-optical properties of a crosslinked hyaluronic acid scaffold for biomedical applications

Author

Lepore, M, Portaccio, M, Delfino, I, Sironi, L, La Gatta, A, D'Agostino, A, Izzo, E, Schiraldi, C, Lepore, Maria, Portaccio, Marianna, Delfino, Ines, Sironi, Laura, La Gatta, Annalisa, D'Agostino, Antonella, Izzo, E., Schiraldi, Chiara, Lepore, M, Portaccio, M, Delfino, I, Sironi, L, La Gatta, A, D'Agostino, A, Izzo, E, Schiraldi, C, Lepore, Maria, Portaccio, Marianna, Delfino, Ines, Sironi, Laura, La Gatta, Annalisa, D'Agostino, Antonella, Izzo, E., and Schiraldi, Chiara

Abstract

Optical techniques are increasingly employed for monitoring cell-matrix interactions in suitably prepared 3D scaffolds. The ability of designing and realizing synthetic extracellular matrix with well-controlled optical properties is a crucial need in this field. For this purpose, a crosslinked hyaluronic acid (HA) scaffold is prepared. Fourier transform infrared and ultraviolet-visible spectroscopies enable to monitor the scaffold preparation process and to evidence scaffold high transparency and low fluorescence in the visible range. 3D optical characteristics of the HA scaffold are tested by two-photon microscopy (TPM) imaging of embedded fluorescent microbeads and alive keratinocytes labeled with vital PKH67 dye at different depths from the scaffold surface. Some useful indications about the potentiality of TPM measurements for the determination of attenuation coefficient of turbid media are also reported. Moreover, the use of the presented HA scaffold for preparing tissue phantoms for fluorescence imaging or diffuse imaging is proposed

Published
2017

28. Hyaluronan viscosupplementation: state of the art and insight into the novel cooperative hybrid complexes based on high and low molecular weight HA of potential interest in osteoarthritis treatment

Author

Stellavato A, La Gatta A, Schiraldi C, De Rosa M, de Novellis F, Schiraldi, Chiara, Stellavato, Antonietta, de Novellis, F, LA GATTA, Annalisa, and De Rosa, M.

Subjects
0301 basic medicine, medicine.medical_specialty, business.industry, Materials Science (miscellaneous), Inflammation, Osteoarthritis, Mini-Review, Pharmacology, medicine.disease, In vitro, Proinflammatory cytokine, Glycosaminoglycan, 03 medical and health sciences, 030104 developmental biology, Maintenance therapy, Synovitis, Physical therapy, Medicine, Viscosupplementation, medicine.symptom, business
Abstract

Osteoarthritis (OA) represents a group of chronic, painful, disabling conditions affecting synovial joints. It is characterized by degeneration of articular cartilage, alterations of peri-articular and subchondral bone, low-grade synovial inflammation (synovitis). Despite OA is commonly described as a non-inflammatory disease, it is known that its progression and the subsequent increment of symptoms correlate to the production of inflammatory factors that induce the secretion of enzymes responsible for cartilage degradation. In clinical practice, to alleviate pain and stiffness, not only during acute phases but also as maintenance therapy, intra-articular injections of corticosteroids or similar drugs are used, besides it is well diffused the viscosupplementation procedure based on hyaluronan gel. There are many different products containing high molecular weight linear HA or cross-linked derivatives, however the novelty in the field consist in the hybrid cooperative complexes derived from high and low molecular weight HA through a patented processing. This technique permit to double the amount of HA delivered to the injured site without increasing the injected volume, beside in vitro assay on human chondrocytes suggested hybrid complexes as effective in the modulation of several inflammatory cytokines in joints.

Published
2016

29. Design of inhibitors of influenza virus membrane fusion: Synthesis, structure-activity relationship and in vitro antiviral activity of a novel indole series

Author

Brancato, V, Peduto, A, Wharton, S, Martin, S, More, V, Di Mola, A, Massa, A, Perfetto, B, Donnarumma, G, Schiraldi, C, Tufano, M, de Rosa, M, Filosa, R, Hay, A, Brancato V., Peduto A., Wharton S., Martin S., More V., Di Mola A., Massa A., Perfetto B., Donnarumma G., Schiraldi C., Tufano M. A., de Rosa M., Filosa R., Hay A., Brancato, V, Peduto, A, Wharton, S, Martin, S, More, V, Di Mola, A, Massa, A, Perfetto, B, Donnarumma, G, Schiraldi, C, Tufano, M, de Rosa, M, Filosa, R, Hay, A, Brancato V., Peduto A., Wharton S., Martin S., More V., Di Mola A., Massa A., Perfetto B., Donnarumma G., Schiraldi C., Tufano M. A., de Rosa M., Filosa R., and Hay A.

Abstract

The fusion of virus and endosome membranes is an essential early stage in influenza virus infection. The low pH-induced conformational change which promotes the fusogenic activity of the haemagglutinin (HA) is thus an attractive target as an antiviral strategy. The anti-influenza drug Arbidol is representative of a class of antivirals which inhibits HA-mediated membrane fusion by increasing the acid stability of the HA. In this study two series of indole derivatives structurally related to Arbidol were designed and synthesized to further probe the foundation of its antiviral activity and develop the basis for a structure-activity relationship (SAR). Ethyl 5-(hydroxymethyl)-1-methyl-2-(phenysulphanylmethyl)-1. H-indole-3-carboxylate (15) was identified as one of the most potent inhibitors and more potent than Arbidol against certain subtypes of influenza A viruses. In particular, 15 exhibited a much greater affinity and preference for binding group 2 than group 1 HAs, and exerted a greater stabilising effect, in contrast to Arbidol. The results provide the basis for more detailed SAR studies of Arbidol binding to HA; however, the greater affinity for binding HA was not reflected in a comparable increase in antiviral activity of 15, apparently reflecting the complex nature of the antiviral activity of Arbidol and its derivatives.

Published
2013

31. Production of human pro-relaxin H2 in the yeast Pichia pastoris

Author

Cimini, D., primary, Corte, K. Della, additional, Finamore, R., additional, Andreozzi, L., additional, Stellavato, A., additional, Pirozzi, A. V. A., additional, Ferrara, F., additional, Formisano, R., additional, De Rosa, M., additional, Chino, M., additional, Lista, L., additional, Lombardi, A., additional, Pavone, V., additional, and Schiraldi, C., additional

Published
2017
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33. Osteoporosis Risk in Patients With Chronic Obstructive Pulmonary Disease: The EOLO Study

Author

Maggi, S, Siviero, P, Gonnelli, S, Schiraldi, C, Malavolta, N, Nuti, R, Crepaldi, G, Paggiaro, PIER LUIGI, EOLO Study Group, Maggi, S, Siviero, P, Gonnelli, S, Schiraldi, C, Malavolta, N, Nuti, R, Crepaldi, G, EOLO Study, Group, and DEL PUENTE, Antonio

Subjects
Spirometry, Male, medicine.medical_specialty, Chronic Obstructive, Multivariate analysis, Endocrinology, Diabetes and Metabolism, Osteoporosis, Disease, Logistic regression, Body Mass Index, Cohort Studies, Pulmonary Disease, Pulmonary Disease, Chronic Obstructive, quantitative ultrasound, Sex Factors, Endocrinology, Risk Factors, Internal medicine, Forced Expiratory Volume, Nuclear Medicine and Imaging, medicine, 80 and over, Prevalence, COPD, osteoporosis risk, Humans, Radiology, Nuclear Medicine and imaging, vertebral fractures, Orthopedics and Sports Medicine, Glucocorticoids, copd, risk factors, Aged, Aged, 80 and over, medicine.diagnostic_test, business.industry, Age Factors, Middle Aged, medicine.disease, Diabetes and Metabolism, Italy, Physical therapy, Female, business, Radiology, Body mass index, Radiology, Nuclear Medicine and Imaging, Cohort study
Abstract

Chronic obstructive pulmonary disease (COPD) appears to be associated with osteoporosis. The aim of the study was to evaluate the prevalence of osteoporosis risk (OP risk) in a sample of patients with COPD. In 3030 patients (1768 men and 1262 women) aged >50 yr, we evaluated COPD severity with spirometry and OP risk by using a quantitative ultrasound device. We analyzed several risk factors for osteoporosis, such as age, gender, body mass index (BMI), fracture history, smoking status, glucocorticoid (GC) treatment in univariate and in multinomial logistic regressions. The risk of osteoporosis was higher in women and in older participants, among those with more severe COPD, treated with GC. In multivariate analysis, we found interactions between fracture history and smoking and between age and gender. Significant associations were found with BMI and GC treatment, whereas only a tendency, not statistically significant, was found for very severe COPD being associated to high risk of osteoporosis. In COPD patients the risk of osteoporosis is high, in particular at severe stages of the disease, but seems to be due to traditional risk factors, such as older age, female gender, low BMI, history of smoking and fractures, GC treatment.

Published
2009

41. Properties of the recombinant alpha-glucosidase from Sulfolobus solfataricus in relation to starch processing. J. Mol Cat B: Enzymatic

Author

MARTINO A., SCHIRALDI C., FUSCO S., DI LERNIA I., COSTABILE T., PELLICANO T., MAROTTA M., GENEROSO M., VAN DER OOST J., SENSEN C. W., CHARLEBOIS R. L., MORACCI M., ROSSI M., DE ROSA, Mario, Martino, A., Schiraldi, C., Fusco, S., DI LERNIA, I., Costabile, T., Pellicano, T., Marotta, M., Generoso, M., VAN DER OOST, J., Sensen, C. W., Charlebois, R. L., Moracci, M., Rossi, M., and DE ROSA, Mario

Published
2001

42. Chimica e propedeutica biochimica

Author

Bono, A, Cammarota, M, Cimini, D, Coletta, M, D'Agostino, A, Damonte, G, De Rosa, M, Di Gaudio, F, Galliano, M, Giuliano, M, La Gatta, A, Marini, S, Meggio, F, Minchiotti, L, Restaino, O, Santucci, R, Schiraldi, C, and Spisni, A

Subjects
Settore BIO/10
Published
2012

44. Criteri di valutazione pneumologica per l'idoneità all'attività sportiva

Author

Brunese, F., Casali, L., Campigotto, F., Cogo, Annaluisa, Dal Negro, R., i. Di Napoli P. L., Ferrante, E., Fiorenzano, G., Liguori, P., Milanesem, Milani, G., Del Giudice, M. M., Pinchi, G., Santoriello, C., Satta, A., Schiraldi, C., Spinella, C., Tancredi, G., and Turchetta, A.

Subjects
valutazione pneumologica, l'idoneità sportiva
Published
2006

49. Fighting for territories: time-lapse analysis of dental pulp and dental follicle stem cells in co-culture reveals specific migratory capabilities

Author

Schiraldi, C, Stellavato, A, D'Agostino, A, Tirino, V, d'Aquino, R, Woloszyk, A, De Rosa, A, Laino, L, Papaccio, G, Mitsiadis, T A, Schiraldi, C, Stellavato, A, D'Agostino, A, Tirino, V, d'Aquino, R, Woloszyk, A, De Rosa, A, Laino, L, Papaccio, G, and Mitsiadis, T A

Abstract

Stem cell migration is a critical step during the repair of damaged tissues. In order to achieve appropriate cell-based therapies for tooth and periodontal ligament repair it is necessary first to understand the dynamics of tissue-specific stem cell populations such as dental pulp stem cells (DPSC) and dental follicle stem cells (DFSC). Using time-lapse imaging, we analysed migratory and proliferative capabilities of these two human stem cell lines in vitro. When cultured alone, both DPSC and DFSC exhibited low and irregular migration profiles. In co-cultures, DFSC, but not DPSC, spectacularly increased their migration activity and velocity. DFSC rapidly surrounded the DPSC, thus resembling the in vivo developmental process, where follicle cells encircle both dental epithelium and pulp. Cell morphology was dependent on the culture conditions (mono-culture or co-culture) and changed over time. Regulatory genes involved in dental cell migration and differentiation such as TWIST1, MSX1, RUNX2, SFRP1 and ADAM28, were also evaluated in co-cultures. MSX1 up-regulation indicates that DPSC and DFSC retain their odontogenic potential. However, DPSC lose their capacity to differentiate into odontoblasts in the presence of DFSC, as suggested by RUNX2 up-regulation and TWIST1 down-regulation. In contrast, the unchanged levels of SFRP1 expression suggest that DFSC retain their potential to form periodontal tissues even in the presence of DPSC. These findings demonstrate that stem cells behave differently according to their environment, retain their genetic memory, and compete with each other to acquire the appropriate territory. Understanding the mechanisms involved in stem cell migration may lead to new therapeutic approaches for tooth repair.

Published
2012

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