[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585006":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":47,"centralContacts":52,"locations":63,"responsibleParty":90,"collaborators":93,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":57,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":57,"studyType":109,"phases":110,"briefSummary":113,"conditions":114,"keywords":57,"overallStatus":65,"whyStopped":57,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Tang-Du Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosome Group (ME-UCMSC-Exo)","EXPERIMENTAL","Participants in this arm will receive hysteroscopically guided intra-endometrial injection of 1-1.5 mL mechanically engineered umbilical cord mesenchymal stem cell-derived exosomes (ME-UCMSC-Exo) containing approximately 5×10¹⁰ particles\u002FmL during the proliferative phase (Day 3-7 of the menstrual cycle).\n\nThe exosomes are obtained from mechanically preconditioned UC-MSC cultures, which are subjected to biomechanical stress during expansion to enhance regenerative properties.\n\nThe study aims to evaluate the efficacy of ME-UCMSC-Exo in improving endometrial thickness and pregnancy outcomes in patients with thin endometrium secondary to intrauterine adhesions.",[13],"Biological: Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional Umbilical Cord Mesenchymal Stem Cell-Derived Exosome Group (UCMSC-Exo)","Participants in this arm will receive hysteroscopically guided intra-endometrial injection of 1-1.5 mL conventional umbilical cord mesenchymal stem cell-derived exosomes (UCMSC-Exo) containing approximately 5×10¹⁰ particles\u002FmL during the proliferative phase (Day 3-7 of the menstrual cycle).\n\nUnlike the ME-UCMSC-Exo group, these exosomes are obtained from standard UC-MSC cultures without mechanical stress preconditioning.\n\nThis group serves as a comparator to determine whether mechanical preconditioning enhances exosome efficacy in endometrial regeneration and pregnancy outcomes.",[18],"Biological: Umbilical cord mesenchymal stem cell-derived exosomes",{"label":20,"type":21,"description":22,"interventionNames":23},"Platelet-Rich Plasma (PRP) Control Group","ACTIVE_COMPARATOR","Participants in this arm will receive hysteroscopically guided intra-endometrial injection of 1-1.5 mL autologous PRP following standard PRP preparation protocols during the proliferative phase (Day 3-7 of the menstrual cycle).\n\nPRP contains growth factors such as platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor-beta (TGF-β), which have been shown to improve endometrial receptivity and pregnancy outcomes.\n\nThis group serves as a positive control for assessing the efficacy of exosome-based therapies.",[24],"Biological: platelet-rich plasma",[26,34,41],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes","Mechanically engineered umbilical cord mesenchymal stem cell-derived exosomes (ME-UCMSC-Exo) are isolated from umbilical cord-derived mesenchymal stem cells (UCMSCs) subjected to mechanical stress conditioning during in vitro expansion. This process enhances exosome yield, bioactivity, and regenerative capacity. The exosomes are purified via ultracentrifugation and characterized for size, protein markers, and RNA content.\n\nIn this study, ME-UCMSC-Exo is administered via intra-endometrial injection under hysteroscopic guidance. Each participant in this intervention group will receive 1-1.5 mL of exosome solution (containing approximately5\\*10\\^10 particles\u002FmL) per injection site during the proliferative phase (Day 3-7 of the menstrual cycle). The aim is to enhance endometrial thickness, receptivity, and pregnancy outcomes in patients with thin endometrium secondary to intrauterine adhesions.",[9],[32,33],"ME-UCMSC-Exo","RH-Exo",{"type":27,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Umbilical cord mesenchymal stem cell-derived exosomes","Umbilical cord mesenchymal stem cell-derived exosomes (UCMSC-Exo) are obtained from standard cultured UCMSCs without mechanical stress preconditioning. These exosomes undergo identical purification and characterization procedures as ME-UCMSC-Exo but lack biomechanical priming. UCMSC-Exo is also administered intra-endometrially via hysteroscopic injection at a dose of 1-1.5 mL (5\\*10\\^10 particles\u002FmL) per site.",[15],[39,40],"UCMSC-Exo","TCP-Exo",{"type":27,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"platelet-rich plasma","Platelet-rich plasma (PRP) is an autologous biological preparation obtained from centrifuged whole blood. It contains a high concentration of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and vascular endothelial growth factor (VEGF), which promote endometrial regeneration.\n\nIn this study, PRP will be administered via hysteroscopically guided intra-endometrial injection at a dose of 1-1.5 mL per injection site, following standard PRP preparation protocols. This group serves as a positive control for evaluating the efficacy of exosome-based therapies.",[20],[46],"PRP",[48],{"name":49,"affiliation":50,"role":51},"The Fourth Military Medical University","Air Force Military Medical University, China","PRINCIPAL_INVESTIGATOR",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Wanlin Zhang, PhD","CONTACT","+86 18149363396",null,"1843678023@qq.com",{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},"Yafei Tong, MD","+86 13720750251","fequeo1820@126.com",[64,79],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Xi'an","Shaanxi","710038","China","CN",{"type":72,"coordinates":73},"Point",[74,75],108.92861,34.25833,{"lat":75,"lon":74},[78],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},{"type":72,"coordinates":81},[74,75],{"lat":75,"lon":74},[84,86,87,88],{"name":54,"role":55,"phone":85,"phoneExt":57,"email":58},"+86 029-84717216",{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},{"name":54,"role":51,"phone":57,"phoneExt":57,"email":57},{"name":60,"role":89,"phone":57,"phoneExt":57,"email":57},"SUB_INVESTIGATOR",{"type":51,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"zhangwanlin","Associate Chief Physician",[94],{"name":95,"class":6},"Xi'an Jiaotong University","100585006","phase-1-evaluating-mechanically-engineered-stem-cell-exosomes-for-treating-endometrial-injury-a-clinical-study-100585006",false,"NCT06896747","Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study","Evaluation of the Therapeutic Effects of Mechanically Engineered Umbilical Cord-Derived Stem Cell Exosomes on Endometrial Injury: A Prospective, Non-Randomized, Parallel-Controlled Clinical Study","Inclusion Criteria:\n\n1. Females aged 20-40 years (inclusive of boundary values);\n2. Normal ovarian reserve function (criteria: AFC ≥ 7, AMH \\> 1.1 ng\u002FmL);\n3. History of transcervical resection of adhesions (TCRA);\n4. Received PRP treatment after TCRA;\n5. At least one embryo transfer (ET) cycle in which they underwent standard ovarian stimulation (fresh cycle) or standard hormone replacement therapy (FET cycle), with an endometrial thickness of \\\u003C7 mm;\n6. Planned to continue IVF\u002FICSI\u002FFET-assisted conception;\n7. Able to accept and adhere to treatment and follow-up and willing to sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients with severe systemic diseases, surgical contraindications, or cycle contraindications;\n2. Patients with reproductive tract infections, genital tuberculosis, pelvic inflammatory disease, or malignant tumors of reproductive organs;\n3. Patients with systemic diseases that cause uterine bleeding;\n4. Patients allergic to any drugs, materials, or components used in this study;\n5. Patients at high risk for hormone-dependent tumors such as breast cancer or ovarian tumors;\n6. Patients with untreated submucosal fibroids of any size (FIGO 0\u002FI\u002FII), uterine fibroids ≥5 cm (FIGO III, IV, V, VI, VII), adenomyosis, unicornuate uterus, bicornuate uterus, or endometrial polyps;\n7. Patients with hydrosalpinx ≥3 cm or hydrosalpinx of any size with significant vaginal discharge;\n8. Patients with ovarian endometriotic cysts (chocolate cysts) ≥4 cm;\n9. Patients who participated in other clinical trials within 3 months before surgery or during the study period;\n10. Patients unable to tolerate anesthesia;\n11. Patients with genetic abnormalities;\n12. Other patients deemed unsuitable for participation in this study by the investigator.","FEMALE","20 Years","40 Years",{"count":107,"type":108},90,"ESTIMATED","INTERVENTIONAL",[111,112],"PHASE1","PHASE2","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.\n\nThe main questions it aims to answer are:\n\nCan 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.\n\nParticipants will:\n\nReceive either mechanical exosomesor or conventional esosomes or PRP through subendometrial injection.\n\nBe monitored for changes in endometrial parameters.",[115,116,117],"Thin Endometrial Lining","Female Infertility","Intrauterine Adhesions","2025-03-19",{"date":120,"type":121},"2025-03-26","ACTUAL",{"date":123,"type":121},"2025-02-21",{"date":125,"type":108},"2027-03-31",{"name":5,"class":6},2]