Overview
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
Description
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
Eligibility
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