[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-mullerian-duct-anomaly\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-mullerian-duct-anomaly":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100491176","phase-1-implantation-of-vaginal-construct-for-patients-with-vaginal-aplasia-100491176",false,"NCT05675722","Implantation Of Vaginal Construct For Patients With Vaginal Aplasia","Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia","TEV","Inclusion Criteria:\n\n* Diagnosed with congenital Mullerian duct anomaly that includes absence or obliteration of all or part of the vagina, as confirmed on pelvic MRI\n* Females between the ages of 15 and 45 years\n* Patients with stable medical comorbidities\n* Patients that are willing to comply with all study instructions and are willing to return for study follow-up visits\n\nExclusion Criteria:\n\n* Patients with a history of surgery in the target area more recent than the last 6 months\n* Patients with an active vaginal area infection or urinary infection as evidenced by clinical exam or culture result\n* Patients with a history of keloid scarring\n* Patients who are currently taking anti-platelet medications or blood thinners\n* Patients with a history of clotting disorder\n* Patients with autoimmune disease or immune disorder\n* Patients requiring concomitant use of or treatment with immunosuppressive agents\n* Patients with a history of systemic conditions, including but not limited to HIV, thrombocytopenia, uncontrolled diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study\n* Patients with evidence or diagnosis of any primary coagulation disorder (including concomitant anticoagulation therapy at enrollment)\n* Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study\n* Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)\n* Patients who are current tobacco users\n* Patients with alcohol\u002Fdrug abuse problems\n* Patients with any systemic disease\n* Patients with any psychiatric disorders\n* Inability to participate in all necessary study activities due to physical or mental limitations.\n* Any circumstance in which the investigator deems participation in the study is not in the subject's best interest\n* The following vital sign cut-off values, laboratory cut-off values and ECG reading will be monitored as the exclusion criteria in the biopsy visit and again before the implantation surgery BP systolic \\>160 or \\\u003C90 millimeters of mercury (mmHg) or diastolic \\>100 or\\\u003C60 millimeters of mercury (mmHg) Pulse \\\u003C60 or \\>105bpm Respiratory Rate \\\u003C 9 and \\>20 Temp \\> 100.4 degrees Fahrenheit Liver enzymes \\>2 times the upper limit of normal (ULN) Abnormal bilirubin unless subject has Gilbert's glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F 1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) HbA1C \\> 8% Hb \\\u003C10 mg\u002FdL Platelet Count \\\u003C100,000 O2 saturation \\\u003C95%\n* If a vital sign or lab value results in exclusion, the subject could be rescreened later","FEMALE","15 Years","45 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","In this Phase 1, single site, clinical trial, Vulvar\u002Fvaginal Smooth muscle cells (SMC) and Epithelial Cells (EPC) are isolated from autologous patient's biopsy",[28],"Congenital Mullerian Duct Anomaly",[30],"Vaginal Abnormality","RECRUITING","2026-10-05",{"date":34,"type":35},"2026-10-09","ACTUAL",{"date":37,"type":35},"2023-06-01",{"date":39,"type":22},"2029-12",{"name":41,"class":42},"Wake Forest University Health Sciences","OTHER"]