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NCT07101484
Intrauterine adhesions (IUA) remain highly prevalent in China, with incidence rates steadily increasing due to the rising number of intrauterine procedures. Literature reports indicate that IUA caused by repeated induced abortions, curettage, postpartum infections, and other intrauterine surgeries occurs in 25%-30% of cases, making it a leading cause of reduced menstrual flow, cyclic abdominal pain, recurrent miscarriage, and secondary infertility, significantly impairing women's reproductive health and overall well-being. Currently, no effective treatment exists for severe IUA to fully restore fertility and normal menstrual physiology. The commonly used hysteroscopic adhesiolysis (TCRA) has a high recurrence rate of 62.5%, with a post-operative pregnancy success rate of only 22.5%-33.3%. Therefore, there is an urgent clinical need to explore novel therapeutic strategies for severe intrauterine adhesions. Exosomes derived from induced pluripotent stem cells (iPS-Exo) offer significant advantages over MSC-derived exosomes due to their clonal origin, ensuring superior batch-to-batch consistency and stability. This feature enables more stringent quality control standards and facilitates standardized, scalable production and quality management systems. Compared to mesenchymal stem cells (MSCs) or MSC-derived exosomes, iPS-Exo exhibit multiple superior properties: 1. Higher potency of bioactive components: * As iPSCs represent an earlier differentiation stage than MSCs, iPS-Exo contain elevated levels of functional factors such as TGF-β (anti-inflammatory), BDNF (neurotrophic), and others. * Demonstrated biological effects: * Anti-apoptosis * Inflammation suppression * Angiogenesis promotion * Fibrosis inhibition * Enhanced tissue repair potential 2. Enhanced pharmaceutical suitability: * Clonal expansion ensures product homogeneity and manufacturing reproducibility. * Simplified quality control metrics compared to heterogeneous MSC-Exo. 3. Genetic engineering compatibility: o Amenable to precision modification for targeted therapeutic enhancement. 4. Preclinical efficacy evidence: * Neuroprotection: Superior to MSC-Exo in mitigating neuronal damage induced by oxygen-glucose deprivation and hydrogen peroxide-induced oxidative stress. * Epilepsy models: Significant reduction in seizure frequency/severity and decreased cerebral IL-6/TNF-α levels in treated mice. * Stroke models: Intravenous administration: * Suppressed Th1/Th17 immune responses post-ischemia * Increased Treg cell proportion * Modulated immune microenvironment * Reduced infarct volume and improved motor function * Enhanced survival rates Compared to small-molecule drugs or MSC-Exo with limited mechanisms, iPS-Exo demonstrate broader therapeutic potential for ischemic stroke, drug-resistant epilepsy, and other disorders. However, their application in treating endometrial damage from intrauterine adhesions (IUA) remains unexplored to date. Goodain (Beijing) Pharmaceutical Technology Co., Ltd., a biotechnology company specializing in induced pluripotent stem cells (iPSCs) and exosome technologies, holds GMP laboratory certification. The company has independently developed clinical-grade iPSC-derived exosomes (iPS-Exo), which have been investigated in four investigator-initiated exploratory clinical trials across different indications, with no reported adverse events (AEs) or serious adverse events (SAEs) to date. Preclinical Rationale Our research team previously conducted preclinical studies using umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exo) in a rat model of intrauterine adhesions (IUA). Results demonstrated that: • Intrauterine perfusion of MSC-Exo significantly promoted: * Endometrial regeneration in mechanically injured rats * Increased endometrial gland density * Enhanced cellular proliferation * Higher embryo implantation rates These findings support the translational potential of exosome-based therapies for IUA. Study Objective Building on this preclinical evidence, we propose the first-in-human safety evaluation of clinical-grade iPS-Exo for moderate-to-severe IUA. This study aims to: 1. Establish preliminary safety profiles 2. Explore therapeutic efficacy signals 3. Address the unmet clinical need in severe IUA management Key Advantages * Regulatory-ready: GMP-certified production ensures batch consistency. * Clinical precedence: Favorable safety data from prior exploratory trials. * Mechanistic validation: Proven endometrial repair effects in animal models.
NCT06896747
The goal of this clinical trial is to evaluate if engineered mechanically umbilical cord-derived stem cell exosomes, or conventional umbilical cord -derived stem cell exosomes, can improve endometrial thickness in women with thin endometrium. The main questions it aims to answer are: Can exosomes delivered via subendometrial injection improve endometrial thickness or clinical pregnancy rates compared to PRP (platelet-rich plasma)? Are there significant differences in endometrial thickness between the two treatment groups? Researchers will compare the intervention groups, which one group receives mechanical exosomes and the other receives conventional esosomes via subendometrial injection, to the control group, which receives PRP via the same methods, to see if exosomes provide superior therapeutic effects. Participants will: Receive either mechanical exosomesor or conventional esosomes or PRP through subendometrial injection. Be monitored for changes in endometrial parameters.
NCT06608407
Asherman syndrome, which occurs after trauma to the basalis layer of the endometrium. It seems that the role of postoperative platelet rich plasma（PRP）therapy in the prevention of recurrence of IUA is still controversial. To investigate if PRP therapy can prevent adhesion reformation after adhesiolysis. After the completion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: having PRP after hysteroscopic adhesiolysis; and the control group without PRP treatment. A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.
NCT06620978
Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions. It is performed with an optic device while entering liquid media to the uterus to allow visualization. Diagnostic procedures are often performed without anaesthesia (in the office setting) and operative procedures are performed either under general anaesthesia or without anaesthesia (in the office setting). It depends on the patients' characteristics and preferences, and surgical indications. 80%-100% of operative procedure without anesthesia can be successfully completed. The main reasons for inability to successfully complete operative hysteroscopy without anesthesia are patients' discomfort and limited visibility of the uterine cavity. In the current study, the investigators will compare the use of two different pressure setting of the liquid media during operative hysteroscopy without anesthesia, with the aim of investigating the successful completion of the procedure and patient's discomfort, with the aim of determining the optimal pressure setting.
NCT05414760
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
NCT03578172
Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).
NCT04936347
In this prospective, randomized controlled trial，the investigators wish to explore the difference of therapeutic effect and prognosis between "hot knife" and "cold knife" in the treatment of uterine adhesion under hysteroscopy.
NCT04975373
Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups. 1. study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity 2. control group - no injection 4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in Israel. during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded.
NCT03724617
This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.
NCT04637373
Retained products of conception (RPOC) and intrauterine adhesions (IUA) may occur following suction curettage for early miscarriage and cause secondary infertility, recurrent pregnancy loss and pregnancy complications. The aim of this study is to investigate whether adding hysteroscopy to suction curettage reduces the rates of RPOC and IUA.
NCT03381807
This project will investigate the safety and effectiveness of human amniotic epithelial stem cells for treatment of severe refractory Asherman's syndrome.
NCT04308811
The aim of the study is to find out the benefit of the platelet-rich plasma in preventing reformation of intrauterine adhesions after adhesiolysis in cases of Asherman syndrome
NCT03731689
This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis.
NCT02855632
The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.
NCT03353909
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.
NCT03346317
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can improve clinical outcomes? Therefore, this study was conducted.
NCT03330873
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.
NCT02313415
Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness for the treatment of uterine infertility.
NCT02220621
Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as symptoms such as abdominal pain, hypomenorrhea or amenorrhea, sterility and habitual abortion, which seriously affect the patients quality of life. Preventing IUA has been tried using different methods such as barrier or stent in order to separate the opposing endometrium during the tissue healing processes. Although some successes have been reported there are still some challenges need to be dealt with. One of the barrier materials for preventing IUA is made of hyaluronic acid (HA). HA is a natural ECM of human tissue with excellent biocompatibility and promotes the scar-free wound repair. The self-crosslinked esterified HA gel has demonstrated the capacity to prevent IUA in clinical studies. A novel self-crosslinked HA gel is developed by BioRegen Biomedical（Changzhou）Co., Ltd with proprietary technologies. This product is a highly viscoelastic crosslinked gel that overcomes the shortcoming of sodium hyaluronate with high motility and too quick degradation in vivo. For this product, the results of animal experiments and various safety features have been designed and tested conforming to the national regulations and standards. In order to launch this product to the market, this prospective, randomized and controlled clinical trial is designed and will be performed to verify its safety/efficacy.
NCT01167296
To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if leaving it in the uterus will cause uterine infection.