EpiVaginal

Vaginal irritation testing—prospects of human organotypic vaginal tissue culture models

Personal lubricants intended for local or systemic delivery via the vaginal route can induce vaginal irritation, damage the vaginal epithelial barrier which can enhance microbial entry, induce infammation, and alter the microbiome of the vaginal ecosystem. Therefore, manufacturers of personal lubricants and medical devices are required to show biocompatibility and safety assessment data to support […]

Qualification of a non-animal vaginal irritation method admitted as nonclinical assessment model (NAM) in the Incubator Phase of the United States Food and Drug Administration (US FDA) Medical Devices Development Tool (MDDT)

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) classifies personal lubricants as Class II medical devices. Because of this status and the nature of body contact common to personal lubricants, CDRH reviewers routinely recommend a standard biocompatibility testing battery that includes: an in vivo rabbit vaginal irritation (RVI) test; […]

Characterization of an air-liquid interface primary human vaginal epithelium to study Ebola virus infection and testing of antivirals

Ebola virus (EBOV) is the causative agent of the often-fatal Ebola virus disease (EVD) characterized by hemorrhagic fever in humans and non-human primates. Sexual transmission from male survivors has been at the origin of multiple outbreak flare-ups between 2015 and 2021. However, this route is still poorly understood and the resulting EVD from it is […]

Production and characterization of a human antisperm monoclonal antibody against CD52g for topical contraception in women

Approximately 40% of human pregnancies are unintended, indicating a need for more acceptable effective contraception methods. New antibody production systems make it possible to manufacture reagent-grade human monoclonal antibodies (mAbs) for clinical use. We used the Nicotiana platform to produce a human antisperm mAb and tested its efficacy for on-demand topical contraception.

Toxicity Assessment of Resveratrol Liposomes-in-Hydrogel Delivery System by EpiVaginal™ Tissue Model

The natural polyphenol resveratrol (RES) has shown great potential as an antimicrobial, including against microbes associated with vaginal infections. To fully exploit the activities of RES, an all-natural ingredients formulation for RES delivery at vaginal site has been developed, namely liposomes loaded with RES, incorporated into a chitosan hydrogel as secondary vehicle. Although considered non-toxic […]

Surfactant Protein D Reverses the Gene Signature of Transepithelial HIV-1 Passage and Restricts the Viral Transfer Across the Vaginal Barrier

Effective prophylactic strategy against the current epidemic of sexually transmitted HIV-1 infection requires understanding of the innate gatekeeping mechanisms at the genital mucosa. Surfactant protein D (SP-D), a member of the collectin family of proteins naturally present in the vaginal tract, is a potential HIV-1 entry inhibitor at the cellular level. Human EpiVaginal tissues compartmentalized […]

Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone

Background Ensuring menstrual cup safety is paramount, yet a menstrual cup safety assessment scheme is lacking. This paper presents a quadripartite scheme, showing how it can be applied. Methods The Tampax Menstrual Cup was evaluated in the safety assessment scheme: (1) Biocompatibility and chemical safety of cup constituents. Extractables were obtained under different use condition; […]

The Impact of Over-The-Counter Lactic Acid Containing Vaginal Gels on the Integrity and Inflammatory State of the Vaginal Epithelium in vitro

The vaginal microbiome influences a wide range of health outcomes in women, where a microbiome dominated by Lactobacillus spp. is considered optimal and associated with reduced risk of pre-term birth and acquisition of sexually transmitted infections including HIV. Conversely, replacement of lactobacilli by non-optimal bacteria leads to the development of bacterial vaginosis, which is associated […]

In vitro -in vivo assay validation for vaginal irritation of chemicals

 The goal of the study is to validate the utility of the 3D human in vitro vaginal tissue model as an alternate for rabbit vaginal irritation using a set of coded test articles (TAs). A double-blinded study was conducted in which the investigator and the animal testing facility were provided with N=14 coded TAs and […]

Interaction of Gardnerella vaginalis and Vaginolysin with the Apical versus Basolateral Face of a Three-Dimensional Model of Vaginal Epithelium

Studies have implicated Gardnerella vaginalis as an important etiological agent in bacterial vaginosis (BV). It produces a cholesterol-dependent cytolysin, vaginolysin (VLY). In this study, we sought to characterize the interaction between vaginal epithelium, G. vaginalis, and VLY using EpiVaginal tissues from Mattek. These tissues are three-dimensional and have distinct apical and basolateral sides, enabling comparison […]

Novel Vaginal Microflora Colonization Model Providing New Insight into Microbicide Mechanism of Action

Several broad-spectrum microbicides, including cellulose sulfate (CS), have passed conventional preclinical and phase I clinical safety evaluation and yet have failed to protect women from acquiring IDV -1 in phase II/Ill trials. Concerns have been raised that current preclinical algorithms are deficient in addressing the complexity of the microflora-regulated vaginal mucosal barrier. We applied a […]

Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a three-dimensional vaginal epithelium model

Most of the widely used vaginal lubricants in the U.S. and Europe are strongly hyperosmolal, formulated with high concentrations of glycerol, propylene glycol, polyquaternary compounds or other ingredients that make these lubricants 4 to 30 times the osmolality of healthy vaginal fluid. Hyperosmolal formulations have been shown to cause marked toxicity to human colorectal epithelia in vivo, and […]

IDENTIFICATION OF ENDOCRINE DISRUPTORS USING AN ORGANOTYPIC VAGINAL TISSUE MODEL.

Environmental or occupational exposure to a broad variety of chemical agents can alter normal endocrine function. The effects of these “endocrine disruptors” (ED) can have serious health implications including deleterious effects to reproductive capacity, fetal development, the immune system, and carcinogenesis. Current animal tests are expensive, use a large number of animals, and are not […]

SIMULTANEOUS DETECTION AND SEMIQUANTIFICATION OF DNA DAMAGE IN NORMAL AND APOPTOTIC CELLS: TRIPLE-IMMUNOFLUORESCENT LABELING USING DAPI, ANTIBODIES, AND TUNEL.

We developed a triple-labeling immunofluorescence technique that simultaneously identifies total DNA (DAPI), DNA damage (antibodies), and dead cells [terminal deoxynucleotidyl transferase-mediated dUTP nick end-labeling (TUNEL)-positive cells] and a method that semiquantifies DNA damage in paraffin-embedded tissues. Using this technique in combination with our analysis method, scientists can now simultaneously detect and compare the relative amounts […]

ASSESSMENT OF AN IN VITRO HUMAN VAGINAL EPITHELIAL MODEL FOR PREDICTING VAGINAL IRRITATION.

Currently, the vaginal irritation potential of chemical ingredients and finished products is assessed using the in vivo rabbit irritation model. A viable in vitro method would be of great value to the personal care industry. In this study, the EpiVaginal™ reconstructed human epithelial model was evaluated for its ability to predict vaginal irritation of six […]

PREVENTION OF VAGINAL SHIV TRANSMISSION IN MACAQUES BY A LIVE RECOMBINANT LACTOBACILLUS.

Most human immunodeficiency virus (HIV) transmissions in women occur through the cervicovaginal mucosa, which is coated by a bacterial biofilm including Lactobacillus . This commensal bacterium has a role in maintaining a healthy mucosa and can be genetically engineered to produce antiviral peptides. Here, we report a 63 % reduction in transmission of a chimeric […]

CONCORDANCE BETWEEN DIFFERENT IN VITRO CULTURE MODELS DESIGNED TO PREDICT VAGINAL IRRITATION AND/OR TOXICITY.

The safety profile of potential microbicides is equally, if not more important than anti-HIV activity. At the very least, candidates must not impair natural defences against HIV-1 infection or cause inflammation. In this study, researchers at St. George’s Hospital Medical School (UK) and the International Partnership for Microbicides (IPM) investigated the concordance between five different […]

PRECLINICAL EVALUATION OF LIME JUICE AS A TOPICAL MICROBICIDE CANDIDATE.

This study by researchers in the CONRAD (Contraceptive Research and Development) Program at Eastern Virginia Medical School and at St. George’s University/London demonstrated how Mattek’s EpiVaginal in vitro human cervico-vaginal tissue equivalent can be used pre-clinically to test potentially cytotoxic microbicide formulations in vitro. Background: The continued growth of the global HIV epidemic highlights the […]

RECONSTRUCTED VAGINAL-ECTOCERVICAL AND ENDOCERVICAL TISSUE MODELS FOR HSV-2, CHLAMYDIA, AND GONORRHEA INFECTIONS.

Despite extensive efforts, limited success has been achieved in developing tissue models for sexually transmitted infections (STIs) such as herpes simplex virus 2 (HSV-2), Chlamydia trachomatis (Ct), and Neisseria gonorrhea (Ng). The purpose of this study was to utilize highly differentiated, normal human 3-dimensional (NHu-3D) models of human vaginal ectocervical (VEC) and endocervical (VEN) tissues […]

ACTIVITY AND SAFETY OF SYNTHETIC LECTINS BASED ON BENZOBOROXOLE-FUNCTIONALIZED POLYMERS FOR INHIBITION OF HIV ENTRY.

Lectins derived from plant and microbial sources constitute a vital class of entry inhibitors that target the oligomannose residues on the HIV envelope gp120. Despite their potency and specificity, success of lectin-based entry inhibitors may be impeded by high manufacturing costs, formulation and potential mitogenicity. Therefore, there exists a gap in the HIV microbicides pipeline […]

ANTI-GP120 MINIBODY GENE TRANSFER TO FEMALE GENITAL EPITHELIAL CELLS PROTECTS AGAINST HIV-1 VIRUS CHALLENGE IN VITRO.

Background:  Although cervico-vaginal epithelial cells of the female lower genital tract provide the initial defense system against HIV-1 infection, the protection is sometimes incomplete. Thus, enhancing anti-HIV-1 humoral immunity at the mucosal cell surface by local expression of anti-HIV-1 broadly neutralizing antibodies (BnAb) that block HIV-1 entry would provide an important new intervention that could […]

UPDATE ON VALIDATION STATUS AND INDUSTRY UTILIZATION OF NORMAL HUMAN 3D (NHU-3D) ANIMAL ALTERNATIVE MODELS.

Progress in in vitro tissue engineering over the last several decades has contributed to a significant decrease in animal use for industrial risk and safety assessment of products and ingredients. Mattek Corporation has a long-standing involvement in development, production and validation of animal alternative in vitro models produced from normal human cells (NHu-3D models). The […]

REGULATORY REQUIREMENTS FOR IN VITRO SYSTEMS TO MEET PERFORMANCE STANDARDS OVER TIME AS WELL AS DURING VALIDATION.

This technical poster by scientists at Mattek Corp. summarized 12-PLUS YEARS (1996-2007) of commercial production QC data for Mattek’s EpiDerm and EpiOcular in vitro human tissue equivalents, and how that data addresses regulatory concerns regarding performance standards of alternative in vitro testing methods over time. In vitro models are being proposed as alternatives to animal […]

EPIVAGINAL TISSUE MODEL FOR PRECLINICAL SCREENING OF SINGLE OR REPEAT EXPOSURE TO VAGINALLY APPLIED CHEMICALS/FORMULATIONS.

A predictive test system for assessing the vaginal irritation potential of chemicals and formulations will have far reaching application in the testing of feminine care products. The vaginal mucosa is commonly exposed to chemicals and therapeutic agents that may result in irritation/inflammation which can make women susceptible to infections such as HIV-1 and HSV-2. Hence, […]

A NEW MODEL FOR STUDIES ON CERVICOVAGINAL INFLAMMATION AND BARRIER DISRUPTION.

INTRODUCTION: Several microbicide candidates have failed in recent clinical trials due to the induction of vaginal inflammation and epithelial barrier disruption. New preclinical models are needed for assessing inflammation and barrier disruption of the vaginal epithelium, and for testing effects of microbicides in an inflammatory environment. OBJECTIVE: The purpose of this study was to establish […]

STUDIES ON VAGINAL INNATE IMMUNITY IN THE EPIVAGINAL MODEL.

This study by researchers at Boston University School of Medicine and Mattek Corp. demonstrated that the EpiVaginal full thickness human cervico-vaginal tissue equivalent can provide valuable information on molecular mechanisms of vaginal innate immunity, and serve as a test system to determine effects of microbicides on vaginal immune defense. Background: The Mattek EpiVaginal™ (EV) full […]

STUDIES ON VAGINAL INNATE IMMUNITY IN THE EPIVAGINAL MODEL SYSTEM.

As stated in the “Conclusions” section, this study by Mattek Corp. scientists demonstrated that the EpiVaginal human ectocervical-vaginal tissue equivalent provided valuable information on molecular mechanisms of vaginal innate immunity, and served as a test system to determine the effects of microbicides on vaginal immune defense. Background: The Mattek EpiVaginal tissue model, grown on tissue […]

RECONSTRUCTION OF VAGINAL TISSUE MODEL FOR HIV INFECTION.

The HIV/AIDS epidemic is continuing to escalate worldwide and it is estimated that through the year 2000, more than 34 million people have already been infected with the virus. Daily, 16,000 individuals acquire HIV-1 infection and the majority of all adult HIV infections (90%) are obtained through sexual contact. The cervico-vaginal tissues are thought to […]

THE RETROCYCLIN ANALOGUE RC-101 PREVENTS HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 INFECTION OF A MODEL HUMAN CERVICOVAGINAL TISSUE CONSTRUCT.

This study by researchers at the University of Central Florida, University of Pittsburgh and UCLA School of Medicine demonstrated that Mattek’s EpiVaginal human vaginal-ectocervical tissue equivalent can be used to test the toxicity and efficacy of potential HIV-1 topical microbicides. Retrocyclins are cyclic antimicrobial peptides that exhibit potent activity towards a broad range of primary […]

ORGANOTYPIC HUMAN VAGINAL-ECTOCERVICAL TISSUE MODEL FOR IRRITATION STUDIES OF SPERMICIDES, MICROBICIDES, AND FEMININE-CARE PRODUCTS.

This study by scientists at Boston University School of Medicine and Mattek Corp. demonstrated that Mattek’s EpiVaginal in vitro human cervico-vaginal tissue equivalent is a highly reproducible, non-animal means to assess the irritation potential of topically applied contraceptives, microbicides and vaginal care products. EpiVaginal, a three-dimensional organotypic vaginal-ectocervical (VEC) tissue model, has been developed to […]

IN VITRO ASSESSMENT OF PERSONAL CARE PRODUCTS FOR VAGINAL IRRITATION USING 3D TISSUE CONSTRUCTS.

Three dimensional (3D) human vaginal-ectocervical tissue constructs may be a relevant in vitro model to rapidly screen for vaginal mucosal irritation potential of raw materials and final formulations. Here we report results from a study with an in vitro vaginal tissue construct (EpiVaginal™ from Mattek Corporation, USA), used to predict irritation responses of a variety […]

ENHANCED ANTIVIRAL ACTIVITY OF ACYCLOVIR LOADED INTO NANOPARTICLES.

The activity of antivirals can be enhanced by their incorporation in nanoparticulate delivery systems. Peculiar polymeric nanoparticles, based on a β-cyclodextrin-poly (4-acryloylmorpholine) monoconjugate (β-CD-PACM), are proposed as acyclovir carriers. The experimental  procedure  necessary to obtain the acyclovir-loaded nanoparticles  using  the  solvent displacement  preparation  method   will be described   in  this  chapter.   Fluorescent labeled   nanoparticles are prepared […]

REVERSIBLE DEFICIENCY OF ANTIMICROBIAL POLYPEPTIDES IN BACTERIAL VAGINOSIS.

This study by researchers from the University of California at Los Angeles (UCLA) demonstrated that Mattek’s EpiVaginal human vaginal ecto-cervical tissue equivalent containing dendritic cells can be used to examine the interactions between pathological alterations of vaginal flora and the composition and antimicrobial properties of vaginal fluid. Bacterial vaginosis is a common condition associated with […]

SAFETY TESTING OF SILICONE ELASTOMER MATRIX VAGINAL RINGS CONTAINING UC781 AND TWEEN 80 USING EPIVAGINAL(VEC-606) TISSUES.

The microbicidal agent UC781 has very limited aqueous solubility. A recent study in pig-tailed macaques showed poor pharmacokinetic levels, suggesting that, unlike in vitro release testing which uses relatively large volumes of a hydroalcoholic release media, the vaginal environment does not provide equivalent solubilising power to dissolve UC781 diffused from the ring. To overcome this […]

ENGINEERING A DEGRADABLE POLYURETHANE INTRAVAGINAL RING FOR SUSTAINED DELIVERY OF DAPIVIRINE

We describe the engineering of a degradable intravaginal ring (IVR) for the delivery of the potent HIV-1 reverse transcriptase inhibitor dapivirine. The degradable polymer used in fabricating the device incorporated poly(caprolactone) ester blocks in a poly(tetramethylene ether) glycol ABA type polyurethane backbone. The polymer was designed to maintain its structure for 1 month during usage and […]

PRECLINICAL EVALUATION OF ANTI-HIV MICROBICIDE PRODUCTS: NEW MODELS AND BIOMARKERS.

A safe and effective microbicide product designed to prevent sexual transmission of HIV-1 rests on a solid foundation provided by the proper selection and preclinical characterization of both its active pharmaceutical ingredient (API) and formulation. The evaluation of API and formulation physicochemical properties, drug release, specific antiviral activity, cell and tissue toxicity, organ toxicity, pharmacokinetics, […]

VAGINAL MICROBICIDE GEL FOR DELIVERY OF IQP-0528, A PYRIMIDINEDIONE ANALOG WITH A DUAL MECHANISM OF ACTION AGAINST HIV-1.

Pyrimidinediones, a novel class of compounds, have previously been shown to possess antiviral activity at nanomolar concentrations. One member of this class of compounds, IQP-0528, was selected as the lead molecule for formulation development owing to its stability at physiologically relevant conditions, wide therapeutic window, and antiviral activity in the nanomolar range. Here, we report […]

PRECLINICAL EVALUATION OF UC781 MICROBICIDE VAGINAL DRUG DELIVERY.

UC781 is a potent nonnucleoside reverse transcriptase inhibitor being investigated as a potential microbicide to prevent transmission of HIV-1 both vaginally and rectally. This study was designed to investigate the in vitro drug release, in vitro permeability/safety, and in vivo pharmacokinetics in rabbits of a vaginal gel prepared with micronized or nonmicronized UC781 (UC781m and […]

DEVELOPMENT OF A COMBINATION MICROBICIDE GEL FORMULATION CONTAINING IQP-0528 AND TENOFOVIR FOR THE PREVENTION OF HIV INFECTION.

In light of the increasing worldwide AIDS pandemic, there is a continuing need to develop new prevention strategies to inhibit the transmission of HIV-1. In the absence of a successful vaccine, topical microbicides represent the best strategies to reduce the epidemic. Following the success of HIV therapeutic cocktail strategies, combinations of microbicides including nucleotide reverse […]

IN VITRO SAFETY PROFILE OF PERSONAL CARE PRODUCTS – USE OF AN IN VITRO TESTING PLATFORM BASED ON A RECONSTRUCTED VAGINAL TISSUE MODEL

One of the common goals of industry is to confirm the safety of their products. Ethical concerns have led to the use of alternative testing methods in lieu of traditional testing methods. Several studies have shown good correlation between alternative test methods, traditional testing methods and human exposure. In the current study, the safety profile […]

HUMAN VAGINAL-ECTOCERVICAL TISSUE MODEL FOR MICROBICIDE IRRITATION STUDIES.

Infection through the vaginal-ectocervical (VEC) tissue is believed to be the main route for the heterosexual transmission of the human immunodeficiency virus (HIV) in women. Recently, a tissue culture-based model of the VEC (EpiVaginal) has been developed. Normal, human VEC epithelial and dendritic cell co-cultures were used to form a three-dimensional tissue using specially formulated […]

HUMAN TISSUE MODEL FOR VAGINAL IRRITATION STUDIES.

Recently, EpiVaginal™, a tissue culture-based model of the vaginal epithelium, has been developed. Normal, human ectocervico-vaginal (ECV) epithelial cells were induced to form a three-dimensional tissue using specially formulated serum free medium. The in vitro tissue reproduces many of the histological, ultrastructural, and protein expression properties of native tissue, including a multilayered three-dimensional morphology, inter-digitation […]

SAFETY STUDY OF AN ANTIMICROBIAL PEPTIDE LACTOCIN 160, PRODUCED BY THE VAGINAL LACTOBACILLUS RHAMNOSUS.

This study by researchers at the Royal Institute of Technology (Sweden), Rutgers University, Rush Medical Center, Health Promoting Naturals, Inc., and The Women’s Hospital of Texas demonstrated the ability to use Mattek’s EpiVaginal in vitro human organotypic vaginal-ectocervical tissue model to determine the irritation potential of an antimicrobial peptide. Purpose: To evaluate the safety of […]

HUMAN VAGINAL—ECTOCERVIAL TISSUE MODEL TO TEST THE IRRITATION POTENTIAL OF CONTRACEPTIVE AND VAGINAL-CARE PRODUCTS.

DEVELOPMENT OF AN IN VITRO ALTERNATIVE ASSAY METHOD FOR VAGINAL IRRITATION.

The vaginal mucosa is commonly exposed to chemicals and therapeutic agents that may result in irritation and/or inflammation. In addition to acute effects, vaginal irritation and inflammation can make women more susceptible to infections such as HIV-1 and herpes simplex virus 2 (HSV-2). Hence, the vaginal irritation potential of feminine care formulations and vaginally administered […]

PRE-VALIDATION OF RECONSTRUCTED EPIVAGINAL TISSUE MODEL TO SCREEN IRRITATION POTENTIAL OF CHEMICALS.

BIOCOMPATIBILITY OF SOLID DOSAGE ANTI-HIV-1 MICROBICIDES AND VAGINAL PRODUCTS WITH THE MUCOSAL CYTOKINE NETWORK.

RECONSTRUCTED HUMAN VAGINAL-ECTOCERVICAL TISSUE MODELS.

Acquired immunodeficiency syndrome (AIDS) is now the fourth most common cause of death worldwide. In the last 20 years, more than 60 million people have been infected with the virus. By the end of 2002, an estimated 42 million people globally were living with HIV and the majority of new infections occurred in young adult […]

VAGINAL FORMULATION – HOW INNOCUOUS ARE THEY TO THE VAGINAL EPITHELIAL IMMUNE FUNCTION?

This study by researchers in the Harvard Medical School Dept. of Obstetrics and Gynecology demonstrated that Mattek’s EpiVaginal in vitro human cervico-vaginal tissue equivalent is an excellent tissue model for performing both immunoinflammatory characterization and safety assessment of vaginal products. Problem: The disruption of the epithelial barrier and activation of inflammatory pathways may lead to […]

ASSESSMENT OF ORGANOTYPIC EPIVAGINALTM TISSUE MODEL TO SCREEN IRRITATION POTENTIAL OF CHEMICALS.

A predictive test system for assessing the vaginal irritation of chemicals and formulations will have far reaching application in industries involved in feminine care products. The vaginal mucosa is commonly exposed to chemicals or therapeutic agents that can cause irritation/inflammation and increase the susceptibility to infections such as HIV-1 and HSV-2. Hence, chemical/formulation or therapeutic […]

IRRITATION TESTING OF CONTRACEPTIVE AND FEMININE-CARE PRODUCTS USING EPIVAGINAL, AN IN VITRO HUMAN VAGINAL-ECTOCERVICAL TISSUE MODEL.

ORGANOTYPIC ECTOCERVICO-VAGINAL TISSUE MODEL CONTAINING DENDRITIC CELLS.

Acquired immunodeficiency syndrome (AIDS) is now the fourth most common cause of death worldwide. In the last 20 years, more than 60 million people have been infected with the virus. By the end of 2001, an estimated 40 million people globally were living with HIV, and the majority of new infections occurred in young adult […]

Characterization of a Hormone-Responsive Organotypic Human Vaginal Tissue Model: Morphologic and Immunologic Effects

Estrogen and progesterone regulate proliferation and differentiation of epithelial cells in the female genital tract. We investigated the effects of these hormones on reconstructed human organotypic vaginal epithelial tissue models (EpiVaginal). We ascertained that epithelial cells in the tissue models express estrogen and progesterone receptors. Treatment with estradiol-17β (E2) significantly increased epithelium thickness and transepithelial […]

DISRUPTION OF TIGHT JUNCTIONS BY CELLULOSE SULFATE FACILITATES HIV INFECTION: MODEL OF MICROBICIDE SAFETY.

This study by researchers in the Departments of Pediatrics, Microbiology-Immunology and Medicine at Albert Einstein College of Medicine demonstrated that Mattek’s EpiVaginal in vitro 3-D human cervico-vaginal tissue equivalent can be used to model potential epithelial barrier disruption caused by microbicide candidate formulations, and how epithelial barrier disruption leads to increased risk of HIV infection. […]

VISUALIZING INDIVIDUAL, FLUORESCENTLY TAGGED HIV-1 VIRIONS IN CERVICAL TISSUE.

This study by researchers at the Northwestern University School of Medicine demonstrated how Mattek’s EpiVaginal human cervico-vaginal tissue equivalent can be used in the development of methodologies to visualize the interaction of HIV-1 virus with cervical mucosa/tissue. Background: The majority of new cases of HIV in women are sexually transmitted, however, controversy remains concerning the […]

TRICHOMONAS VAGINALIS LIPOPHOSPHOGLYCAN TRIGGERS A SELECTIVE UPREGULATION OF CYTOKINES BY HUMAN FEMALE REPRODUCTIVE TRACT EPITHELIAL CELLS.

This study by researchers at Brigham and Women’s Hospital/Harvard Medical School, Cornell University, Boston University School of Medicine, and SUNY Upstate Medical University demonstrated that Mattek’s EpiVaginal human cervico-vaginal tissue equivalent can be used to study in vitro the molecular pathways important in initiating host inflammatory and immune responses to Trichomonas vaginalis. Trichomonas vaginalis is […]

TRANSFER OF IgG IN THE FEMALE GENITAL TRACT BY MHC CLASS I-RELATED NEONATAL FC RECEPTOR (FCRN) CONFERS PROTECTIVE IMMUNITY TO VAGINAL INFECTION.

IgG is a major Ig subclass in mucosal secretions of the human female genital tract, where it predominates over the IgA isotype. Despite the abundance of IgG, surprisingly little is known about where and how IgG enters the lumen of the genital tract and the exact role local IgG plays in preventing sexually transmitted diseases. […]

EXPRESSION AND FUNCTION OF BACTERICIDAL/PERMEABILITY – INCREASING PROTEIN IN HUMAN GENITAL TRACT EPITHELIAL CELLS.

This study by researchers at Brigham and Women’s Hospital/Harvard Medical School demonstrated that Mattek’s EpiVaginal human cervico-vaginal tissue equivalent expresses bactericidal/permeability-increasing protein (BPI) and that this protein’s role in regulating bacterial colonization in the genital mucosa can be studied in vitro using EpiVaginal tissues. Genital tract epithelia regularly encounter and adapt to the existence of […]

GENOTOXICITY TESTING USING THE NORMAL HUMAN CELL BASED 3D EPITHELIAL MODELS.

Safety assessment of new products for human use requires genotoxicity testing to ensure their non-carcinogenicity. Current in vitro genotoxicity assays have low specificity resulting in unacceptably high rates of false positives. Moreover, starting in 2009, in vivo genotoxicity testing was banned by the 7th Amendment to the Cosmetics Directive. Since epithelial tissues have the highest […]

HYDROGEN PEROXIDE MEDIATED TRANSVAGINAL DRUG DELIVERY.

Simple, safe and effective permeability enhancers are crucial for successful non-invasive drug delivery methods. We seek local permeability augmentation mechanisms for integration into passive or active architectures in order to enable novel therapeutic delivery routes of the target drug while minimizing drug formulation challenges. This study explores the efficacy of hydrogen peroxide (HP) as a […]

EVALUATION OF RECONSTITUTED HUMAN VAGINAL EPITHELIUM AS A MODEL FOR DRUG DELIVERY OF FLUCONAZOLE GEL FOR TREATING VULVOVAGINAL CANDIDIASIS.

Purpose: The goal of this project performed by researchers at the Massachusetts College of Pharmacy and Health Sciences was to evaluate the use of EpiVaginal, a reconstituted human vaginal epithelium, as a model for penetration for an antifungal gel containing fluconazole. A tissue culture based model for vaginal epithelium (EpiVaginal) has been developed by Mattek […]

REAWAKENING RETROCYCLINS: ANCESTRAL HUMAN DEFENSINS ACTIVE AGAINST HIV-1. (REPORT).

This study by researchers at the University of Massachusetts showed that Mattek’s EpiVaginal in vitro 3-D human cervico-vaginal tissue equivalent can be used to demonstrate the ability to restore endogenous expression of retrocyclin peptides. Human alpha and beta defensins contribute substantially to innate immune defenses against microbial and viral infections. Certain nonhuman primates also produce […]

SPERMICIDAL ACTIVITY OF THE SAFE NATURAL ANTIMICROBIAL PEPTIDE SUBTILOSIN.

This study by researchers at Rutgers University, Rush University Medical Center, The Royal Institute of Technology, Health Promoting Naturals, Inc., and The Women’s Hospital of Texas demonstrated that Mattek’s EpiVaginal in vitro human cervico-vaginal tissue equivalent can be used to accurately mimic the results of prolonged exposure of novel compounds to this human tissue type […]

CATIONIC POLYPEPTIDES ARE REQUIRED FOR ANTI-HIV-1-ACTIVITY OF HUMAN VAGINAL FLUID.

This study by researchers at the University of Central Florida Biomolecular Science Center demonstrated that Mattek’s EpiVaginal human cervico-vaginal tissue equivalent is an excellent in vitro model for investigating HIV-1 infection via the mucosal surfaces of the vagina, as well as agents that may inhibit/prevent this route of HIV-1 infection, because of the tissue’s ability […]

PSORIASIN (S100A7) IS A MAJOR ANTIMICROBIAL COMPONENT OF THE FEMALE GENITAL TRACT.

This study by researchers at the Medical University of Vienna and University Hospital Schleswig-Holstein demonstrated that Mattek’s EpiVaginal in vitro 3-D human cervico-vaginal tissue equivalent can be used to confirm psoriasin expression when the tissue was exposed to IL-1alpha and to secreted components of E. coli. Psoriasin has been shown to be the major Escherichia […]

CHARACTERIZATION AND EVALUATION OF CD34+ GENERATED LANGERHANS CELLS FOR TISSUE ENGINEERING.

Specialized antigen-presenting cells (APC), particularly Langerhans cells (LC) residing in the skin, mucosa, and lymphoid tissues play a key role in sensitization and other immunological reactions of the body. However, difficulty in harvesting, short survival time in culture, and variability in cytokine production of cultured LC has prevented researchers from widespread use of LC for […]

NORMAL HUMAN DENDRITIC CELLS: A TOOL TO STUDY ALLERGIC AND IMMUNOLOGICAL REACTIONS IN VITRO.

Dendritic cells (DC) or Langerhans cells (LC) are immunological cells of the body which play a key role in allergic reactions and infectious diseases. However, widespread experimental use of DC has not occurred since previously-used methods of harvesting DC directly from tissue result in poor yields, short survival time, and rapid phenotypic changes. Currently, we […]