Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

The cells are expanded in vitro and seeded on scaffold and matured - The final Tissue Engineered Vagina (TEV) is implanted into the native vaginal site

Inclusion criteria

• Diagnosed with congenital Mullerian duct anomaly that includes absence or obliteration of all or part of the vagina, as confirmed on pelvic MRI
• Females between the ages of 15 and 45 years
• Patients with stable medical comorbidities
• Patients that are willing to comply with all study instructions and are willing to return for study follow-up visits

Exclusion criteria

• Patients with a history of surgery in the target area more recent than the last 6 months
• Patients with an active vaginal area infection or urinary infection as evidenced by clinical exam or culture result
• Patients with a history of keloid scarring
• Patients who are currently taking anti-platelet medications or blood thinners
• Patients with a history of clotting disorder
• Patients with autoimmune disease or immune disorder
• Patients requiring concomitant use of or treatment with immunosuppressive agents
• 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
• Patients 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 study
• Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
• Patients who are current tobacco users
• Patients with alcohol/drug abuse problems
• Patients with any systemic disease
• Patients with any psychiatric disorders
• Inability 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 interest
• 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 <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