Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

Exclusion Criteria18

• 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
• If a vital sign or lab value results in exclusion, the subject could be rescreened later