Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

In this Phase 1, single site, clinical trial, Vulvar/vaginal Smooth muscle cells (SMC) and Epithelial Cells (EPC) are isolated from autologous patient's biopsy

Inclusion Criteria:Diagnosed with congenital Mullerian duct anomaly that includes absence or obliteration of all or part of the vagina, as confirmed on pelvic MRIFemales between the ages of 15 and 45 yearsPatients with stable medical comorbiditiesPatients that are willing to comply with all study instructions and are willing to return for study follow-up visitsExclusion Criteria:Patients with a history of surgery in the target area more recent than the last 6 monthsPatients with an active vaginal area infection or urinary infection as evidenced by clinical exam or culture resultPatients with a history of keloid scarringPatients who are currently taking anti-platelet medications or blood thinnersPatients with a history of clotting disorderPatients with autoimmune disease or immune disorderPatients requiring concomitant use of or treatment with immunosuppressive agentsPatients 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 studyPatients with evidence or diagnosis of any primary coagulation disorder (including concomitant anticoagulation therapy at enrollment)Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this studyPatients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)Patients who are current tobacco usersPatients with alcohol/drug abuse problemsPatients with any systemic diseasePatients with any psychiatric disordersInability to participate in all necessary study activities due to physical or mental limitations.Any circumstance in which the investigator deems participation in the study is not in the subject's best interestThe 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 <90 millimeters of mercury (mmHg) or diastolic >100 or<60 millimeters of mercury (mmHg) Pulse <60 or >105bpm Respiratory Rate < 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) < 60 mL/min/ 1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) HbA1C > 8% Hb <10 mg/dL Platelet Count <100,000 O2 saturation <95%If a vital sign or lab value results in exclusion, the subject could be rescreened later