Hyaluronic Acid Gel Research Articles

Comparison of visibility of iodinated hydrogel and gadolinium-modified hyaluronic acid spacer gels on computed tomography and onboard imaging.

Background and purposeIn accelerated partial breast irradiation (APBI), accurate definition of the tumour bed is crucial to reduce the risk of local recurrence and the volume of healthy tissue irradiated. Recently, hydrogels have been proposed to improve visibility of the lumpectomy cavity for APBI. The aim of this study was to alter two commercially available hyaluronic acid (HA) gels, with gadopentenate dimeglumine (GD), a magnetic resonance imaging (MRI) contrast agent. We hypothesize that after injection in the surgical cavity, the mixtures will be visible with computed tomography (CT) for improved treatment planning, cone-beam CT (CBCT) for improved patient setup and planar kilovoltage (kV) x-ray for real-time tracking during treatment.Materials and methodsIn this ex vivo study, GD was mixed with the two HA gels, and 1 mL of each mixture was injected into fatty and muscular tissue of a pork phantom. Visibility with CT, CBCT and planar x-ray imaging was assessed. Contrast-to-noise ratios (CNR) were measured and compared to commercially available iodinated polyethylene glycol (PEG).ResultsThe gel mixtures showed increased visibility over HA gels without GD. When comparing CNR of the gel mixtures to that of iodinated PEG on CT, there was a 4-fold increase in muscle for both mixtures and a 1.6-fold to 3.6-fold increase in fat, depending on the HA gel. Gel mixtures showed better visibility with planar kV imaging over iodinated PEG.ConclusionAddition of GD to HA gels increases visibility with CT, CBCT and planar x-ray imaging, indicating potential for improved delineation and positioning in APBI.

Penile augmentation with injectable hyaluronic acid gel: an alternative choice for small penis syndrome.

There is no well-established procedure for the management of small penis syndrome (SPS), especially when psychological interventions fail. This study aimed at systematically evaluating the physical and psychological benefits of penile augmentation (PA) using injectable hyaluronic acid (HA) gel. Thirty-eight patients receiving PA with HA gel from January 2017 to March 2020 were included and followed up for 1 year. Penile size, erectile function, and psychological burden measured by the Index of Male Genital Image (IMGI), Index of International Erectile Function (IIEF), and Beliefs about Penis Size (BPAS), respectively, were assessed at the beginning and at 1, 3, 6, and 12 months postinjection. The volume of HA gel injected was 21.5 ± 3.7 ml. Compared to baseline data, flaccid penile girth and length significantly increased by 3.41 ± 0.95 cm (P < 0.01) and 2.55 ± 0.55 cm (P < 0.01) at the 1st month postinjection, respectively. At the endpoint, despite attenuations, statistically significant improvements in flaccid penis size were still obtained, namely 2.44 ± 1.14 cm in girth (P < 0.01) and 1.65 ± 0.59 cm in length (P < 0.01). Similarly, erectile penile girth statistically increased by 1.32 ± 1.02 cm (P < 0.01) at the 1st month but were only 0.80 ± 0.54 cm bigger than baseline (P < 0.01) at the endpoint. At the 1st month, the average score of IMGI and the mean score of IIEF statistically increased by 46.2 ± 10.5 (P < 0.01) and 7.6 ± 6.2 (P < 0.01), respectively; the score of BAPS significantly decreased by 18.3 ± 4.5 (P < 0.01). These alterations remained steady during follow-up. Considering the significant penile size improvement, lasting psychological benefit, and low complication rate, PA with HA might serve as an appropriate alternative for patients with SPS.

Stability of Two Cross-Linked Hyaluronic Acid Gels for the Treatment of Temporal Fossa Volume Loss: A Preliminary Study Using MRI and Visual Observations

Introduction: Hyaluronic Acid (HA) gels are a commonly used option for correcting facial volume loss. Over the past 2 years, we have been testing the clinical results of two HA gels, without lidocaine, made by the same manufacturer using the patented “Inter- Penetrating NetworkLike” (IPN-Like) cross-linking technology. The aim of this work was to evaluate if there is a difference in the tissue stability and associated clinical outcomes between these two gels. Material and methods: A 67 and 75 years old Caucasian women, from our private aesthetic center, agreed to be injected with the different HA volumiser gel, one in each of their temporal fossae. The Stylage® XL and XXL HA gels (LABORATOIRES VIVACY, Archamps, France) were used for this study. The gels have different concentrations and levels of cross-linking, but have the same indications for correcting facial volume loss resulting from the ageing process. Clinical outcomes included assessing the degree of pain experienced by participants during and after injection using a Visual Analog Scale (VAS). Aesthetic improvement was evaluated using the Merz Analogic Scale® (MAS)® and Global Aesthetic Improvement Scale (GAIS) scales completed by patients and independent experts at different pre-set time-points using photographs taken from the front, profile and three-quarter left and right angles. Moreover, Serial magnetic Resonance Imaging (MRI) scans were used to assess the tissue behavior of the gels immediately after injection and then 6 monthly for 2 years. Results: Both gels led to an improvement in the patients’ clinical outcomes. This improvement persisted over time. The MRI scans showed that, at Day 0, the injected gel was spherical in shape and became elongated by 6 months. This appearance did not change throughout the follow-up period. The scans showed little resorption at 24 months. Conclusion: Despite the relatively advanced age of the two patients and the small quantities of gel injected, the IPN-Like cross-linked hyaluronic acid volumiser gels had a satisfactory sustainable clinical effect as assessed by patients and experts. There was a slight advantage in favor of the gel with the lower HA concentration but higher level of cross-linking (Stylage® XXL). Given the observed persistent effect of the gels in our preliminary observation, it is now important to conduct a larger study with longer follow- up.

Effect of Adding Lidocaine to Hyaluronic Acid Gel for Volume Loss Correction: A Preliminary Observation

Introduction: Although adding a local anesthetic is an effective way to reduce pain during intradermal Hyaluronic Acid (HA) injections, it is not clear if the pain control is as effective when performing injections close to the bone. The primary aim of these preliminary observations was to explore this issue. As a secondary aim, we wanted to assess if the addition of lidocaine alters the behavior of HA gel in the tissues over time. Subjects: Two women provided informed written consent to participate in the study. Participants were blind to the type of HA gel used for either temporal fossa. Methods: A cross-linked HA gel was used for the study. One side was injected with the gel with and the other without lidocaine, in no particular order. Photographs from the front, profile and three-quarter left and right and frontal MRI scans were taken before and just after the injections, then every 6 months for 2 years. Results: The side injected with the gel with lidocaine was significantly less painful than that injected without lidocaine. Both types of gel changed shape on MRI in the first 6 months but stayed stable thereafter till the end of our follow-up at 24 months. Based on MRI, patient reported outcomes and expert assessed aesthetic outcomes, using MAS® and the global aesthetic improvement scale, both types of gel were comparable. Conclusion: The addition of lidocaine to HA volumiser gels reduces pain to a remarkable degree.

Local delivery of hyaluronic acid as an adjunct to scaling and root planing in the treatment of chronic periodontitis in smokers and non-smokers: A clinical and microbiological study.

The objective of the study is to assess the effects of adjunctive use of hyaluronic acid (HA), clinically and microbiologically in smokers and nonsmokers, in the management of chronic periodontitis. 48 sites from 24 chronic periodontitis patients, including smokers and nonsmokers with probing depth >5 mm, were selected for the study. A split-mouth design was followed. Scaling and root planing (SRP) was performed for all the patients. The test sites received 0.8% HA gel whereas the control site received placebo gel. The clinical parameters plaque, gingival and bleeding indices, Pocket Probing Depth (PPD), and clinical attachment level (CAL) were evaluated at baseline, 1 and 3 months. Microbiological parameters were evaluated at baseline and 1 month. The results showed reduction in PPD and gain in CAL in both smokers and nonsmokers at the end of 3rd month. The improvements in the test sites were statistically significant when compared with that of control sites. The microbiological analysis showed a significant reduction in Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis at the test sites when compared to the controls in both the groups. The findings in both groups suggest that the use of locally delivered 0.8% HA gel may be valuable as an adjunct to SRP in the treatment of chronic periodontitis.

Safety and Effectiveness of a Novel Hyaluronic Acid Gel for Lip Augmentation.

To compare the safety and efficacy of a novel hyaluronic acid injectable gel with 0.3% lidocaine (test device) with that of a commercially available injectable hyaluronic acid gel with 0.3% lidocaine (comparator) for lip augmentation. Eligible patients (n = 158) with an overall score of very thin (n = 0) or thin (n = 1) on a 5-point Lip Fullness Grading Scale (LFGS) participated in the double-blind, randomized, multicenter study. Efficacy was assessed periodically over 6 months on a per protocol (PP) population (definitive) and a modified intent-to-treat (mITT) population (supportive). In the PP population, the mean change from baseline (day 56) in LFGS score was 1.52 for the test device and 1.53 for the comparator. This 56-day change was the primary efficacy endpoint. The 95% confidence interval (CI) limits for the mean difference in scores (test device minus comparator) were -0.33 and 0.31. In the mITT population, the corresponding 95% CI limits were -0.26 and 0.31. In both populations, the lower limits, -0.33 and -0.26, were higher than the prespecified -0.50, indicating that the test device was non-inferior to comparator. The adverse event profile was similar between the treatment groups. Ninety-three percent of patients treated with test device considered themselves improved, much improved, or very much improved at day 168 compared to 82% of those treated with comparator. The corresponding investigator improvement ratings were 100% and 76%, respectively. For lip augmentation, the efficacy and safety of the test device is non-inferior to comparator. J Drugs Dermatol. 2022;21(1):13-20 doi:10.36849/JDD.6548.

Estimation of the healing effects of the topical use of MEBO and hyaluronic acid gel in the burned rats

Exposing the dorsal superficial skin of rats to partial-depth burn leads to bacterial and microbes Invasion. Topical treatment is required in most superficial burn cases Moist exposed burn ointment (MEBO) protects wounds from infection and enhances healing without any harmful effects of purified chemicals is caused. The topical using of HA gel in rat models with full and partial thickness surgical wounds shows enhancement in wound repair. In this study, we compared the healing efficacy of topica

Commentary on "Penile augmentation with injectable hyaluronic acid gel: an alternative choice for small penis syndrome".

Commentary on "Penile augmentation with injectable hyaluronic acid gel: an alternative choice for small penis syndrome".

Effectiveness of a Hybrid Hyaluronic Acid Gel for the Face and Neck in Men: Pilot Observation on Male Subjects

Introduction: While upper-class men had been taking care of themselves for centuries, this changed somewhat in the first half of the 20th century. And by the 1980s the cult of the body and the metrosexual man had emerged, with a marked upsurge in male cosmetic treatments. There was also an increased demand for treatment of wrinkles such as glabellar lines or nasolabial folds.

Clinical Comparison of Topical Application of Platelet Rich Fibrin Versus Application of Hyaluronic Acid Gel In Pain Management And Wound Healing After Free Gingival Graft Harvesting: A Randomized Controlled Clinical Trial.

Clinical Comparison of Topical Application of Platelet Rich Fibrin Versus Application of Hyaluronic Acid Gel In Pain Management And Wound Healing After Free Gingival Graft Harvesting: A Randomized Controlled Clinical Trial.

A randomized controlled trial evaluating hyaluronic acid gel as wound healing agent in alveolar ridge preservation.

To compare the results of administration of hyaluronic acid (HA) gel to no gel administration following alveolar ridge preservation (ARP) in terms of changes in wound dimensions over time. Systemically healthy patients scheduled for ARP at one or two sites in the incisor, cuspid, or premolar area with at least one neighbouring tooth and >50% buccal bone present following extraction were included. ARP consisted of socket grafting with collagen-enriched, deproteinized bovine bone mineral and socket sealing by means of a collagen matrix. Following surgical therapy, sites were randomly allocated to the control group (no gel application) or the test group (0.8% HA gel applied onto the collagen matrix three times per day for 7 days). Bucco-lingual and mesio-distal wound dimensions were registered at T0 (immediately post operation), T1 (1 week), and T2 (3 weeks). Patient-reported outcomes, clinical outcomes, and hard and soft tissue changes were recorded up to 4 months (T3). In the control group, 20 patients (7 males, 13 females; mean age 53.30) with 23 sites, and in the test group 18 patients (9 males, 9 females; mean age 52.56) with 23 sites, were included. There were no significant differences between the groups in the changes in wound dimensions from T0 to T2 (bucco-lingual aspect: p=.340; mesio-distal aspect: p=.883). Three sites (13%) in the control group and six (26%) in the test group demonstrated complete wound resolution at T2 (p= .259). HA failed to show any effect on the number of analgesics taken (p= .175), patient-reported outcomes (p ≥ .263), alveolitis (p= .136), socket healing (p ≥ .424), soft tissue changes (p ≥ .064), or mucosal scarring (p=.548). However, significantly more horizontal bone loss at the coronal aspect was found in the test group (p ≤ .025). HA failed to promote wound resolution on a collagen matrix. This study was registered in ClinicalTrials.gov (NCT04467736).

Bidirectional cell-matrix interaction dictates neuronal network formation in a brain-mimetic 3D scaffold

Human pluripotent stem cells (hPSC) derived neurons are emerging as a powerful tool for studying neurobiology, disease pathology, and modeling. Due to the lack of platforms available for housing and growing hPSC-derived neurons, a pressing need exists to tailor a brain-mimetic 3D scaffold that recapitulates tissue composition and favourably regulates neuronal network formation. Despite the progress in engineering biomimetic scaffolds, an ideal brain-mimetic scaffold is still elusive. We bioengineered a physiologically relevant 3D scaffold by integrating brain-like extracellular matrix (ECM) components and chemical cues. Culturing hPSCs-neurons in hyaluronic acid (HA) gels and HA-chondroitin sulfate (HA-CS) composite gels showed that the CS component prevails as the predominant factor for the growth of neuronal cells, albeit to modest efficacy. Covalent grafting of dopamine (DA) moieties to the HA-CS gel (HADA-CS) enhanced the scaffold stability and stimulated the gel's remodeling properties by entrapping cell-secreted laminin, and binding brain-derived neurotrophic factor (BDNF). Neurons cultured in the scaffold expressed Col1, Col11, and ITGB4; important for cell adhesion and cell-ECM signaling. Thus, the HA-CS scaffold with integrated chemical cues (DA) supported neuronal growth and network formation. This scaffold offers a valuable tool for tissue engineering and disease modeling and helps in bridging the gap between animal models and human diseases by providing biomimetic neurophysiology. Statement of significanceDeveloping a brain mimetic 3D scaffold that supports neuronal growth could potentially be useful to study neurobiology, disease pathology, and disease modeling. However, culturing human induced pluripotent stem cells (hiPSC) and human embryonic stem cells (ESCs) derived neurons in a 3D matrix is extremely challenging as neurons are very sensitive cells and require tailored composition, viscoelasticity, and chemical cues. This article identified the key chemical cues necessary for designing neuronal matrix that trap the cell-produced ECM and neurotrophic factors and remodel the matrix and supports neurite outgrowth. The tailored injectable scaffold possesses self-healing/shear-thinning property which is useful to design injectable gels for regenerative medicine and disease modeling that provides biomimetic neurophysiology.

Safety and Effectiveness of a Novel Hyaluronic Acid Gel for Lip Augmentation

Objective: To compare the safety and efficacy of a novel hyaluronic acid injectable gel with 0.3% lidocaine (test device) with that of a commercially available injectable hyaluronic acid gel with 0.3% lidocaine (comparator) for lip augmentation. Methods: Eligible patients (n = 158) with an overall score of very thin (n = 0) or thin (n = 1) on a 5-point Lip Fullness Grading Scale (LFGS) participated in the double-blind, randomized, multicenter study. Efficacy was assessed periodically over 6 months on a per protocol (PP) population (definitive) and a modified intent-to-treat (mITT) population (supportive). Results: In the PP population, the mean change from baseline (day 56) in LFGS score was 1.52 for the test device and 1.53 for the comparator. This 56-day change was the primary efficacy endpoint. The 95% confidence interval (CI) limits for the mean difference in scores (test device minus comparator) were -0.33 and 0.31. In the mITT population, the corresponding 95% CI limits were -0.26 and 0.31. In both populations, the lower limits, -0.33 and -0.26, were higher than the prespecified -0.50, indicating that the test device was non-inferior to comparator. The adverse event profile was similar between the treatment groups. Ninety-three percent of patients treated with test device considered themselves improved, much improved, or very much improved at day 168 compared to 82% of those treated with comparator. The corresponding investigator improvement ratings were 100% and 76%, respectively. Conclusion: For lip augmentation, the efficacy and safety of the test device is non-inferior to comparator. J Drugs Dermatol. 2022;21(1):13-20 doi:10.36849/JDD.6548Hyaluronic Acid Gel

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

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.

RGDSP-Decorated Hyaluronate Hydrogels Facilitate Rapid 3D Expansion of Amylase-Expressing Salivary Gland Progenitor Cells.

In vitro engineering of salivary glands relies on the availability of synthetic matrices presenting essential cell-instructive signals to guide tissue growth. Here, we describe a biomimetic, hyaluronic acid (HA)-based hydrogel platform containing covalently immobilized bioactive peptides derived from perlecan domain IV (TWSKV), laminin-111 (YIGSR, IKVAV), and fibronectin (RGDSP). The HA network was established by the thiol/acrylate reaction, and bioactive peptides were conjugated to the network with high efficiency without significantly altering the mechanical property of the matrix. When encapsulated as single cells in peptide-modified HA hydrogels, human salivary gland stem/progenitor cells (hS/PCs) spontaneously organized into multicellular spheroids with close cell-cell contacts. Conjugation of RGDSP and TWSKV signals in HA gels significantly accelerated cell proliferation, with the largest spheroids observed in RGDSP-tagged gels. Peptide conjugation did not significantly alter the expression of acinar (AMY1), ductal (TFCP2L1), and progenitor (KRT14) markers at the mRNA level. Characterization of three-dimensional (3D) cultures by immunocytochemistry showed positive staining for keratin-5 (K5), keratin-14 (K14), integrin-β1, and α-amylase under all culture conditions, confirming the maintenance of the secretory progenitor cell population. Two-dimensional (2D) adhesion studies revealed that integrin-β1 played a key role in facilitating cell-matrix interaction in gels with RGDSP, IKVAV, and TWSKV signals. Overall, conjugation of the RGDSP peptide to HA gels improved cell viability, accelerated the formation of epithelial spheroids, and promoted the expansion of the progenitor cell population in 3D. This work represents an essential first step toward the development of an engineered salivary gland.

Hyaluronic acid (HA)-Gd(III) and HA-Fe(III) microgels as MRI contrast enhancing agents

Hyaluronic acid (HA) was crosslinked with Gd(III) and Fe(III) ions rendering physically crosslinked HA-metal(III) microgels as magnetic resonance imaging (MRI) enhancing contrast agents. These HA-Gd(III) and HA-Fe(III) microgels are injectable with size range, 50–5000 nm in water. The same isoelectric point, pH 1.2 ± 0.1, was measured for both microgels. HA-Gd(III) and HA-Fe(III) microgels are hemo-compatible biomaterials and can be safely used in intravascular applications up to 1000 μg/mL concentration. Furthermore, no significant toxicity was attained as 95 ± 8 and 81 ± 2% cell viability on L929 fibroblast cells at 100 μg/mL of HA-Gd(III) and HA-Fe(III) microgels were measured. Moreover, HA-Gd(III) microgels were found to afford significant contrast improvement capability in MRI with proton relaxivity, r1 = 2.11 mM−1 s−1, comparable with the values reported for Gd(III) labeled functionalized HA gel systems and commercial Gd based contrast agents.

A randomized clinical trial of hyaluronic acid gel pulpotomy in primary molars with 1 year follow-up

Objective This randomized clinical study aimed to evaluate the success of hyaluronic acid (HA) as a pulpotomy medicament of human primary molars and to compare it with formocresol (FC) and ferric sulphate (FS) pulpotomy treatments up to 12 months. Materials and methods The study was conducted with 130 primary molars of 44 children. The ethical approval and registration to clinical trials (No: NCT04115358) were completed. After the removal of all the coronal pulp tissue, a 0.5% HA gel, or a FC, or a 20% FS solution were applied randomly to the radicular pulp tissues of the primary molars. Then, the pulp chambers were filled with a zinc oxide eugenol cement and restored either with a composite filling material or with a stainless-steel crown. The treatment success rates of the 3 groups were followed and compared clinically and radiographically at 1st-, 3rd-, 6th- and 12th-months. Results Primary molars treated with FC, FS and HA dressings were clinically successful 77.5%, 86.8% and 87.5% respectively after 12th-month follow-up (p > .05). Radiographic successes of FC, FS and HA groups were lower than clinical successes (57.6%, 68.8%, 57.9% respectively at the 12th-month) but the difference between the groups was not statistically significant (p > .05). Equivalence analysis assuming not more than 10% difference between the materials suggested that HA was not inferior to FC or FS. Conclusions Within the limitations of this study, our randomized clinical trial shows that HA is a promising pulpotomy medicament in primary molars. However, further studies are justified to further improve the HA material success.

Autocross-linked hyaluronic acid gel and adipose-derived mesenchymal stem cell composites for the treatment intrauterine adhesions

ObjectiveTo evaluate the effect of adding adipose-derived mesenchymal stem cells (ASCs) to autocross-linked hyaluronic acid (HA) gel for intrauterine adhesion (IUA) treatment. MethodsA rat IUA model was established by mechanical curettage and infection, and then different treatments were administered to the rats on day 7 after modeling. Ninety-six rats were randomly divided into the following groups: IUA model group, gel therapy group, and combination therapy group (HA gel combined with ASCs). Eight rats per group were sacrificed on days 7, 10, 14 and 21 for the subsequent experiments. Morphological changes were determined by hematoxylin-eosin staining and Masson staining. Smad3 and leukocyte inhibitory factor (LIF) were analyzed by quantitative real-time polymerase chain reaction and immunohistochemistry. ResultsThe endometrial lines in the gel therapy group and the combination therapy group were more complete than those in the model group. Masson staining showed that fibrosis area rates in the gel therapy group and the combination therapy group were significantly lower than those in the model group on day 7(P < 0.05). During the observation period, the fibrosis area rates in the combination therapy group remained lower than those in the model group (P < 0.05). The mRNA expression of Smad3 in the combination therapy group was lower than that in the model group and gel therapy group during the observation period (P < 0.05). The mRNA expression level of LIF in the combination therapy group was higher than that in the model group and the gel therapy group throughout the observation period (P < 0.05). ConclusionsHA gel was effective in preventing the IUA adhesion formation at the early stage of the observation period, while ASC enhanced this effect throughout the observation period. Gel and ASC composites helped to improve endometrial receptivity.

Safety and Effectiveness of Hyaluronic Acid Filler, VYC-20L, via Cannula for Cheek Augmentation: A Randomized, Single-Blind, Controlled Study.

Using cannulas to deliver facial fillers may reduce adverse events (AEs) compared with needle injection. To evaluate the safety and effectiveness of VYC-20L (20 mg/mL hyaluronic acid gel with lidocaine) via cannula for midface age-related volume deficit. This multicenter, evaluator-blind, randomized, within-subject, controlled study enrolled adults with moderate to severe Mid-Face Volume Deficit Scale (MFVDS) scores. VYC-20L was administered in one cheek via cannula (with optional needle use in the zygomaticomalar region) and in the other cheek via needle. The primary effectiveness end point was the mean (95% confidence interval [CI]) paired difference between treatments in MFVDS score change from baseline to Month 1; an upper CI limit of less than 0.5 determined noninferiority. Injection-site responses (ISRs), procedural pain, and AEs were assessed. Of 60 randomized and treated subjects, the mean change in MFVDS score from baseline to Month 1 was -1.8 with cannulas and -1.9 with needles, providing a mean (95% CI) paired difference of 0.1 (-0.05 to 0.25). Most ISRs were mild/moderate and resolved within 2 weeks. Procedural pain was minimal, and no serious AEs were reported. VYC-20L for cheek augmentation was safe and effective using a cannula and noninferior to needle injection.

Hyaluronic acid sustains platelet stability with prolonged growth factor release and accelerates wound healing by enhancing proliferation and collagen deposition in diabetic mice

Platelet Rich Plasma (PRP) has gained significant attention in diabetic wound management due to the presence of growth factors. However, its short self-life ex vivo limits its clinical use. Among the biopolymers hyaluronic acid (HA), offers higher biocompatibity with bioactivity and ideal polymer properties for delivery of the cell based products. Hence, here HA gel matrix was prepared to hold PRP to prolong the growth factor stability. PRP prepared from healthy donors was used after characterizing total platelets (3.0 ± 0.17 × 106 cells/mL) and PDGF-BB levels (156.37 ± 1.73 ng/mL). This was subsequently entrapped in1:3 ratios of PRP:HA gel. The prepared gels were stored at different conditions to study growth factor stability. The prepared gels showed near neutral pH (6.99) with shear thickening properties. On the 15th day of storage at −20 °C temperature, the PDGF-BB levels in the PRP stored directly reduced by 35.98% while HA-PRP gels it reduced by 20.91%. Considerably higher cell proliferation (43.11%) and migration (85%) were observed on treatment with gels stored at −20 °C for 15 days compared to the PRP stored directly. Topical application of the gels on diabetic mice showed complete wound contraction by 15th day compared to untreated groups. Enhanced collagen and cytokeratin 10 depositions were observed owing to the synergistic effect of the polymer protein combination. These results are suggestive of HA-PRP gels as topical applicants for treating diabetic wounds and using PRP into a mainstream treatment strategy in clinical practices.