Juveena Hydrogel System for Asherman's Syndrome
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Rejoni Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing if Juveena hydrogel can safely and effectively reduce scar tissue formation in women who have had certain types of uterine surgeries. The gel is applied inside the uterus to prevent the walls from sticking together during healing.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use systemic corticosteroids within 1 week of the study procedure or have long-acting injectable hormones that would still be active at the time of the procedure.
What data supports the idea that Juveena Hydrogel System for Asherman's Syndrome is an effective treatment?
The available research shows that hyaluronic acid gel, which is similar to Juveena Hydrogel, is effective in preventing the reformation of adhesions after surgery for Asherman's Syndrome. This suggests that Juveena Hydrogel could also be effective in treating the condition. Compared to other treatments like intrauterine balloons and contraceptive devices, hyaluronic acid gel has been shown to be beneficial in preventing adhesions, which supports the effectiveness of Juveena Hydrogel.
12345What safety data is available for the Juveena Hydrogel System for Asherman's Syndrome?
The provided research does not contain any specific safety data for the Juveena Hydrogel System or its variants. The studies focus on other medical devices and treatments, such as vaginal mesh implants, levonorgestrel intrauterine systems, and vaginal energy-based devices, none of which are related to the Juveena Hydrogel System.
678910Is the Juveena Hydrogel System a promising treatment for Asherman's Syndrome?
Yes, the Juveena Hydrogel System is a promising treatment for Asherman's Syndrome. It uses hydrogels, which are special gels that can deliver healing substances directly to the damaged area in the uterus. This helps in repairing the tissue and improving fertility. The system can also release these substances slowly over time, making the treatment more effective.
311121314Eligibility Criteria
This trial is for premenopausal women at high risk of developing intrauterine adhesions, such as those needing hysteroscopic procedures like adhesiolysis or myomectomy. Participants must agree to avoid hormonal contraception and IUDs, not be pregnant or breastfeeding, have no history of certain cancers or infections, and commit to study requirements.Inclusion Criteria
Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.
I agree not to use hormonal birth control or IUDs until after Week 8 of the study.
Subject has signed the IRB/EC approved informed consent
+4 more
Exclusion Criteria
I have had surgery inside my uterus within the last 2 months.
Pregnant (positive pregnancy test) or lactating.
I have not taken any corticosteroids in the last week.
+11 more
Participant Groups
The study tests if the Juveena Hydrogel System can prevent scarring inside the uterus after a procedure that could cause these adhesions. Women will either receive this new hydrogel treatment along with their surgery (TCGP + Juveena) or just the surgery alone to compare outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Transcervical Gynecological Procedure + Juveena HydrogelExperimental Treatment1 Intervention
Transcervical Gynecological Procedure + Juveena Hydrogel
Group II: Transcervical Gynecological Procedure alone (standard of care)Active Control1 Intervention
Transcervical Gynecological Procedure alone (standard of care)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas at Austin Dept of Womens' HealthAustin, TX
Generations Fertility CareMiddleton, WI
Maimonides Medical CenterBrooklyn, NY
Duke Universtiy Health SystemMorrisville, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Rejoni Inc.Lead Sponsor
References
Prevention of de novo adhesion formation in patients with Asherman's syndrome. [2021]To summarize recent data and knowledge of secondary prevention of the recurrence of intrauterine adhesions in patients with Ashermans syndrome.
Autologous platelet-rich plasma treatment for moderate-severe Asherman syndrome: the first experience. [2022]Treatment of Asherman syndrome (AS) presents a significant clinical challenge. Based on our in vitro data showing that PRP could activate endometrial cell proliferation and migration, we hypothesized that intrauterine infusion of autologous platelet-rich plasma (PRP) may improve endometrial regeneration and fertility outcomes in patients with moderate-severe AS.
A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. [2022]To compare the efficacy of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of the adhesion reformation after hysteroscopic adhesiolysis for Asherman's syndrome.
Treatment of Asherman's syndrome in an outpatient hysteroscopy setting. [2022]To evaluate the feasibility and success rate of treating Asherman syndrome in an outpatient hysteroscopy unit.
Auto-Cross-Linked Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions after Hysteroscopic Adhesiolysis: A Randomized Controlled Trial. [2021]To investigate auto-cross-linked hyaluronic acid gel for the prevention of intrauterine adhesion (IUA) recurrence after hysteroscopic adhesiolysis.
User testing a patient information resource about potential complications of vaginally inserted synthetic mesh. [2021]Vaginal mesh implants are medical devices used in a number of operations to treat stress urinary incontinence and pelvic organ prolapse. Although many of these operations have delivered good outcomes, some women have experienced serious complications that have profoundly affected their quality of life. To ensure that evolving patient information is up-to-date, accurate and appropriate, the Transvaginal Mesh Oversight Group 'user-tested' a newly developed Scottish patient resource, the first to focus exclusively on the issue of complications. The aim of this research was to gather feedback on usability, content, language and presentation to inform the development of the resource from a user perspective.
Acceptability of the levonorgestrel intrauterine system in the long-term treatment of heavy menstrual bleeding: how many women choose to use a second device? [2013]To assess the acceptability of the levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena®) in the long-term treatment of heavy menstrual bleeding.
Contemporary comparison between retropubic midurethral sling and autologous pubovaginal sling for stress urinary incontinence after the FDA advisory notification. [2015]To compare the efficacy and safety in a contemporary cohort of women who were offered either a pubovaginal sling (PVS) or a synthetic midurethral sling (MUS) after the U.S. Food and Drug Administration notification and made an informed decision on procedure option.
Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage. [2021]In 2017, concerns regarding adverse events (AEs) associated with the Mirena levonorgestrel intrauterine device were largely echoed in the media in France. This resulted in a tremendous reporting of AEs to pharmacovigilance centres. The aim of this study was to describe the reporting of AEs regarding Mirena in France and to study the impact of media coverage on this reporting.
Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. [2021]Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning.
Bioengineered endometrial hydrogels with growth factors promote tissue regeneration and restore fertility in murine models. [2021]Extracellular matrix (ECM) hydrogels obtained from decellularized tissues are promising biocompatible materials for tissue regeneration. These biomaterials may provide important options for endometrial pathologies such as Asherman's syndrome and endometrial atrophy, which lack effective therapies thus far. First, we performed a proteomic analysis of a decellularized endometrial porcine hydrogel (EndoECM) to describe the specific role of ECM proteins related to regenerative processes. Furthermore, we investigated the ability of a bioengineered system-EndoECM alone or supplemented with growth factors (GFs)-to repair the endometrium in a murine model of endometrial damage. For this model, the uterine horns of female C57BL/6 mice were first injected with 70% ethanol, then four days later, they were treated with: saline (negative control); biotin-labeled EndoECM; or biotin-labeled EndoECM plus platelet-derived GF, basic fibroblast GF, and insulin-like GF 1 (EndoECM+GF). Endometrial regeneration and fertility restoration were evaluated by assessing the number of glands, endometrial area, cell proliferation, neaoangiogenesis, reduction of collagen deposition, and fertility restoration. Interestingly, regenerative effects such as an increased number of endometrial glands, increased area, high cell proliferative index, development of new blood vessels, reduction of collagen deposition, and higher pregnancy rate occurred in mice treated with EndoECM+GF. Thus, a bioengineered system based on EndoECM hydrogel supplemented with GFs may be promising for the clinical treatment of endometrial conditions such as Asherman's syndrome and endometrial atrophy. STATEMENT OF SIGNIFICANCE: In the last years, the bioengineering field has developed new and promising approaches to regenerate tissues or replace damaged and diseased tissues. Bioengineered hydrogels offer an ideal option because these materials can be used not only as treatments but also as carriers of drugs and other therapeutics. The present work demonstrates for the first time how hydrogels derived from pig endometrium loaded with growth factors could treat uterine pathologies in a mouse model of endometrial damage. These findings provide scientific evidence about bioengineered hydrogels based on tissue-specific extracellular matrix offering new options to treat human infertility from endometrial causes such as Asherman's syndrome or endometrial atrophy.
Hydrogel, a novel therapeutic and delivery strategy, in the treatment of intrauterine adhesions. [2022]Intrauterine adhesions (IUAs) are caused by damage to the underlying lining of the endometrium. They' re related to disorder of endometrial repair. In recent years, hydrogels with controllable biological activity have been widely used for treating IUAs. They encapsulate estrogen, cytokines, cells, or exosomes, forming a delivery system to release therapeutic components for the treatment of IUAs. In addition, the hydrogel acting as a barrier can be degraded in the body automatically, reducing the risk of infection caused by secondary surgeries. In this review, we summarize the recent progress of hydrogels and their application in IUAs as both a novel alternative therapeutic and an artificial delivery strategy.
Three-dimensional structure micelles of heparin-poloxamer improve the therapeutic effect of 17β-estradiol on endometrial regeneration for intrauterine adhesions in a rat model. [2018]Intrauterine adhesions (IUA) frequently occur after infectious or mechanical injury to the endometrium, which may lead to infertility and/or pregnancy complications. There are few effective treatments due to the complex function of endometrium and shortage of native materials. 17β-estradiol (E2) is commonly used as an ancillary treatment in IUA patients, but it is limited by its poor solubility in aqueous solutions and low concentrations at the injured sites. In this research, a mini-endometrial curette was used to injure the rat's endometrium to form an IUA model. 17β-estradiol was encapsulated into the micelles of heparin-poloxamer and a thermosensitive hydrogel (E2-HP hydrogel) was formed. This sustained releasing system was applied to restore the structure and function of the injured uterus. E2-HP hydrogel was constructed and relevant characteristics including gelation temperature and micromorphology were evaluated. Sustained release of 17β-estradiol from HP hydrogel was performed both in vitro and in vivo. Ultrasonography measurement and pathologic characteristics on the IUA rats were performed to evaluate the therapeutic effect of E2-HP hydrogel. Endoplasmic reticulum (ER) stress-related apoptosis was analyzed to explore the possible mechanisms in IUA recovery. E2-HP hydrogel showed a prolonged release of E2 at the targeting region and more effective endometrium regeneration in IUA rats. Significant improvements in both gland numbers and fibrosis area were observed in the E2-HP hydrogel group. We also demonstrated that E2-HP hydrogel in the recovery of IUA was closely related to the suppression of ER stress signals via the activation of downstream signals, PI3K/Akt and ERK1/2. HP hydrogel might be an effective approach to deliver E2 into the injured endometrium. Therapeutic strategies targeting ER stress using E2-HP hydrogel might be a promising solution for the treatment of women with intrauterine adhesions.
Hyaluronic Acid Hydrogel Integrated with Mesenchymal Stem Cell-Secretome to Treat Endometrial Injury in a Rat Model of Asherman's Syndrome. [2023]Stem cell therapies have made strides toward the efficacious treatment of injured endometrium and the prevention of intrauterine adhesions, or Asherman's syndrome (AS). Despite this progress, they are limited by their risk of tumor formation, low engraftment rates, as well as storage and transportation logistics. While attempts have been made to curb these issues, there remains a need for simple and effective solutions. A growing body of evidence supports the theory that delivering media, conditioned with mesenchymal stem cells, might be a promising alternative to live cell therapy. Mesenchymal stem cell-secretome (MSC-Sec) has a superior safety profile and can be stored without losing its regenerative properties. It is versatile enough to be added to a number of delivery vehicles that improve engraftment and control the release of the therapeutic. Thus, it holds great potential for the treatment of AS. Here, a new strategy for loading crosslinked hyaluronic acid gel (HA gel) with MSC-Sec is reported. The HA gel/MSC-Sec treatment paradigm creates a sustained release system that repairs endometrial injury in rats and promotes viable pregnancy.